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Mala
ria R
apid
Diag
nost
ic Te
st Pe
rform
ance
Re
sults
of W
HO p
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4 (2
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Malaria Rapid Diagnostic Test Performance
Results of WHO product testing of malaria RDTs: Round 4 (2012)
Malaria Rapid Diagnostic Test Performance
Results of WHO product testing of malaria RDTs: 4 (2012)
WHO Library Cataloguing-in-Publication Data :Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 4 (2012).1.Malaria - diagnosis. 2.Antimalarials - therapeutic use. 3.Malaria - drug therapy. 4.Diagnostic tests, Routine. 5.Reagent kits, Diagnostic - utilization. 6.Sensitivity and specificity. I.UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases. II.Centers for Disease Control (U.S.). III.Foundation for Innovative New Diagnostics.
ISBN 978 92 4 150472 0 (NLM classification: WC 750)
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) I I I
Contents acknoWledgeMents Viii
abbreViations X
1. sUMMarY perforMance of Malaria rdts: WHo prodUct testing: roUnds 1–4 11.1. introduction 11.2. the WHo product testing programme 11.3. results of the evaluation 21.4. summary of outcomes 31.5. Use of these results 3
2. WHo Malaria rdt prodUct testing: roUnd 4 eXecUtiVe sUMMarY 172.1. introduction 172.2. the WHo product testing programme 172.3. results of the evaluation 182.4. Use of these results 18
3. backgroUnd 19
4. objectiVe 21
5. Materials and MetHods 215.1. test selection 215.2. outline of the product testing protocol 215.3. evaluation panels 245.4. rdt registration 255.5. specimen panel registration 255.6. test phases 255.7. performing rapid tests 255.8. interpretation of results 26
6. data ManageMent 27
7. QUalitY assUrance 27
8. etHical considerations 28
9. data analYsis 289.1. Measures of parasite detection: panel detection score
and positivity rates 289.2. false-positive results 28
9.2.1. incorrect species identification 299.2.2. false-positives from plasmodium-negative samples 29
9.3. band intensity 299.4. lot agreement 299.5. invalid tests 299.6. Heat (thermal) stability 29
10. laboratorY VersUs field-based Malaria rdt eValUations 30
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)IV
11. resUlts 3111.1. summary 3111.2. phase 1 - p. falciparum culture panel 3611.3. phase 2 - Wild-type p. falciparum and p. vivax
and plasmodium spp. negative samples 3711.3.1. p. falciparum detection 3711.3.2. p. vivax detection 3811.3.3. combined detection of p. falciparum and p. vivax 3811.3.4. p. falciparum and p. vivax positivity rate 3911.3.5. band intensity 4011.3.6. false-positive rates 40
12. Heat stabilitY 4412.1. p. falciparum test lines 4712.2. pan-specific test lines 49
13. ease-of-Use description 51
14. discUssion of keY findings 5514.1. panel detection score (pds) and its relationship
to sensitivity 5514.2. false-positive rate and specificity 5614.3. Heat (thermal) stability 5714.4. ease-of-use description 5714.5. inter-lot variability 5814.6. target antigens and species 58
15. Using tHese resUlts to ensUre QUalitY of diagnosis in tHe field 5915.1. beyond procurement 5915.2. lot testing 59
16. conclUsions 60
17. references 60
anneXes 63annex 1: characteristics of rapid malaria tests in round 4 64annex 2: Malaria rdt guide to results interpretation 67annex 3: phase 1 results 82annex 4: phase 2 results 86annex 5a: selection of an appropriate rdt 118annex 5b: Malaria rdt field assessment and rdt anomalies 119annex 6: introducing rdt-based malaria diagnosis into national programmes 122
Reference to any company or product in this report, particularly in any of the figures or tables, does not in any way imply an endorsement, certification, warranty of fitness or recommendation by WHO of any company or product for any purpose, and does not imply preference over products of a similar nature that are not mentioned. WHO furthermore does not warrant that: (1) any list of companies or products is complete and/or error free; and/or that (2) any products listed are of acceptable quality, have obtained regulatory approval in any country, or that their use is otherwise in accordance with the national laws and regulations of any country, including but not limited to patent laws. Inclusion in this report does not furthermore imply any approval by WHO of the products in question (which is the sole prerogative of national authorities). Any lists of RDTs are not an exhaustive list of malaria RDTs. Such lists reflect those products which have been submitted for evaluation in Round 4 of the WHO Malaria RDT Product Testing Programme. The fact that certain products are not included in any list means that they have not or not yet been submitted for evaluation in the WHO Malaria RDT Product Testing Programme and does not indicate anything in respect of such products’ performance. WHO will not accept any liability or responsibility whatsoever for any injury, death, loss, damage, or other prejudice of any kind that may arise as a result of or in connection with the procurement, distribution and use of any product whatsoever included in this report. This report may not be used by manufacturers and suppliers for commercial or promotional purposes.
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) V
figUres
Figure S1: MalariaRDTperformanceinPhase2ofRounds1–4againstwild-type(clinical)samplescontainingP. falciparum atlow(200)andhigh(2000or5000)parasitedensities(parasites/µl)andclean-negativesamples
Figure S2: MalariaRDTperformanceinPhase2ofRounds1–4againstwild-type(clinical)samplescontainingP. vivax atlow(200)andhigh(2000or5000)parasitedensities(parasites/µl)andclean-negativesamples
Figure 1: Modeofactionofantigen-detectingmalariaRDTs
Figure 2: Networkofspecimencollection,characterizationandtestingsites
Figure 3: MalariaRDTProductTestingOverview
Figure 4a: OriginofPhase2P. falciparumwild-type(clinical)samples
Figure 4b: OriginofPhase2P. vivaxwild-type(clinical)samples
Figure 5: Testingprocedureandcalculationof‘paneldetectionscore’andbandintensityforProductAagainstasampledensityof200parasites/µl
Figure 6: Testingprocedureandcalculationof‘paneldetectionscore’andbandintensityforProductAagainstasampledensityof2000parasites/µl
Figure 7: Phase1P. falciparumpaneldetectionscoreofmalariaRDTsatlow(200)andhigh(2000)parasitedensities(parasites/µl)accordingtotargetantigentype(HRP2orpLDH)
Figure 8: Phase2P. falciparumpaneldetectionscoreofmalariaRDTsatlow(200)andhigh(2000)parasitedensity(parasites/µl)accordingtotargetantigentype(HRP2orpLDH)
Figure 9: Phase2P. vivaxpaneldetectionscoreofmalariaRDTsatlow(200)andhigh(2000)parasitedensities(parasites/µl)accordingtotargetantigentype(aldolase,pLDH)
Figure 10: Phase2P. falciparumpaneldetectionscoreandpositivityrateat200parasites/µl
Figure 11: Phase2P. vivaxpaneldetectionscoreandpositivityrateat200parasites/µl
Figure 12: Phase2P. falciparum(P. falciparumtestline)false-positiverateagainstclean-negativesamples
Figure 13: Phase2Plasmodiumspp.(panorP. vivax /Pvom testline)false-positiverateagainstclean-negativesamples
Figure 14: Phase2P. falciparumfalse-positiverateversusP. falciparumpaneldetectionscoreatlow(200)parasitedensity(parasites/µl)
Figure 15: Phase2P. vivaxfalse-positiverateversusP. vivaxpaneldetectionscoreatlow(200)parasitedensity(parasites/µl)
Figure 16: HeatstabilityofP. falciparum-specifictestlineofP. falciparum-onlytestsagainstalowdensityP. falciparumsample(200parasites/µl).Positivityrateatbaseline,andafter60daysincubation
Figure 17: HeatstabilityofP. falciparum-specifictestlineofP. falciparum-onlytestsagainstahighdensityP. falciparumsample(2000parasites/µl).Positivityrateatbaseline,andafter60daysincubation
Figure 18: HeatstabilityofP. falciparum-specifictestlineincombinationtestsagainstalowdensityP. falciparum sample(200parasites/µl).Positivityrateatbaseline,andafter60daysincubation
Figure 19: HeatstabilityofP. falciparumspecifictestlineincombinationtestsagainstahighdensityP. falciparum sample(2000parasites/µl).Positivityrateatbaseline,andafter60daysincubation
Figure 20: Heatstabilityofpan-lineofpan-specifictestsagainstalowdensityP. falciparumsample(200parasites/µl).Positivityrateatbaseline,andafter60daysincubation
Figure 21: Heatstabilityofpan-lineofpan-specifictestsagainstahighdensityP. falciparumsample(2000parasites/µl).Positivityrateatbaseline,andafter60daysincubation
Figure 22: Heatstabilityofpan-lineofcombinationtestsagainstalowdensityP. falciparumsample(200parasites/µl).Positivityrateatbaseline,andafter60daysincubation
Figure 23: Heatstabilityofpan-lineofcombinationtestsagainstahighdensityP. falciparumsample(2000parasites/µl).Positivityrateatbaseline,andafter60daysincubation
Figure A5.1: HowtoselectofanappropriateRDT
Figure A5.2: MalariaRDTanomaliesencounteredinproductionlots
Figure A6.1: ExampleofmalariaRDTimplementationstepsandtimeline
Figure A6.2: Componentsofthebudgetforamalariadiagnosisprogramme
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)VI
tables
Table S1: MalariaRDTPhase2performanceinRounds1–4againstwild-type(clinical)samplescontainingP. falciparum and P. vivax atlow(200)andhigh(2000or5000)parasitedensities(parasites/µl)andclean-negativesamples
Table S2: MalariaRDTRounds1–4heatstabilityresultsonacultured P. falciparum sampleatlow(200)andhigh(2000)parasitedensity(parasites/µl).Positivityrateatbaseline,andafter60daysincubationat35°Cand45°C
Table S3: Productresubmissions:WHOMalariaRDTProductTesting(Rounds1–4)
Table 1: ManufacturersandproductsacceptedintoRound4ofWHOMalariaRDTProductTestingProgramme
Table 2: CharacteristicsofPlasmodiumspp.negativespecimens
Table 3: SummaryPhase1performanceof48malariaRDTsagainst20culturedP. falciparumlinesatlow(200)andhigh(2000)parasitedensities(parasites/µl)
Table 4: SummaryPhase2performanceof46malariaRDTsagainstwild-type(clinical)P. falciparumandP. vivaxsamplesatlow(200)andhigh(2000)parasitedensities(parasites/µl)andPlasmodiumspp.negativesamples
Table 5: Heatstabilitytestingresultsfor46malariaRDTsonaculturedP. falciparumsampleatlow(200)andhigh(2000)parasitedensities(parasites/µl).Positivityrateatbaseline,andafter60daysincubationat35°Cand45°C
Table 6: Ease-of-usedescriptionof48malariaRDTs
Table A3.1: LotvariabilityinpositiveresultsagainstP. falciparumculturesamplesatlow(200)andhigh(2000or5000)parasitedensities(parasites/µl)
Table A3.2: Distributionoftestbandintensityscores(0–4)againstPhase1P. falciparumculturedparasitesatlow(200)andhigh(2000)parasitedensities(parasites/µl)
Table A4.1: LotvariabilityinpositiveresultsagainstPhase2wild-typeP. falciparumandP. vivaxsamplesatlow(200)andhigh(2000)parasitedensities(parasites/µl)
Table A4.2: Distributionoftestbandintensity(0–4)scoresagainstPhase2wild-typeP. falciparumsamplesatlow(200)andhigh(2000)parasitedensities(parasites/µl)
Table A4.3: DistributionofPan/Pvtestbandintensity(0–4)scoresforPhase2wild-typeP. vivaxsamplesatlow(200)andhigh(2000)parasitedensities(parasites/µl)
Table A4.4: PaneldetectionscoreofPhase2wild-typeP. falciparuminlow(200)andhigh(2000)parasitedensities(parasites/µl)bycontinent
Table A4.5: Phase2P. falciparumtestlinefalse-positiveratesforwild-typeP. vivaxsamplesatlow(200)andhigh(2000)parasitedensities(parasites/µl)
Table A4.6: Phase2Pan(orP. vivax)testlinefalse-positiveratefornon-Pfinfectiononwild-typeP. falciparumsamplesatlow(200)andhigh(2000)parasitedensities(parasites/µl)
Table A4.7: Phase2false-positiverateforP. falciparumtestlineresultsonallmalaria-negativesamples
Table A4.8: Phase2false-positiverateforP. falciparuminsamplescontainingspecificnon-malarialinfectiouspathogens
Table A4.9: Phase2false-positiverateforP. falciparuminsamplescontainingpotentiallycross-reactingbloodimmu-nologicalfactors
Table A4.10: Phase2false-positiverateforpan/P. vivax/Pvomtestlineresultsonallmalaria-negativesamples
Table A4.11: HeatstabilitytestingresultsforP. falciparum(orpan)testlineonaP. falciparumsampleatlowparasitedensity(200parasites/µl).Positivityrateatbaseline,andafter60daysincubationat4°C,35°Cand45°C
Table A4.11a: HeatstabilitytestingresultsforpantestlineofcombinationRDTsonaP. falciparumsampleatlowparasitedensity(200parasites/µl).Positivityrateatbaseline,andafter60daysincubationat4°C,35°Cand45°C
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) VII
Table A4.12: HeatstabilitytestingresultsforP. falciparum(orpan)testlineonaP. falciparumsampleathighparasitedensity(2000parasites/µl).Positivityrateatbaseline,andafter60daysincubationat4°C,35°Cand45°C
Table A4.12a: HeatstabilitytestingresultsforpantestlineofcombinationRDTsonaP. falciparumsampleathighparasitedensity(2000parasites/µl).Positivityrateatbaseline,andafter60daysincubationat4°C,35°Cand45°C
Table A4.13: HeatstabilitytestingresultsforP. falciparum(orpan)testlineonparasite-negativesamples.Positivityrateatbaseline,andafter60daysincubationat4°C,35°Cand45°C
Table A4.13a: HeatstabilitytestingresultsforpantestlineofcombinationRDTsonparasite-negativesamples.Positivityrateatbaseline,andafter60daysincubationat4°C,35°Cand45°C
Table A5.1 MalariaRDTfieldassessmentofpackaging,safetyandease-of-usetoguideproductselection
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)VIII
acknoWledgeMents
TheevaluationdescribedinthisreportwasajointprojectoftheWorldHealthOrganization(WHO)GlobalMalariaProgramme(GMP),theFoundationforInnovativeNewDiagnostics(FIND),theSpecialProgrammeforResearchandTraininginTropicalDiseasessponsoredbyUNICEF,UNDP,WorldBankandWHO(TDR)andtheUSCentersforDiseaseControlandPrevention(CDC),undertheWHO-FINDMalariaRDTEvaluationProgramme.TheprojectwasfinancedbyFIND,throughgrantsfromtheBillandMelindaGatesFoundation,theGlobalFundtofightAIDS,TuberculosisandMalaria,theUnitedStatesAgencyforInternationalDevelopment(USAID),andtheUKDepartmentforInternationalDevelopment(DFID),andbyTDR.Theprojectwouldnothavebeenpossiblewithoutthecooperationandsupportofthespecimencollectionsites,andthespecimencharacterizationlaboratoriesmentionedherein,andacknowledgesthetechnicaladvicefrommanymalariadiagnosticmanufacturersanddevelopersinthedevelopmentoftheprogramme.ThisreportonRound4ofWHOMalariaRDTProductTestingwascompiledbyJaneCunningham(WHO/GMP,Switzerland)andDavidBell(FoundationforInnovativeNewDiagnostics(FIND),Switzerland)
TheMalariaRDTEvaluationProgrammeofWHO,TDRandFINDisgratefultoallthosewhocontributedtotheconductoftheevaluationandpreparationofthisRound4report.
Salim Abdullah IfakaraHealthResearchandDevelopmentCentre,UnitedRepublicofTanzania
Yong Ah USCentersforDiseaseControlandPrevention/NationalCenterforGlobalHealth/DivisionofMalariaandParasiticDiseases,UnitedStatesofAmerica
Audrey Albertini FoundationforInnovativeNewDiagnostics(FIND),Switzerland
Frederic Ariey InstitutPasteur,Cambodia
John Barnwell USCentersforDiseaseControlandPrevention/NationalCenterforGlobalHealth/DivisionofMalariaandParasiticDiseases,UnitedStatesofAmerica
John Bligh HospitalforTropicalDiseases,UnitedKingdomofGreatBritainandNorthernIreland
David Bell FoundationforInnovativeNewDiagnostics(FIND),Switzerland
Andrea Bosman WorldHealthOrganization/GlobalMalariaProgramme,Geneva,Switzerland
Sandra Buisson HospitalforTropicalDiseases,UnitedKingdomofGreatBritainandNorthernIreland
Debora Casandra USCentersforDiseaseControlandPrevention/NationalCenterforGlobalHealth/DivisionofMalariaandParasiticDiseases,UnitedStatesofAmerica
Qin Cheng ArmyMalariaInstitute,Australia
Peter Chiodini HospitalforTropicalDiseases,UnitedKingdomofGreatBritainandNorthernIreland
Jane Cunningham TDR,SpecialProgrammeforResearchandTraininginTropicalDiseases,Switzerland
Chona Daga ResearchInstituteofTropicalMedicine,ThePhilippines
Linda Dantes WHO–RegionalOfficefortheWesternPacific,ThePhilippines
Djibrine Djalle InstitutPasteurBangui,CentralAfricanRepublic
Katie Downey USCentersforDiseaseControlandPrevention/NationalCenterforGlobalHealth/DivisionofMalariaandParasiticDiseases,UnitedStatesofAmerica
Babacar Faye UniversitéCheikhAntaDIOP,Senegal
Nahla Gadalla HospitalforTropicalDiseases,UnitedKingdomofGreatBritainandNorthernIreland
Dionicia Gamboa UniversidadPeruanaCayetanoHerediaInstitutodeMedicinaTropical,Peru
Cyrus Garay ResearchInstituteofTropicalMedicine,ThePhilippines
Michelle Gatton QueenslandInstituteofMedicalResearch,Australia
Jeffrey Glenn USCentersforDiseaseControlandPrevention/NationalCenterforGlobalHealth/DivisionofMalariaandParasiticDiseases,UnitedStatesofAmerica
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) IX
Iveth Gonzalez FoundationforInnovativeNewDiagnostics(FIND),Switzerland
Sandra Incardona FoundationforInnovativeNewDiagnostics(FIND),Switzerland
Cara Kosack MédecinsSansFrontières,TheNetherlands
Myat Phone Kyaw DepartmentofMedicalResearch,Myanmar
Jennifer Luchavez ResearchInstituteofTropicalMedicine,ThePhilippines
Lorraine Mationg ResearchInstituteofTropicalMedicine,ThePhilippines
James McCarthy QueenslandInstituteofMedicalResearch,UniversityofQueensland,Australia
Didier Menard InstitutPasteurdeMadagascar,Madagascar;InstitutPasteur,Cambodia
Claribel Murillo CentroInternacionaldeEntrenamientoeInvestigacionesMédicas(CIDEIM),Colombia
Sina Nhem InstitutPasteur/NationalMalariaCentre(CNM),Cambodia
Bernhards Ogutu KenyaMedicalResearchInstitute(KEMRI),Kenya
Pamela Onyor KenyaMedicalResearchInstitute(KEMRI),Kenya
Wellington Oyibo UniversityofLagos,Nigeria
Anita Pelecanos QueenslandInstituteofMedicalResearch,Australia
Mark Perkins FoundationforInnovativeNewDiagnostics(FIND),Switzerland
Roxanne Rees-Channer Consultant(FIND),HospitalforTropicalDiseases,UnitedKingdomofGreatBritainandNorthernIreland
Muth Sinuon NationalMalariaCentre(CNM),Cambodia
Man Somnang InstitutPasteur/NationalMalariaCentre(CNM),Cambodia
Julie Vercruysse FoundationforInnovativeNewDiagnostics(FIND),Switzerland
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)X
abbreViations
ACT Artemisinin-basedcombinationtherapy
AMI ArmyMalariaInstitute
CDC UnitedStatesCentersforDiseaseControlandPrevention
CLIA ClinicalLaboratoryImprovementAmendments
DFID UKDepartmentforOverseasDevelopment
FIND FoundationforInnovativeNewDiagnostics
FP False-positive
HRP2 Histidine-richprotein2
HTD HospitalforTropicalDiseases
ISO InternationalOrganizationforStandardization
PCR Polymerasechainreaction
PDS Paneldetectionscore
pLDH Plasmodiumlactatedehydrogenase
Pf Plasmodium falciparum
Pv Plasmodium vivax
Pvom Plasmodium vivax, ovale, malariae
PR Positivity rate
p/µL Parasitespermicrolitre
QA Qualityassurance
QC Qualitycontrol
QMS Qualitymanagementsystems
RDT Rapiddiagnostictest(forthepurposesofthisreport,thisreferstoimmunochromatographiclateralflowdevicesforthedetectionofmalariaparasiteantigens)
SOP StandardOperatingProcedure
TDR SpecialProgrammeforResearchandTraininginTropicalDiseasessponsoredbyUNICEF,UNDP,WorldBankandWHO
UN UnitedNations
USA UnitedStatesofAmerica
USAID UnitedStatesAgencyforInternationalDevelopment
WPRO WesternPacificRegionalOffice
WHO WorldHealthOrganization
sUM
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1Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
1. sUMMarY perforMance of Malaria rdts: WHo prodUct testing: roUnds 1–4
1.1. introductionTheWorldHealthOrganizationestimatesthathalftheworld’spopulationisatriskofmalaria,withanestimated216millionpeople(range149–274million)developingclinicalmalaria in2010(81%inAfrica),and655,000deaths(range537,000–907,000)duetomalaria(91%inAfrica,mostbeingchildren).Malariaremainsendemicin106countries,andwhileparasite-baseddiagnosisisincreasing,mostsuspectedcasesofmalariaarestillnotproperlyconfirmed,resultinginover-useofanti-malarialdrugsandpoordiseasemonitoring1.
WHOrecommendsthatmalariacasemanagementbebasedonparasite-baseddiagnosisinallcases2.Theuseofantigen-detectingrapiddiagnostictests(RDTs)formsavitalpartofthisstrategy,formingthebackboneofexpansionofaccesstomalariadiagnosisbyprovidingparasite-baseddiagnosisinareaswheregoodqualitymicroscopycannotbemaintained.ThenumberofRDTsavailable,andthescaleoftheiruse,hasrapidlyincreasedoverthepastfewyears.However,limitationsofcomparativefieldtrialsandtheheterogeneousnatureofmalariatransmissionandepidemiologyhaslimitedtheavailabilityofgoodqualityperformancedatathatnationalmalariaprogrammesrequiretomakeinformeddecisionsonprocurementandimplementation,andlimitstheabilitytoextrapolateresultsoffieldtrialstodifferentpopulationsandtimeperiods.Tothisend,in2006,theWorldHealthOrganization(WHO),SpecialProgrammeforResearchandTraininginTropicalDiseases(TDR)andtheFoundationforInnovativeNewDiagnostics(FIND)launchedanevalua-tionprogrammetoassessthecomparativeperformanceofcommerciallyavailablemalariaRDTs.Currently,thesedataareguidingprocurementdecisionswhichareinturnshiftingmarketstowardsbetter-performingtests1andhelpingtodriveoverallimprovementinthequalityofmanufacturing.TheresultsofWHOMalariaRDTProductTestinghavebeenpublishedannuallysince2009andformthebasisofprocurementcriteriaofWHO,otherUNagencies,theGlobalFundandnationalgovernments.
ThisSummarypresentsanoverviewoftheresultsofthefirstthroughfourthroundsofWHOMalariaRDTProductTestingandispublishedinconjunctionwiththereleaseofthefullreportonRound4.Theresultsofthefourroundsoftestingshouldbeconsideredasasingledataset.Separate
1 World Malaria Report 2011.Geneva,WorldHealthOrganization,20112 Guidelines for the Treatment of Malaria, Second Edition.Geneva,
WorldHealthOrganization,2010(ISBN9789241547925)
fullreportsofallroundsshouldbeconsultedforfurtherdetailonproductperformance,andontheinterpretationanduseoftheseresults.
1.2. the WHo product testing programmeTheRDTevaluationssummarizedherewereperformedasacollaborationbetweenWHO,TDR,FIND,theUSCentersforDiseaseControlandPrevention(CDC)andotherpartners3.AllcompaniesmanufacturingunderISO13485:2003QualitySystemStandardwereinvitedtosubmitalimitednumberofproducts(2–3)forevaluationundertheprogramme.Inthefirstroundoftesting,41productsfrom21manufacturerswereevaluatedagainstpreparedbloodpanelsofculturedPlasmodium falciparumparasites,while29,50and48productsfrom13,23and27manufacturerswereevaluatedinRound2,3and4,respectively.Manymanufacturershavedecidedtovoluntarilyre-submitproductstooneormoreroundsoftesting,including1,23and13resubmissionsinRound2,3and4,respectively(TableS3).Ofthese168totalproducts,164progressedtotestingagainstpanelsofpatient-derivedP. falciparumandP. vivaxparasites,andaparasite-negativepanel.Thermalstabilitywasassessedaftertwomonthsofstorageatelevatedtemperatureandhumidity,andadescriptiveease-of-useassessmentwasrecorded.Ofthe164fullyevaluatedproducts,21havebeenevaluatedtwice,and8havebeenevaluatedthreetimesbetweenRounds1-4.Ofthe128uniqueproductstestedbytheprogramme,35detectP. falciparumalone,83detectanddifferentiateP. falciparumfromnon-P. falciparummalaria(eitherpan-specificorspecies-specific(Pv,Pvom),9detectP. falciparumandnon-P. falciparummalariawithoutdistinguishingbetweenthem,andoneproductwasdesignedtodetectP. vivaxonly.Manufacturerssubmittedtwolotsofeachproductforevaluation.Wherethesameproducts4havebeenre-submittedinsubsequentroundsoftesting,thelatterresultsreplacethosepublishedfromtheearlierround.Thus,theperformanceofmanytestsintheresultsbelowdifferfromthosepublishedintheRounds1–3reports.
Theevaluationisdesignedtoprovidecomparativedataontheperformanceofthesubmittedproductionlotsofeachproduct.SuchdatawillbeusedtoguideprocurementdecisionsofWHOandotherUNagenciesandnationalgovernments.
3 SeefullreportsofRounds1–4forfulllistofcollaboratingpartners.4 Informal Consultation on Laboratory Methods for Quality Assurance
of Malaria Rapid Diagnostic Tests.20-22July2004.Manila.WHORegionalOfficefortheWesternPacific.2004.(RS/2004/GE/26(PHL)
2 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
ProducttestingispartofacontinuingprogrammeofworktoimprovethequalityofRDTsthatareused,andtosupportbroadimplementationofreliablemalariadiagnosisinareaswheremalariaisprevalent.AfifthroundofproducttestingwillbegininJanuary2013.
1.3. results of the evaluationTheresults(summarizedinFiguresS1andS2andTablesS1andS2)providecomparativedataontwolotsofproductsagainstapanelofparasitesamplesdilutedtoalowparasitedensity(200parasites/µl)andahigherparasitedensity(2000or5000parasites/µl).Theformeriswellbelowthemeanparasitedensityfoundinmanypopulationswithendemicmalaria,andconsideredclosetothethresholdthattestsmustdetecttoreliablyidentifyclinicalmalariainmanysettings1.Forthepurposesofthisreport,themainmeasureofperform-anceisthe‘paneldetectionscore(PDS)’2;thepercentageofmalariasamplesinthepanelgivingapositiveresultbytwoRDTsperlotatthelowerparasitedensity,andasingleRDTperlotatthehigherparasitedensity.Thus,itisnotameasureofRDTclinicalsensitivity,orpositivityrateagainstthepanelbutratheracombinedmeasureofpositivityrate,alongwithinter-testandinter-lotconsistency.Thefiguresalsoshowthefalse-positiveratesagainstbloodsamplescontainingnomalariaparasitesorknownmarkersofotherdiseases,andtherateatwhichinvalidresultsoccurred.
TheclinicalsensitivityofaRDTtodetectmalariaishighlydependentonthelocalconditions,includingparasitedensityinthetargetpopulation.Sensitivityofatestwillthereforevaryamongpopulationswithdifferinglevelsoftransmis-sion,astheirdifferentlevelsofimmunityaffectthepara-sitedensityatwhichtheyexhibitsymptomswarrantingadiagnostictest.Wheretransmissionratesarelow,parasitedensitiesinpeoplewithsymptomsofmalariaarelikelytobelower,resultingintestshavingalowersensitivity.Forthisreason,testperformanceat200parasites/µlisparticularlyimportant.TheresultsinthisreportshowcomparativeperformanceamongRDTs,andgiveanindicationofwhichproductsarelikelytoprovidehighersensitivityinthefield,particularlyinpopulationswithlow-densityinfections.
Ingeneral,ascountriesreducemalariaprevalenceandevenmovetowardsmalariaelimination,detectionoflowparasitedensitiesbecomesincreasinglyimportantincasemanage-ment.Asthedetectionrateat2000parasites/µlindicates,thesensitivityofmanyoftheseproductswillbesimilarinpopulationswithhigherparasitedensities,althoughasubsetofanypopulationwillincludevulnerableindividualswhomaydevelopillnessatlowparasitedensities(e.g.youngchildren,pregnantwomen,thosewellprotectedbybednets)andmustalwaysbetakenintoaccountwheninterpretingRDTresults.AnimportantcaveatwhenpredictingfieldsensitivityfromthePDSprovidedinthisreportisthatthepanelsusedinthis
1 Parasitological Confirmation of Malaria Diagnosis. ReportofaWHOtechnicalconsultationGeneva,6–8October2009. Geneva,WorldHealthOrganization,2010.(ISBN9789241599412)
2 Termed‘DetectionRate’inthefullreportofRound1,publishedin2009.SeetheRound4reportforafullexplanationofthepaneldetectionscore(PDS).
evaluationonlyincludeparasitesknowntoexpressthetargetantigens.Whilenon-expressionofthetargetantigenshasnotbeenrecordedforaldolaseorpLDH,itisknownthatparasitesinfectingpeopleinsomeareasofSouthAmericadonotexpressHRP23.InareaswhereHRP2-deletedparasitesexist,HRP2-detectingtestswillhavegreatlyreducedsensitivityorbeincapableofdetectingP. falciparum.Insuchpopulations,onlytestsdetectingpLDHinP. falciparumparasiteswillbeeffectiveindiagnosingfalciparummalaria.
Heatstability(summarizedinTableS2)isvitaltomaintainingsensitivityofthetestinthefield.Asaresult,forprocurement,itisessentialthatcarefulconsiderationbegiventostabilityresultstoensurethatproductstobeusedinareaswithhightemperaturesoftransportandstoragehavedemonstratedstabilityintheproducttestingprogramme.Requirementswillvarybetweencountries:forexample,iftestsaretobedeployedinareaswheretemperaturesrarelyriseabove30°C,lessemphasismaybeplacedonstabilityathightemperaturescomparedtootheraspectsoftestquality.
Ease-of-userequirementswillalsovary,dependingontheextentoftrainingandtheworkenvironmentoftheend-users.Particularlyinprimaryhealthcaresettings,thesimplerthetests,theeasieritwillbetoavoiderrorsinpreparationandinterpretation.
Detailedresultsoftheevaluationscanbefoundinthereportsofeachevaluation,4andatwww.wpro.who.int/sites/rdt.WHOprovidesguidanceontheprocurementandimplementationofmalariaRDTs5,6.Furthermore,aninteractiveguidetoassistinselectingproductswithperformancecharacteristicsmostsuitableforaparticularcountryhealthprogrammeisfoundontheFINDwebsite.7
3 Gamboa,D.,M.F.Ho,etal. A large proportion of P. falciparum isolates in the Amazon region of Peru lack pfhrp2 and pfhrp3: implications for malaria rapid diagnostic tests. PLoS One,2010:5(1):e8091.
4 Malaria Rapid Diagnostic Test Performance : Results of WHO product testing of malaria RDTs: Round 1 (2008).Geneva,WorldHealthOrganization,2009.ISBN9789241598071;Malaria Rapid Diagnostic Test Performance : Results of WHO product testing of malaria RDTs: Round 2 (2009). Geneva,WorldHealthOrganization,2010.ISBN9789241599467;Malaria Rapid Diagnostic Test Performance : Results of WHO product testing of malaria RDTs: Round 3 (2010-11).Geneva,WorldHealthOrganization,2011.ISBN9789241502566.
5 Good practices for selecting and procuring rapid diagnostic tests for malaria.Geneva,WorldHealthOrganization , 2011(ISBN9789241501125)
6 Universal Access to Malaria Diagnostic Testing: An operational manual.Geneva,WorldHealthOrganization,2011(ISBN978924150209)
7 MalariaRDTInteractiveGuide:http://www.finddiagnostics.org/programs/malaria-afs/malaria/rdt_quality_control/product_testing/interactive-guide/index.jsp
sUM
Mar
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4
3Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
1.4. summary of outcomesThislaboratory-basedevaluationprovidesacomparativemeasureofRDTperformanceinastandardizedwaytodistinguishbetweenwellandpoorlyperformingteststoinformprocurementdecisionsofmalariacontrolprogrammesandguideUNprocurementpolicy.
Overall,thegainsnotedintheperformanceofproductsre-submittedtoRound3wereseenagaininRound4forseveralproducts(TableS3),indicatingproductimprovementbythemanufacturers.Furthermore,inRound4thepropor-tionoftestsachievingaPDS(>75%)at200parasites/µliscomparabletoRound3forP. falciparumat73.9%andforP. vivax,theproportionis47.2%,representinganimprove-mentoverRounds1and3combined(36.7%).
SeveralRDTsfromthefourroundsoftestingdemonstratedconsistentdetectionofmalariaatlowparasitedensities(200parasites/µl),havelowfalse-positiverates,arestableattropicaltemperatures,arerelativelyeasytouse,andcandetectP. falciparum,P. vivaxinfections,orboth.
Performanceamongproductsvariedwidelyatlowparasitedensity(200parasites/µl);however,themajorityofproductsshowedahighlevelofdetectionat2000or5000parasites/µl.
P. falciparumteststargetingHRP2antigendemonstratedthehighestdetectionrates.InRound4,bothteststargetingpf-pLDHfordetectionofP. falciparuminfectiondidnotpassPhase1.Thus,therangeofchoiceforwell-performingpLDHbasedP. falciparumtestsremainslimited,asitdoesforpan-onlyspecifictests.
Testperformancesometimesvariedbetweenlots,andwidelybetweensimilarproducts,confirmingtheadvisabilityoflot-testingpost-purchaseandpriortouseinthefield.
Theresultsunderscoretheneedformanufacturerstohaveadequatereferencematerialsforproductdevelopmentandlot-release.TheWHO-FINDMalariaRDTEvaluationProgramme,incollaborationwiththeCDC,offersqualitystandardpanelsofP. falciparumisolatestomanufacturerstoassistinthisprocessandisplanningtotransitiontomalariarecombinantantigenspanelsbytheendof2014.
1.5. Use of these resultsAccuratediagnosisisvitaltogoodmalariacasemanagement,whetherbasedonmicroscopyorRDTs.Theresultsofthisreportshouldbeusedtoshort-listRDTsforprocurementforuseinsettingswheregoodmicroscopyisnotavailableorappropriate.Additionally,itisimperativethatprocurementdecisionsbasedontheseresultstakeintoconsiderationlocalconditionsofmalariatransmissionandillnesswherethetestswillbeused(e.g.Plasmodiumspecies,targetantigenvaria-tion,parasitedensities,climate),aswellasotherimportantconsiderations,includingfield-basedease-of-useassess-ments,andtraining/retrainingrequirements.Furthermore,inordertoensurethatthehighperformancedemonstratedbythelotsevaluatedintheproducttestingprogrammeismaintained,itisrecommendedthateachlotofRDTsisalsotestedinastandardizedwaypriortodispersaltothefield1.ProcurementofRDTsmustnotoccurwithoutprogrammaticandinfrastructurepreparationforproperuse,includingsupplychainmanagement,trainingontestusageanddisposal,andtrainingonpatientmanagementinresponsetoresults.Themainreportprovidesanalgorithm(Annex5a)toassistinthisdecision-makingprocessandcomprehensiveguidanceonseveralaspectsofprocurementcanbefoundin‘Good Practices for selecting and procuring rapid diagnostic tests for malaria’2.
1 TheWHO-FINDMalariaRDTEvaluationProgrammeprovideslot-testingcapacityinanumberofregionallaboratoriesfreeofcharge,[email protected]@finddiagnostics.org.
2 Good Practices for selecting and procuring rapid diagnostic tests for malaria, Geneva, World Health Organization, 2011(ISBN9789241501125)
4 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Figure S1: Malaria RDT performance in Phase 2 of Rounds 1-4 against wild type (clinical) samples containing P. falciparum at low (200) and high (2000–5000) parasite densities (parasites/µl) and clean-negative samples
a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive. b Clean-negative - blood samples from healthy volunteers with no known current illness or blood abnormality. * Indicates tests that also detect other non-P. falciparum parasites
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5Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Figure S1: Malaria RDT performance in Phase 2 of Rounds 1-4 against wild type (clinical) samples containing P. falciparum at low (200) and high (2000–5000) parasite densities (parasites/µl) and clean-negative samples
a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive. b Clean-negative - blood samples from healthy volunteers with no known current illness or blood abnormality. * Indicates tests that also detect other non-P. falciparum parasites
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6 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Figure S2: Malaria RDT performance in Phase 2 of Rounds 1-4 against wild type (clinical) samples containing P. vivax at low (200) and high (2000–5000) parasite densities (parasites/µl)) and clean-negative samples
a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive. b Clean-negative - blood samples from healthy volunteers with no known current illness or blood abnormality.
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01
02
5F
irst
Sig
n™
- P
araV
iew
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an+
Pf)
Mal
aria
Tes
t 2
10
1C
B-2
5P
araH
IT -
To
tal V
er.
1.0
(D
ipst
ick)
55
IC2
03
-10
IND
ON
E S
TE
P M
AL
AR
IA A
NT
IGE
N P
.f/P
an T
ES
T 5
35
-10
ICT
Dia
gn
ost
ics
Mal
aria
Du
al
ML
03
Co
re™
M
alar
ia P
v/P
f M
AL
-19
00
22
Mal
asca
n™
Dev
ice
- R
apid
tes
t fo
r M
alar
ia P
f/P
an
50
40
20
25
dia
gn
ost
icks
MA
LA
RIA
(P
an)
Cas
sett
e M
PN
WB
C1
00
7.3
dia
gn
ost
icks
MA
LA
RIA
(P
an/P
f) C
asse
tte
MP
NF
WB
C1
00
7.4
On
Sig
ht™
Par
aQu
ick
(Pan
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f) T
est
53
6-2
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BC
lear
view
® M
alar
ia D
ual
Tes
t D
evic
e V
B2
0d
iag
no
stic
ks-
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aria
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f) C
asse
tte
KM
VF
C6
00
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irst
Sig
n™
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araV
iew
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v+P
f) M
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ia T
est
21
03
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-25
Par
amax
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apid
Tes
t fo
r M
alar
ia P
an/P
v/P
f (d
evic
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03
20
02
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ust
y™ M
alar
ia A
nti
gen
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./p
.v.
test
A0
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2-3
22
On
Sig
ht™
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araQ
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v,P
f) M
alar
ia T
est
53
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BA
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nta
ge
Mal
aria
Car
d
IR2
11
02
5Im
mu
no
qu
ick
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aria
+4
05
06
_K2
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ore
Mal
aria
Pan
Pf
MA
L-1
90
02
4P
aras
cree
n®
Dev
ice
- R
apid
tes
t f
or
Mal
aria
Pan
/Pf
50
31
00
25
IMM
UN
OQ
UIC
K C
ON
TAC
T M
AL
AR
IA +
4
05
25
K2
5H
iSen
s M
alar
ia A
g P
.f/P
.v C
ard
H
R2
82
3E
zDx™
Mal
aria
Pan
/Pf
Rap
id T
est
Det
ecti
on
kit
RK
MA
L 0
01
Co
re™
M
alar
ia P
an/P
v/P
f M
AL
-19
00
26
dia
gn
ost
icks
MA
LA
RIA
(P
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v/P
f) C
asse
tte
MP
NV
FC
10
07
.5P
araH
IT®
to
tal (
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stic
k) 5
5IC
20
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0B
inax
No
w
Mal
aria
Tes
t IN
66
00
50
Nan
oS
ign
Mal
aria
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Pv
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RM
AD
10
AB
ON
™ P
lus
Mal
aria
P.f
/Pan
Rap
id T
est
Dev
ice
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ole
Blo
od
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A-T
40
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T M
alar
ia C
om
bo
M
L0
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alar
ia p
f (p
LD
H)
/ P
AN
-pL
DH
Tes
t D
evic
e
MF
V-1
24
Cle
arvi
ew®
Mal
aria
Co
mb
o V
B1
1M
alar
ia P
f/ P
AN
GM
00
4M
alar
ia p
f (H
RP
II)/
PA
N (
pL
DH
) A
nti
gen
Det
ecti
on
Tes
t D
evic
e 1
-13
-10
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MeD
iPro
Mal
aria
Ag
HR
P2
/pL
DH
Co
mb
o I
R-0
05
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Su
rest
ep™
Eas
y M
alar
ia P
f/P
an R
apid
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t D
evic
e I
MA
-T4
02
Mal
aria
pf
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P I
I) /
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N-p
LD
H)
An
tig
en D
etec
tio
n T
est
Dev
ice
M
FV
-12
4R
On
e S
tep
Mal
aria
P.F
/P.V
Tes
t (C
asse
tte)
52
33
52
AZ
OG
Mal
aria
pf
(HR
PII)
/pf
(LD
H)/
(P
AN
-LD
H)
An
tig
en D
etec
tio
n D
evic
e M
FV
-12
4F
Fir
stS
ign
™ -
Par
aVie
w-2
(P
v +
Pf)
Car
d T
est
21
02
CB
-25
Mal
eris
can
® M
alar
ia P
.f/P
AN
(P
v, P
m,
Po
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Lin
e A
nti
gen
Tes
t M
AT-
PF
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N-5
0A
BO
N M
alar
ia P
an/P
.f.
Rap
id T
est
Dev
ice
IM
A-B
40
2M
aler
isca
n®
Mal
aria
Pf/
Pv
MA
T-5
0O
ne
Ste
p M
alar
ia A
nti
gen
Str
ip 8
20
-1Q
uic
ksti
ck M
alar
ia A
nti
gen
Tes
tA
ZO
G
hC
G M
alar
ia D
etec
tio
n T
est
Dev
ice
MP
T-1
24
Par
ahit
-To
tal D
evic
e R
apid
tes
t fo
r P.
fal
cip
aru
m a
nd
Pan
mal
aria
l sp
ecie
s. 2
59
89
Hex
ago
n M
alar
ia C
om
bi 5
80
24
Mal
aria
Pan
Tes
t M
AL
-W2
3N
-00
1M
alar
ia P
.F/V
ivax
17
21
1O
P-2
5M
alar
ia p
f (H
RP
II)
/ p
v (p
LD
H)
An
tig
en D
etec
tio
n T
est
Dev
ice
1-1
3-1
01
-3M
alar
ia p
f (H
RP
II)
/ p
v (p
LD
H)
An
tig
en D
etec
tio
n T
est
Dev
ice
MF
V-1
24
VM
alar
ia P
f/P
v G
M0
02
Ad
van
ced
Qu
alit
y™
On
e S
tep
Mal
aria
P.f
/P.v
Tri
-Lin
e Te
st
ITP
11
00
3 T
C4
0H
um
asis
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aria
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/Pan
An
tig
en T
est
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AL
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25
sUM
Mar
Y r
oU
nd
s 1-
4
7Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Figure S2: Malaria RDT performance in Phase 2 of Rounds 1-4 against wild type (clinical) samples containing P. vivax at low (200) and high (2000–5000) parasite densities (parasites/µl)) and clean-negative samples
a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive. b Clean-negative - blood samples from healthy volunteers with no known current illness or blood abnormality.
Hu
mas
is M
alar
ia P
.f/P
.v A
nti
gen
Tes
t A
MF
V-7
02
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nS
ite
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id T
est
R0
11
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van
tag
e P
an M
alar
ia C
ard
IR
01
30
25
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van
tag
e M
al C
ard
IR
22
10
25
Car
eSta
rt™
Mal
aria
pL
DH
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AN
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01
11
SD
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LIN
E M
alar
ia A
g
05
FK
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SD
BIO
LIN
E M
alar
ia A
g P
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an
05
FK
60
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NO
TE
MA
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RIA
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.& P
.v.
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id T
est
Kit
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G1
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pti
MA
L-I
T
71
00
24
Nan
oS
ign
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aria
Pf/
Pan
Ag
3.0
RM
AP
10
SD
BIO
LIN
E M
alar
ia A
g P
f/ P
f/ P
v 0
5F
K1
00
SD
BIO
LIN
E M
alar
ia A
g P
f/P
v 0
5F
K8
0C
areS
tart
™
Mal
aria
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gn
ancy
Co
mb
o (
pL
DH
/HR
P2
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G)
GO
22
1C
areS
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aria
HR
P2
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f/P
v) C
OM
BO
G0
16
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edis
enso
r M
alar
ia H
RP
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LD
H (
Pf/
Pv)
CO
MB
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16
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araC
are
Mal
aria
HR
P2
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DH
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f/P
v) C
OM
BO
G0
16
1S
D B
IOL
INE
Mal
aria
Ag
Pf/
Pan
05
FK
66
Fir
st R
esp
on
se®
Mal
aria
Ag
pL
DH
I1
2F
RC
30
SD
BIO
LIN
E M
alar
ia A
g P
v 0
5F
K7
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™ M
alar
ia p
LD
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e Te
st
GO
12
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areS
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™ M
alar
ia H
RP
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LD
H (
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M)
CO
MB
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71
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isen
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aria
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OM
BO
M1
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aCar
e M
alar
ia H
RP
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H (
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CO
MB
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01
71
Car
eSta
rt™
Mal
aria
HR
P2
/pL
DH
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f/P
AN
) C
OM
BO
G0
13
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areS
tart
™ M
alar
ia S
cree
n
GO
23
1B
ION
OT
E M
AL
AR
IA P
.f.&
Pan
Ag
Rap
id T
est
Kit
R
G1
9-0
8F
alci
vax™
Rap
id T
est
for
Mal
aria
Pv/
Pf
50
30
00
25
On
Sit
e P
f/P
an A
g R
apid
Tes
t R
01
13
CO
ne
Ste
p M
alar
ia P
.f/P
an T
est
W
56
-CC
lear
view
® M
alar
ia p
LD
H 7
08
84
02
5F
irst
Sig
n™
- P
anC
hec
k (P
an)
Mal
aria
Tes
t 2
10
4 C
B-2
5P
araH
IT -
To
tal V
er.
1.0
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evic
e) 5
5IC
20
4-1
0R
AP
ID 1
-2-3
® H
EM
A C
AS
SE
TTE
MA
LAR
IA P
F/P
V T
ES
T M
AL-
PFV
-CA
S/2
5(10
0)H
iSen
s M
alar
ia A
g P
.f/P
.v C
om
bo
Car
d H
R3
12
3O
nS
igh
t™ -
Pan
Scr
een
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an)
Mal
aria
Tes
t 5
39
-25
-DB
HiS
ens
Mal
aria
Ag
P.f
/VO
M C
om
bo
Car
d H
R3
32
3F
irst
Res
po
nse
® M
alar
ia p
LD
H/H
RP
2 C
om
bo
Tes
t I1
6F
RC
30
HiS
ens
Mal
aria
Ag
Pf/
Pv
(HR
P2
/pL
DH
) C
ard
HR
29
23
Par
aban
k™ D
evic
e -
Rap
id t
est
for
Mal
aria
Pan
5
03
01
02
5F
irst
Sig
n™
- P
araV
iew
(P
an+
Pf)
Mal
aria
Tes
t 2
10
1C
B-2
5P
araH
IT -
To
tal V
er.
1.0
(D
ipst
ick)
55
IC2
03
-10
IND
ON
E S
TE
P M
AL
AR
IA A
NT
IGE
N P
.f/P
an T
ES
T 5
35
-10
ICT
Dia
gn
ost
ics
Mal
aria
Du
al
ML
03
Co
re™
M
alar
ia P
v/P
f M
AL
-19
00
22
Mal
asca
n™
Dev
ice
- R
apid
tes
t fo
r M
alar
ia P
f/P
an
50
40
20
25
dia
gn
ost
icks
MA
LA
RIA
(P
an)
Cas
sett
e M
PN
WB
C1
00
7.3
dia
gn
ost
icks
MA
LA
RIA
(P
an/P
f) C
asse
tte
MP
NF
WB
C1
00
7.4
On
Sig
ht™
Par
aQu
ick
(Pan
, P
f) T
est
53
6-2
5D
BC
lear
view
® M
alar
ia D
ual
Tes
t D
evic
e V
B2
0d
iag
no
stic
ks-
Mal
aria
(P
v/P
f) C
asse
tte
KM
VF
C6
00
2F
irst
Sig
n™
- P
araV
iew
-3 (
Pan
+P
v+P
f) M
alar
ia T
est
21
03
CB
-25
Par
amax
-3 R
apid
Tes
t fo
r M
alar
ia P
an/P
v/P
f (d
evic
e) 5
03
20
02
5Tr
ust
y™ M
alar
ia A
nti
gen
P.f
./p
.v.
test
A0
3-1
2-3
22
On
Sig
ht™
- P
araQ
uic
k-2
(P
v,P
f) M
alar
ia T
est
53
7-2
5-D
BA
dva
nta
ge
Mal
aria
Car
d
IR2
11
02
5Im
mu
no
qu
ick
Mal
aria
+4
05
06
_K2
5C
ore
Mal
aria
Pan
Pf
MA
L-1
90
02
4P
aras
cree
n®
Dev
ice
- R
apid
tes
t f
or
Mal
aria
Pan
/Pf
50
31
00
25
IMM
UN
OQ
UIC
K C
ON
TAC
T M
AL
AR
IA +
4
05
25
K2
5H
iSen
s M
alar
ia A
g P
.f/P
.v C
ard
H
R2
82
3E
zDx™
Mal
aria
Pan
/Pf
Rap
id T
est
Det
ecti
on
kit
RK
MA
L 0
01
Co
re™
M
alar
ia P
an/P
v/P
f M
AL
-19
00
26
dia
gn
ost
icks
MA
LA
RIA
(P
an/P
v/P
f) C
asse
tte
MP
NV
FC
10
07
.5P
araH
IT®
to
tal (
dip
stic
k) 5
5IC
20
1-1
0B
inax
No
w
Mal
aria
Tes
t IN
66
00
50
Nan
oS
ign
Mal
aria
Pf/
Pv
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RM
AD
10
AB
ON
™ P
lus
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aria
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/Pan
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id T
est
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ice
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ole
Blo
od
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A-T
40
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T M
alar
ia C
om
bo
M
L0
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alar
ia p
f (p
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/ P
AN
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t D
evic
e
MF
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24
Cle
arvi
ew®
Mal
aria
Co
mb
o V
B1
1M
alar
ia P
f/ P
AN
GM
00
4M
alar
ia p
f (H
RP
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PA
N (
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DH
) A
nti
gen
Det
ecti
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Tes
t D
evic
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-13
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MeD
iPro
Mal
aria
Ag
HR
P2
/pL
DH
Co
mb
o I
R-0
05
1K
Su
rest
ep™
Eas
y M
alar
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f/P
an R
apid
Tes
t D
evic
e I
MA
-T4
02
Mal
aria
pf
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P I
I) /
(PA
N-p
LD
H)
An
tig
en D
etec
tio
n T
est
Dev
ice
M
FV
-12
4R
On
e S
tep
Mal
aria
P.F
/P.V
Tes
t (C
asse
tte)
52
33
52
AZ
OG
Mal
aria
pf
(HR
PII)
/pf
(LD
H)/
(P
AN
-LD
H)
An
tig
en D
etec
tio
n D
evic
e M
FV
-12
4F
Fir
stS
ign
™ -
Par
aVie
w-2
(P
v +
Pf)
Car
d T
est
21
02
CB
-25
Mal
eris
can
® M
alar
ia P
.f/P
AN
(P
v, P
m,
Po
) 3
Lin
e A
nti
gen
Tes
t M
AT-
PF
/PA
N-5
0A
BO
N M
alar
ia P
an/P
.f.
Rap
id T
est
Dev
ice
IM
A-B
40
2M
aler
isca
n®
Mal
aria
Pf/
Pv
MA
T-5
0O
ne
Ste
p M
alar
ia A
nti
gen
Str
ip 8
20
-1Q
uic
ksti
ck M
alar
ia A
nti
gen
Tes
tA
ZO
G
hC
G M
alar
ia D
etec
tio
n T
est
Dev
ice
MP
T-1
24
Par
ahit
-To
tal D
evic
e R
apid
tes
t fo
r P.
fal
cip
aru
m a
nd
Pan
mal
aria
l sp
ecie
s. 2
59
89
Hex
ago
n M
alar
ia C
om
bi 5
80
24
Mal
aria
Pan
Tes
t M
AL
-W2
3N
-00
1M
alar
ia P
.F/V
ivax
17
21
1O
P-2
5M
alar
ia p
f (H
RP
II)
/ p
v (p
LD
H)
An
tig
en D
etec
tio
n T
est
Dev
ice
1-1
3-1
01
-3M
alar
ia p
f (H
RP
II)
/ p
v (p
LD
H)
An
tig
en D
etec
tio
n T
est
Dev
ice
MF
V-1
24
VM
alar
ia P
f/P
v G
M0
02
Ad
van
ced
Qu
alit
y™
On
e S
tep
Mal
aria
P.f
/P.v
Tri
-Lin
e Te
st
ITP
11
00
3 T
C4
0H
um
asis
Mal
aria
P.f
/Pan
An
tig
en T
est
AM
AL
-70
25
200 parasites/µl2000 parasites/µlFalse-positive Plasmodium spp. rate (%)Invalid rate (%)
8 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Tabl
e S1
: Mal
aria
RDT
Pha
se 2
per
form
ance
in R
ound
s 1–
4 ag
ains
t w
ild t
ype
(clin
ical
) sa
mpl
es c
onta
inin
g P.
fal
cipa
rum
and
P. v
ivax
at
low
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a •
Gese
llsch
aft f
ür D
iagn
ostik
a m
bH54
.60.
097
.048
.62.
815
.70.
017
.144
.00.
03
Mal
aria
pf (
HRP
II) /
(PAN
-pLD
H) A
ntig
en D
etec
tion
Test
Dev
icej
MFV
-124
RAZ
OG, I
nc.
95.0
0.0
100.
094
.30.
0 (3
95)
7.9
8.1
0.0
5.5
(199
)0.
33
Mal
aria
pf (
HRP
II)/P
AN (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e1-
13-1
01-1
Uni
ted
Biot
ech,
Inc.
63
.32.
910
0.0
85.3
0.0
0.0
(135
)0.
00.
00.
00.
14
Mal
aria
pf (
pLDH
) / P
AN-p
LDH
Tes
t Dev
ice
M
FV-1
24AZ
OG, I
nc.
2.0
5.7
70.7
97.1
0.0
(394
)0.
0 (1
39)
0.0
0.0
0.0
(198
)0.
43
Mal
aria
Pf/
PAN
GM
004
Geno
mix
Mol
ecul
ar D
iagn
ostic
s Pvt
.Ltd.
39.8
2.9
94.9
97.1
0.3
0.7
0.0
0.0
0.0
0.0
4M
alas
can™
Dev
ice
- Ra
pid
test
for M
alar
ia P
f/Pa
nj 50
4020
25Ze
phyr
Bio
med
ical
Sys
tem
s82
.857
.197
.010
0.0
1.0
(392
)0.
7 (1
36)
1.0
(194
)0.
0 (6
8)1.
0 (1
95)
1.9
3M
aler
isca
n® M
alar
ia P
.f/PA
N (P
v, Pm
, Po)
3 L
ine
Antig
en T
est
MAT
-PF/
PAN-
50Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
84.7
0.0
100.
076
.50.
0 (3
91)
2.2
0.0
1.5
1.3
0.1
4M
eDiP
ro M
alar
ia A
g H
RP2/
pLDH
Com
boIR
-005
1KFo
rmos
a Bi
omed
ical
Tech
nolo
gy C
orp.
69.4
2.9
99.0
0.0
0.0
(391
)0.
00.
01.
50.
90.
14
Nan
oSig
n M
alar
ia p
f/pa
n Ag
3.0
jRM
AP10
Biol
and
Ltd.
92.9
97.1
100.
010
0.0
0.8
0.0
0.0
0.0
0.4
0.0
4
Tabl
e S1
(co
ntin
ued)
10 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Pane
l Det
ectio
n Sc
orea
False
-pos
itive
rat
es (%
)To
tal f
alse
-pos
itive
ra
tesb
(%)
Inva
lid
rate
(%)
(n=1
192)
Ro
und
200
pa
rasit
es/μ
l20
00 o
r 50
00
para
sites
/μl
200
pa
rasit
es/μ
l20
00 o
r 50
00
para
sites
/μl
Clea
n-ne
gativ
e sa
mpl
es
Pf samplesc
Pv samplesd
Pf samplesc
Pv samplesd
Pf s
ampl
esPv
sam
ples
Pf s
ampl
esPv
sam
ples
Fals
e-po
sitiv
e
non
Pf
infe
ctio
ne
Fals
e-po
sitiv
e
Pf
infe
ctio
nf
Fals
e-po
sitiv
e
non
Pf
infe
ctio
ng
Fals
e-po
sitiv
e
Pf
infe
ctio
nh
False
-pos
itive
Pl
asm
odiu
m sp
p.
Infe
ctio
ni
Nan
oSig
n M
alar
ia P
f/Pv
Ag
RMAD
10Bi
olan
d, L
td6.
18.
689
.910
0.0
0.5
0.0
(139
)0.
00.
00.
00.
13
One
Step
Mal
aria
Ant
igen
Str
ip82
0-1
IND
Diag
nost
ic In
c.1.
30.
067
.160
.02.
23.
81.
90.
01.
8 (1
67)
0.0
1On
e St
ep M
alar
ia P
.f/Pa
n Te
stj
W56
-CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
37.4
85.7
95.0
100.
08.
4 (3
83)
0.0
(137
)0.
0 (1
94)
0.0
(68)
4.1
(195
)2.
43
OnSi
ght™
– P
araQ
uick
(Pan
, Pf)
Test
536-
25DB
Amge
nix
Inte
rnat
iona
l, In
c.59
.550
.010
0.0
100.
00.
01.
30.
00.
00.
00.
01
OnSi
te P
f/Pa
n Ag
Rap
id T
estj
R011
3CCT
K Bi
otec
h, In
c.74
.588
.298
.097
.10.
00.
00.
01.
50.
00.
04
OptiM
AL-I
T 71
0024
Diam
ed -
A D
ivis
ion
of B
io-R
ad50
.597
.196
.068
.61.
50.
00.
520
.3 (6
9)2.
0 (1
98)
0.5
3Pa
raH
IT -
Tot
al V
er. 1
.0 (D
evic
e)55
IC20
4-10
Span
Dia
gnos
tics
Ltd.
84.7
82.4
99.0
91.2
0.3
0.0
0.5
3.0
(67)
0.0
0.1
4Pa
raH
IT -
Tot
al V
er. 1
.0 (D
ipst
ick)
55IC
203-
10Sp
an D
iagn
ostic
s Lt
d.76
.561
.810
0.0
94.1
0.8
0.0
0.0
1.5
0.0
0.0
4Pa
raH
IT®
tota
l (di
pstic
k)55
IC20
1-10
Span
Dia
gnos
tics
Ltd
64.0
10.0
99.0
97.5
0.0
0.0
0.0
0.0
7.0
0.0
2Pa
rahi
t-To
tal D
evic
e Ra
pid
test
for P
. fal
cipa
rum
and
Pan
m
alar
ial s
peci
es.
2598
9Sp
an D
iagn
ostic
s Lt
d.35
.40.
093
.750
.00.
0 (3
15)
0.0
0.0
2.5
0.0
0.2
1
Para
scre
en®
- Ra
pid
test
for M
alar
ia P
an/P
fj50
3100
25Ze
phyr
Bio
med
ical
s99
.026
.510
0.0
23.5
0.0
(391
)30
.20.
050
.026
.70.
34
Quic
kstic
k M
alar
ia A
ntig
en T
est
--In
nova
tek
Med
ical
Inc.
1.3
0.0
67.1
60.0
2.2
3.8
1.9
0.0
1.8
(167
)0.
01
SD B
IOLI
NE
Mal
aria
Ag
P.f/
Panj
05FK
60St
anda
rd D
iagn
ostic
s In
c.92
.997
.199
.010
0.0
0.5
(394
)0.
00.
50.
03.
5 (1
99)
0.3
3SD
BIO
LIN
E M
alar
ia A
g Pf
/ Pan
05FK
66St
anda
rd D
iagn
ostic
s In
c.
90.8
94.1
100.
010
0.0
1.0
(385
)0.
0 (1
30)
0.0
(195
)0.
0 (6
7)1.
3 (2
26)
2.8
4SD
BIO
LIN
E M
alar
ia A
gj 05
FK40
Stan
dard
Dia
gnos
tics
Inc.
16.2
97.1
93.9
100.
00.
80.
00.
00.
00.
00.
03
Sure
step
™ E
asy
Mal
aria
Pf/
Pan
Rapi
d Te
st D
evic
e IM
A-T4
02AC
ON B
iote
ch (H
angz
hou)
Co.
Ltd
.83
.80.
010
0.0
100.
00.
00.
00.
00.
01.
00.
03
Pf a
nd P
vAd
vanc
ed Q
ualit
y™ O
ne S
tep
Mal
aria
P.f/
P.v
Tri-
Line
Tes
t IT
P110
03 T
C40
InTe
c Pr
oduc
ts, I
nc.
86.9
0.0
100.
05.
715
.7 (3
95)
5.7
8.1
(197
)4.
318
.50.
23
Adva
ntag
e M
alar
ia C
ard
IR21
1025
J. M
itra
& C
o. P
vt. L
td.
77.8
31.4
99.0
100.
00.
50.
70.
00.
00.
00.
03
BION
OTE
MAL
ARIA
P.f.
& P
.v. A
g Ra
pid
Test
Kit
RG19
-12
Bion
ote,
Inc.
92.9
97.1
98.0
100.
00.
30.
71.
5 (1
97)
0.0
4.0
0.0
3Ca
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOj
G01
61Ac
cess
Bio
, Inc
.90
.894
.110
0.0
100.
00.
30.
01.
01.
50.
00.
04
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) COM
BOj
G01
71Ac
cess
Bio
, Inc
.89
.891
.210
0.0
100.
00.
30.
70.
52.
90.
00.
04
Core
™ M
alar
ia P
v/Pf
MAL
-190
022
Core
Dia
gnos
tics
98.0
60.0
100.
097
.10.
30.
00.
00.
04.
00.
13
diag
nost
icks
- M
alar
ia (P
v/Pf
) Cas
sett
eKM
VFC6
002
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
91.0
45.0
99.0
100.
00.
3 (3
99)
0.6
0.0
0.0
2.0
0.1
2Fa
lciV
ax™
- R
apid
test
for M
alar
ia P
v/Pf
j50
3000
25Ze
phyr
Bio
med
ical
s98
.088
.210
0.0
100.
00.
82.
90.
02.
97.
30.
04
Firs
tSig
n™ –
Par
aVie
w-2
(Pv
+ Pf
) Car
d Te
st21
02CB
-25
Uni
med
Inte
rnat
iona
l, In
c.48
.10.
098
.785
.01.
03.
8N
A5.
00.
0 (1
67)
0.0
1H
iSen
s M
alar
ia A
g P.
f/P.
v Co
mbo
Car
dH
R312
3H
BI C
o., L
td.
89.8
79.4
100.
094
.10.
3 (3
91)
0.0
0.5
0.0
0.4
0.1
4H
iSen
s M
alar
ia A
g P.
f/VO
M C
ombo
Car
dH
R332
3H
BI C
o., L
td.
89.8
76.5
100.
091
.20.
00.
00.
50.
00.
00.
04
Hum
asis
Mal
aria
P.f/
P.v
Antig
en T
est
AMFV
-702
5H
umas
is, C
o., L
td.
92.9
100.
010
0.0
100.
00.
50.
70.
51.
51.
30.
04
Mal
aria
pf (
HRP
II) /
pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
1-13
-101
-3U
nite
d Bi
otec
h, In
c.
60.2
0.0
92.9
26.5
0.5
0.0
(135
)3.
1 (1
95)
1.5
0.0
(230
)0.
54
Mal
aria
pf (
HRP
II) /
pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
MFV
-124
VAZ
OG, I
nc.
79.8
0.0
100.
020
.00.
01.
40.
00.
00.
0 (1
99)
0.1
3M
alar
ia P
f/Pv
GM
002
Geno
mix
Mol
ecul
ar D
iagn
ostic
s Pvt
.Ltd.
40.8
0.0
94.9
5.9
0.8
0.7
0.5
0.0
0.9
0.0
4M
aler
isca
n® M
alar
ia P
f/Pv
M
AT-5
0Bh
at B
io-T
ech
Indi
a (P
) Ltd
52.0
0.0
97.0
60.0
1.8
(399
)2.
532
.52.
5 (7
9)1.
5 (1
99)
0.4
2M
edis
enso
r Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOM
161
Med
isen
sor,
Inc.
90.8
94.1
100.
010
0.0
0.3
0.0
1.0
1.5
0.0
0.0
4M
edis
enso
r Mal
aria
HRP
2/pL
DH (P
f/VO
M) C
OMBO
M17
1M
edis
enso
r, In
c.89
.891
.210
0.0
100.
00.
30.
70.
52.
90.
00.
04
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co.
, Ltd
.50
.00.
095
.991
.20.
02.
90.
01.
51.
30.
04
OnSi
ght™
- P
araQ
uick
-2 (P
v,Pf)
Mal
aria
Tes
t53
7-25
-DB
Amge
nix
Inte
rnat
iona
l, In
c.92
.037
.510
0.0
100.
00.
51.
90.
00.
03.
50.
12
OnSi
te P
f/Pv
Ag
Rapi
d Te
stj
R011
2CCT
K Bi
otec
h, In
c.79
.610
0.0
100.
010
0.0
1.5
0.0
2.0
0.0
1.3
0.0
4
Tabl
e S1
(co
ntin
ued)
sUM
Mar
Y r
oU
nd
s 1-
4
11Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Pane
l Det
ectio
n Sc
orea
False
-pos
itive
rat
es (%
)To
tal f
alse
-pos
itive
ra
tesb
(%)
Inva
lid
rate
(%)
(n=1
192)
Ro
und
200
pa
rasit
es/μ
l20
00 o
r 50
00
para
sites
/μl
200
pa
rasit
es/μ
l20
00 o
r 50
00
para
sites
/μl
Clea
n-ne
gativ
e sa
mpl
es
Pf samplesc
Pv samplesd
Pf samplesc
Pv samplesd
Pf s
ampl
esPv
sam
ples
Pf s
ampl
esPv
sam
ples
Fals
e-po
sitiv
e
non
Pf
infe
ctio
ne
Fals
e-po
sitiv
e
Pf
infe
ctio
nf
Fals
e-po
sitiv
e
non
Pf
infe
ctio
ng
Fals
e-po
sitiv
e
Pf
infe
ctio
nh
False
-pos
itive
Pl
asm
odiu
m sp
p.
Infe
ctio
ni
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOG
0161
Acce
ss B
io E
thio
pia
90.8
94.1
100.
010
0.0
0.3
0.0
1.0
1.5
0.0
0.0
4Pa
raCa
re M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) COM
BOG
0171
Acce
ss B
io E
thio
pia
89.8
91.2
100.
010
0.0
0.3
0.7
0.5
2.9
0.0
0.0
4
RAPI
D 1-
2-3®
HEM
A CA
SSET
TE M
ALAR
IA P
F/PV
TES
TM
AL-P
FV-
CAS/
25(1
00)
Hem
a Di
agno
stic
Sys
tem
s, LL
C92
.979
.410
0.0
100.
00.
00.
70.
01.
54.
30.
04
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
vk05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
96.9
97.1
100.
010
0.0
0.3
0.0
0.5
0.0
2.2
0.0
4SD
BIO
LIN
E M
alar
ia A
g Pf
/Pv
05FK
80St
anda
rd D
iagn
ostic
s, In
c.96
.095
.010
0.0
100.
00.
00.
0 (1
59)
0.0
(199
)0.
03.
50.
22
Trus
ty™
Mal
aria
Ant
igen
P.f.
/p.v.
test
A03-
12-3
22Ar
tron
Lab
orat
orie
s In
c.88
.838
.299
.010
0.0
13.3
27.4
(135
)16
.0 (1
94)
19.4
(67)
32.0
(231
)0.
54
Pf, P
v an
d Pa
nCo
re™
Mal
aria
Pan
/Pv/
Pf
MAL
-190
026
Core
Dia
gnos
tics
92.9
11.4
99.0
94.3
0.3
(391
)0.
0 (1
37)
0.0
(197
)1.
43.
5 (1
98)
1.0
3di
agno
stic
ks M
ALAR
IA (P
an/P
v/Pf
) Cas
sett
eM
PNVF
C100
7.5
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
93.9
11.4
99.0
94.3
0.0
(389
)0.
0 (1
39)
0.0
(196
)2.
9 (6
9)4.
0 (1
99)
1.1
3Fi
rstS
ign™
- P
araV
iew
-3 (P
an+P
v+Pf
) Mal
aria
Tes
t21
03 C
B-25
Uni
med
Inte
rnat
iona
l Inc
.89
.045
.010
0.0
100.
00.
0 (3
99)
2.5
0.0
0.0
24.5
0.1
2Pa
ram
ax-3
Rap
id T
est f
or M
alar
ia P
an/P
v/Pf
(dev
ice)
5032
0025
Zeph
yr B
iom
edic
als
93.0
45.0
100.
010
0.0
0.0
(396
)0.
0 (1
59)
0.0
(199
)0.
037
.0 (1
98)
0.7
2Pa
n on
lyAd
vant
age
Pan
Mal
aria
Car
dIR
0130
25J.
Mitr
a &
Co.
Pvt
. Ltd
.72
.210
0.0
100.
010
0.0
NA
NA
NA
NA
1.8
0.0
1AZ
OG h
CG M
alar
ia D
etec
tion
Test
Dev
ice
MPT
-124
AZOG
, IN
C.61
.20
9955
.9N
AN
AN
AN
A2.
20.
24
Care
Star
t™ M
alar
ia p
LDH
(PAN
)G
0111
Acce
ss B
io, I
nc.
92.4
100.
010
0.0
100.
0N
AN
AN
AN
A6.
60.
01
Clea
rvie
w®
Mal
aria
pLD
Hj
7088
4025
Orge
nics
Ltd
. (In
vern
ess
Med
ical
In
nova
tions
)81
.885
.799
.010
0.0
NA
NA
NA
NA
13.5
0.5
3
diag
nost
icks
MAL
ARIA
(Pan
) Cas
sett
e M
PNW
BC10
07.3
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
16.2
54.3
92.9
100.
0N
AN
AN
AN
A0.
00.
33
Firs
t Res
pons
e® M
alar
ia A
g pL
DHI1
2FRC
30Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
31.0
92.5
98.0
100.
0N
AN
AN
AN
A0.
00.
02
Firs
tSig
n™ -
Pan
Chec
k (P
an) M
alar
ia T
est
2104
CB-
25U
nim
ed In
tern
atio
nal I
nc.
25.0
82.5
87.0
100.
0N
AN
AN
AN
A2.
50.
22
OnSi
ght™
- P
anSc
reen
(Pan
) Mal
aria
Tes
t53
9-25
-DB
Amge
nix
Inte
rnat
iona
l, In
c.22
.077
.596
.010
0.0
NA
NA
NA
NA
2.5
0.2
2Pa
raba
nk™
Dev
ice
- Ra
pid
test
for M
alar
ia P
anj
5030
1025
Zeph
yr B
iom
edic
al S
yste
ms
17.2
62.9
90.9
100.
0N
AN
AN
AN
A0.
50.
23
Pv o
nly
SD B
IOLI
NE
Mal
aria
Ag
Pv05
FK70
Stan
dard
Dia
gnos
tics,
Inc.
NA
92.5
NA
100.
00.
3N
A1.
0N
A1.
00.
02
NA,
not
app
licab
le
Pf, P
lasm
odiu
m fa
lcip
arum
P
v, Pl
asm
odiu
m v
ivax
p
an, P
lasm
odiu
m sp
ecie
sa
A sa
mpl
e is
con
side
red
dete
cted
onl
y if
all R
DTs
from
bot
h lo
ts re
ad b
y th
e fir
st
tech
nici
an, a
t min
imum
spe
cifie
d re
adin
g tim
e, a
re p
ositi
veb
The
tota
l num
ber o
f tim
es a
pos
itive
resu
lt fo
r mal
aria
was
gen
erat
ed w
hen
it sh
ould
no
t hav
e be
en
c Ro
und
1, n
=79;
Rou
nd 2
, n=1
00; R
ound
3, n
=99;
Rou
nd 4
, n=9
8d
Roun
d 1,
n=2
0; R
ound
2, n
=40;
Rou
nd 3
, n=3
5; R
ound
4, n
=34
e Fo
r com
bina
tion
test
s, Pa
n or
Pv
line,
only,
pos
itive
indi
cate
s a fa
lse-p
ositi
ve n
on P.
falci
paru
m
infe
ctio
n (R
ound
1 n
=316
; Rou
nd 2
, n=4
00; R
ound
3, n
=396
; Rou
nd 4
, n=3
92)
f Pf
line
pos
itive
indi
cate
s a
fals
e-po
sitiv
e P.
falc
ipar
um in
fect
ion
(Rou
nd 1
, n=8
0; R
ound
2,
n=1
60; R
ound
3, n
=140
; Rou
nd 4
, n=1
36)
g
For c
ombi
natio
n te
sts,
Pan
or P
v lin
e, o
nly,
posi
tive
indi
cate
s a
fals
e-po
sitiv
e no
n-P.
falc
ipar
um in
fect
ion
(Rou
nd 1
, n=1
58, R
ound
2, n
=200
; Ro
und
3, n
=198
; Rou
nd 4
, n=1
96)
h Pf
line
pos
itive
indi
cate
s a
fals
e-po
sitiv
e P.
falc
ipar
um in
fect
ion
(Rou
nd 1
, n=
40; R
ound
2, n
=80,
Rou
nd 3
, n=7
0; R
ound
4, n
=68)
i Ro
und
1, n
=168
; Rou
nd 2
, n=2
00; R
ound
3, n
=200
; Rou
nd 4
, n=2
32
j Pr
oduc
t res
ubm
issi
on, r
esul
ts fr
om m
ost r
ecen
t rou
nd o
f tes
ting
repl
ace
prev
ious
resu
lts. R
efer
to T
able
S3.
k PD
S pr
esen
ted
in th
e ta
ble
is b
ased
on
a po
sitiv
e pf
test
line
(eith
er
pf-H
RP2
or p
f-pL
DH).
For t
est l
ine
spec
ific
resu
lts re
fer t
o th
e ta
bles
and
an
nexe
s in
the
full
repo
rts.
Dete
ctio
n ra
te (%
)≥9
585
-94
50-8
4<
50
Fals
e-po
sitiv
e ra
te (%
)<2
2-5
6 -1
0>1
0
Inva
lid ra
te (%
)<1
% o
f tes
ts
cond
ucte
d1-
2% o
f tes
ts
cond
ucte
d2-
5% o
f tes
ts
cond
ucte
d>5
% o
f tes
ts
cond
ucte
d
Tabl
e S1
(co
ntin
ued)
12 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Tabl
e S2
: Mal
aria
RDT
Rou
nds
1—4
heat
sta
bilit
y re
sult
s on
a c
ultu
red
P. f
alci
paru
m s
ampl
e at
low
(20
0) a
nd h
igh
(200
0) p
aras
ite
dens
ity
(par
asit
es/µ
l). P
ositi
vity
rat
e at
bas
elin
e, a
nd a
fter
60
days
in
cuba
tion
at 3
5°C
and
45°C
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pan
line
)Pe
rcen
t po
sitiv
e te
st r
esul
ts
for
P. f
alci
paru
m (P
an li
ne)
Roun
d20
0 pa
rasit
es/μ
l20
00 p
aras
ites/
μl20
0 pa
rasit
es/μ
l20
00 p
aras
ites/
μl
Base
line
35°C
45°C
Base
line
35°C
45°C
Base
line
35°C
45°C
Base
line
35°C
45°C
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
ned
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
ned
Pf o
nly
ABON
™ M
alar
ia P
.f. R
apid
Tes
t Dev
ice
(Who
le B
lood
)IM
A-40
2AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td15
.015
.017
.010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4Ad
vanc
ed Q
ualit
y™ O
ne S
tep
Mal
aria
P.f
Test
aIT
P110
02TC
40In
Tec
Prod
ucts
, Inc
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
Adva
nced
Qua
lity™
Mal
aria
(p.
f) PO
CTIT
P110
02TC
1In
Tec
Prod
ucts
, Inc
.80
.095
.090
.010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
1Ad
vant
age
P.f.
Mal
aria
Car
dIR
0160
25J.
Mitr
a &
Co.
Pvt
. Ltd
.95
.010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
1BI
OCRE
DIT
Mal
aria
pf(H
RP II
)H
R010
0Ra
piG
en In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
BION
OTE
MAL
ARIA
P.f.
Ag
Rapi
d Te
st K
it RG
19-1
1Bi
onot
e,In
c.10
0.0
100.
086
.710
0.0
90.0
80.0
NA
NA
NA
NA
NA
NA
3Ca
reSt
art™
Mal
aria
HRP
2 (P
f)G
0141
Acce
ss B
io, I
nc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
1Ca
reSt
art™
Mal
aria
HRP
2/pL
DH P
f tes
tG
0181
Acce
ss B
io, I
nc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
2Cl
earv
iew
® M
alar
ia P
.f.a
VB01
Visi
on B
iote
ch (P
ty) L
td10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
Core
™ M
alar
ia P
f M
AL-1
9002
0Co
re D
iagn
ostic
s10
0.0
100.
096
.710
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3di
agno
stic
ks-
Mal
aria
(Pf)
Cass
ette
KM
FC60
01SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
s95
.070
.055
.095
.095
.095
.0N
AN
AN
AN
AN
AN
A2
diag
nost
icks
- M
alar
ia (P
f) Di
pstic
k K
MFD
6007
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
2Fi
rst R
espo
nse®
Mal
aria
Ag
HRP
2I1
3FRC
30Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
1Fi
rstS
ign™
– M
alar
ia P
f Car
d Te
st--
Uni
med
Inte
rnat
iona
l, In
c.20
.015
.00.
010
0.0
90.0
95.0
NA
NA
NA
NA
NA
NA
1Fi
rstS
ign™
Mal
aria
Pf
2100
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4H
exag
on M
alar
ia58
051
Hum
an G
mbH
50.0
35.0
60.0
95.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
1H
iSen
s M
alar
ia A
g Pf
HRP
2 Ca
rd
HR3
023
HBI
Co.
, Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A2
ICT
Diag
nost
ics
Mal
aria
P.f.
aM
L01
ICT
Diag
nost
ics
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3IM
MU
NOQ
UIC
K CO
NTA
CT fa
lcip
arum
05
19K2
5Bi
osyn
ex10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
Imm
unoq
uick
Mal
aria
Fal
cipa
rum
0502
_K25
Bios
ynex
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
1IN
D ON
E ST
EP M
ALAR
IA A
NTI
GEN
P.f
535-
11IN
D Di
agno
stic
s In
c.10
0.0
100.
086
.710
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4M
alar
ia P
lasm
odiu
m fa
lcip
arum
Rap
id te
st D
evic
e (W
hole
blo
od)
IMA-
402
ACON
Lab
orat
orie
s, In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A1
Mal
eris
can
® M
alar
ia P
.f An
tigen
Tes
tM
AT-P
F-50
Bhat
Bio
-Tec
h In
dia
(Pte
.) Lt
d.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Nan
oSig
n M
alar
ia P
f Ag
RMAF
10Bi
olan
d, L
td96
.710
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3On
e St
ep M
alar
ia P
.F T
est (
Cass
ette
)a 52
2352
Blue
Cro
ss B
io-M
edic
al (B
eijin
g) C
o., L
td.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4On
Sigh
t™ -
Mal
aria
Pf T
est
511-
25-D
BAm
geni
x In
tern
atio
nal,
Inc.
100.
095
.090
.010
0.0
100.
065
.0N
AN
AN
AN
AN
AN
A2
OnSi
te P
f Ag
Rapi
d Te
sta
R0
114C
CTK
Biot
ech,
Inc.
96.7
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipa
rum
Mal
aria
Dev
ice
(Ver
.3)j
3030
1025
Orch
id B
iom
edic
al S
yste
ms
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4Pa
rach
eck®
Pf-
Rapi
d Te
st fo
r P. f
alci
paru
m M
alar
ia D
ipst
ick
(Ver
.3)j
3030
2025
Orch
id B
iom
edic
al S
yste
ms
100.
096
.710
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Para
HIT
® -
f (D
evic
e)a
55
IC10
2-50
Span
Dia
gnos
tics
Ltd.
100.
096
.710
0.0
100.
010
0.0
90.0
NA
NA
NA
NA
NA
NA
3Pa
raH
IT®
-f (D
ipst
ick)
a 55
IC10
1-50
Span
Dia
gnos
tics
Ltd.
100.
010
0.0
56.7
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
SD B
IOLI
NE
Mal
aria
Ag
P.f.
(HRP
2/pL
DH)b
05FK
90St
anda
rd D
iagn
ostic
s In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
SD B
IOLI
NE
Mal
aria
Ag
Pf05
FK50
Stan
dard
Dia
gnos
tics,
Inc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
1Tr
usty
™ M
alar
ia A
ntig
en P
.f. te
stA0
3-11
-322
Artr
on L
abor
ator
ies
Inc.
100.
010
0.0
56.7
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Won
dfo
One
Step
Mal
aria
P.f
Test
aW
37-
CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
100.
096
.710
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Pf a
nd P
anAB
ON M
alar
ia P
an/P
.f. R
apid
Tes
t Dev
ice
IM
A-B4
02AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td.
100.
080
.090
.010
0.0
100.
010
0.0
0.0
0.0
0.0
0.0
0.0
0.0
3AB
ON™
Plu
s M
alar
ia P
.f/Pa
n Ra
pid
Test
Dev
ice
(Who
le B
lood
)IM
A-T4
02AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
00.
00.
00.
00.
0
sUM
Mar
Y r
oU
nd
s 1-
4
13Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pan
line
)Pe
rcen
t po
sitiv
e te
st r
esul
ts
for
P. f
alci
paru
m (P
an li
ne)
Roun
d20
0 pa
rasit
es/μ
l20
00 p
aras
ites/
μl20
0 pa
rasit
es/μ
l20
00 p
aras
ites/
μl
Base
line
35°C
45°C
Base
line
35°C
45°C
Base
line
35°C
45°C
Base
line
35°C
45°C
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
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itive
Num
ber
of t
ests
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itive
Num
ber
of t
ests
pos
itive
Lots
1 a
nd 2
com
bine
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and
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ned
Lots
1 a
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com
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2 c
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ned
Adva
ntag
e M
al C
ard
IR22
1025
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itra
& C
o. P
vt. L
td.
100.
010
0.0
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95.0
100.
095
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0.0
100.
010
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OG M
alar
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ntig
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C.96
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0.0
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0.0
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30.
00.
020
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00.
04
Bina
x N
ow M
alar
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Inve
rnes
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nova
tions
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100.
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95.0
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0.0
0.0
0.0
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010
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0.0
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0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
03
Care
Star
t™ M
alar
ia H
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PAN
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BOG
0131
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ss B
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100.
095
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0.0
100.
010
0.0
100.
010
0.0
95.0
100.
010
0.0
100.
010
0.0
1Ca
reSt
art™
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aria
pLD
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Lin
e Te
st
GO1
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cess
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.10
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
03
Care
Star
t™ M
alar
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cree
n G
O231
Acce
ss B
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100.
010
0.0
93.3
100.
010
0.0
100.
010
0.0
100.
093
.310
0.0
100.
010
0.0
3Cl
earv
iew
® M
alar
ia C
ombo
a VB
11Vi
sion
Bio
tech
(Pty
) Ltd
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
90.0
20.0
0.0
3Cl
earv
iew
® M
alar
ia D
ual T
est D
evic
ea VB
20Vi
sion
Bio
tech
(Pty
) Ltd
100.
010
0.0
96.7
100.
010
0.0
100.
00.
00.
00.
050
.090
.020
.03
Core
Mal
aria
Pan
Pf
MAL
-190
024
Core
Dia
gnos
tics
Ltd.
100.
010
0.0
100.
010
0.0
100.
010
0.0
26.7
80.0
83.3
100.
010
0.0
100.
04
diag
nost
icks
MAL
ARIA
(Pan
/Pf)
Cass
ette
M
PNFW
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Diag
nost
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& B
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yste
ms
100.
010
0.0
96.7
100.
010
0.0
100.
00.
00.
00.
010
0.0
90.0
90.0
3
EzDx
™ M
alar
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an/P
f Rap
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est D
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tion
kit
RK M
AL 0
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rat
Seru
ms
& V
acci
nes
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)10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
00.
010
0.0
100.
070
.04
Firs
t Res
pons
e® M
alar
ia p
LDH
/HRP
2 Co
mbo
Tes
ta I1
6FRC
30Pr
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r Med
ical
Cor
pora
tion
Ltd.
100.
010
0.0
100.
010
0.0
100.
010
0.0
85.0
55.0
55.0
100.
010
0.0
100.
02
Firs
tSig
n™ P
araV
iew
(Pan
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nim
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tern
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nc.
96.7
100.
010
0.0
100.
010
0.0
100.
00.
00.
013
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0.0
100.
010
0.0
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exag
on M
alar
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4H
uman
Gm
bH65
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.050
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0.0
85.0
95.0
0.0
0.0
0.0
0.0
0.0
0.0
1H
iSen
s M
alar
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g P.
f/P.
v Ca
rd
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823
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, Ltd
.35
.00.
05.
010
0.0
100.
010
0.0
0.0
0.0
0.0
35.0
0.0
0.0
2H
iSen
s M
alar
ia A
g Pf
/Pv
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ard
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923
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Co.
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0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
095
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0.0
100.
010
0.0
2H
umas
is M
alar
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.f/Pa
n An
tigen
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tAM
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Co.
, Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
076
.710
0.0
100.
010
0.0
100.
010
0.0
4IC
T Di
agno
stic
s M
alar
ia D
ual
ML0
3IC
T Dia
gnos
tics
100.
010
0.0
93.3
100.
010
0.0
100.
00.
00.
00.
010
0.0
80.0
0.0
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T M
ALAR
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OMBO
aM
L02
ICT
INTE
RNAT
ION
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.310
0.0
100.
010
0.0
3.3
20.0
13.3
100.
050
.070
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IMM
UN
OQU
ICK
CON
TACT
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K25
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ynex
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
50.0
50.0
100.
03
Imm
unoq
uick
Mal
aria
+4
0506
_K25
Bios
ynex
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
100.
080
.080
.01
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN P
.f/Pa
n TE
ST53
5-10
IND
Diag
nost
ics
Inc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
20.0
3.3
33.3
100.
010
0.0
100.
04
Mal
aria
P.F
/Viv
ax17
211O
P-25
Diag
nost
ics
Auto
mat
ion/
Cort
ez
Diag
nost
ics,
Inc.
65.0
15.0
20.0
65.0
45.0
5.0
0.0
0.0
0.0
0.0
0.0
0.0
1
Mal
aria
Pan
Tes
t M
AL-W
23N
-001
Dim
a •
Gese
llsch
aft f
ür D
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a m
bH60
.033
.323
.310
0.0
100.
090
.013
.353
.340
.010
.060
.040
.03
Mal
aria
pf (
HRP
II) /
(PAN
-pLD
H) A
ntig
en D
etec
tion
Test
Dev
icea
MFV
-124
RAZ
OG, I
nc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
0.0
0.0
0.0
3M
alar
ia p
f (H
RP II
)/PAN
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
1-13
-101
-1U
nite
d Bi
otec
h, In
c.
100.
096
.796
.710
0.0
100.
010
0.0
16.6
0.0
0.0
90.0
40.0
50.0
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alar
ia p
f (pL
DH) /
PAN
-pLD
H T
est D
evic
e
MFV
-124
AZOG
, Inc
.3.
30.
00.
040
.010
.00.
00.
00.
00.
00.
00.
00.
03
Mal
aria
Pf/
PAN
GM
004
Geno
mix
Mol
ecul
ar D
iagn
ostic
s Pvt
.Ltd.
56.7
23.3
26.7
100.
010
0.0
100.
00.
00.
00.
060
.090
.050
.04
Mal
asca
n™ D
evic
e -
Rapi
d te
st fo
r Mal
aria
Pf/
Pana
5040
2025
Zeph
yr B
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al S
yste
ms
96.7
100.
096
.710
0.0
100.
010
0.0
0.0
0.0
6.7
100.
010
0.0
100.
03
Mal
eris
can®
Mal
aria
P.f/
PAN
(Pv,
Pm, P
o) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PA
N-5
0Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
0.0
0.0
0.0
4M
eDiP
ro M
alar
ia A
g H
RP2/
pLDH
Com
boIR
-005
1KFo
rmos
a Bi
omed
ical
Tech
nolo
gy C
orp.
100.
096
.796
.710
0.0
100.
010
0.0
0.0
0.0
0.0
0.0
0.0
0.0
4N
anoS
ign
Mal
aria
pf/
pan
Ag 3
.0a
RMAP
10Bi
olan
d Lt
d.10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
00.
010
0.0
100.
010
0.0
4N
anoS
ign
Mal
aria
Pf/
Pv A
g RM
AD10
Biol
and,
Ltd
0.0
0.0
0.0
20.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
3On
e St
ep M
alar
ia A
ntig
en S
trip
820-
1IN
D Di
agno
stic
Inc.
15.0
0.0
0.0
65.0
50.0
0.0
15.0
0.0
0.0
65.0
50.0
5.0
1On
e St
ep M
alar
ia P
.f/Pa
n Te
sta
W56
-CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
46.7
13.3
26.7
100.
010
0.0
100.
00.
036
.773
.370
.080
.010
0.0
3On
Sigh
t™ –
Par
aQui
ck (P
an, P
f) Te
st53
6-25
DBAm
geni
x In
tern
atio
nal,
Inc.
100.
090
.060
.010
0.0
100.
010
0.0
0.0
0.0
0.0
100.
010
0.0
95.0
1On
Site
Pf/
Pan
Ag R
apid
Tes
taR0
113C
CTK
Biot
ech,
Inc.
100.
010
0.0
93.3
100.
010
0.0
100.
00.
03.
30.
070
.020
.010
.04
Tabl
e S2
(co
ntin
ued)
14 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pan
line
)Pe
rcen
t po
sitiv
e te
st r
esul
ts
for
P. f
alci
paru
m (P
an li
ne)
Roun
d20
0 pa
rasit
es/μ
l20
00 p
aras
ites/
μl20
0 pa
rasit
es/μ
l20
00 p
aras
ites/
μl
Base
line
35°C
45°C
Base
line
35°C
45°C
Base
line
35°C
45°C
Base
line
35°C
45°C
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
ned
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
ned
OptiM
AL-I
T 71
0024
Diam
ed -
A D
ivis
ion
of B
io-R
ad0.
00.
00.
010
0.0
90.0
0.0
0.0
0.0
0.0
100.
090
.00.
03
Para
HIT
- T
otal
Ver
. 1.0
(Dev
ice)
55IC
204-
10Sp
an D
iagn
ostic
s Lt
d.10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
00.
010
0.0
100.
010
0.0
4Pa
raH
IT -
Tot
al V
er. 1
.0 (D
ipst
ick)
55IC
203-
10Sp
an D
iagn
ostic
s Lt
d.10
0.0
93.3
46.7
100.
010
0.0
60.0
50.0
0.0
0.0
100.
090
.00.
04
Para
HIT
® to
tal (
dips
tick)
55IC
201-
10Sp
an D
iagn
ostic
s Lt
d55
.085
.055
.010
0.0
100.
095
.010
.00.
00.
050
.045
.070
.02
Para
hit-
Tota
l Dev
ice
Rapi
d te
st fo
r P. f
alci
paru
m a
nd P
an
mal
aria
l spe
cies
2598
9Sp
an D
iagn
ostic
s Lt
d.65
.075
.025
.095
.010
0.0
100.
05.
00.
00.
00.
00.
00.
01
Para
scre
en®
- Ra
pid
test
for M
alar
ia P
an/P
fa50
3100
25Ze
phyr
Bio
med
ical
s10
0.0
100.
010
0.0
100.
010
0.0
100.
086
.613
.383
.310
0.0
100.
010
0.0
4Qu
icks
tick
Mal
aria
Ant
igen
Tes
t--
Inno
vate
k M
edic
al In
c.15
.00.
00.
065
.050
.00.
015
.00.
00.
065
.050
.05.
01
SD B
IOLI
NE
Mal
aria
Ag
P.f/
Pana
05FK
60St
anda
rd D
iagn
ostic
s In
c.10
0.0
96.7
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
100.
070
.090
.03
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
an05
FK66
Stan
dard
Dia
gnos
tics
Inc.
96
.796
.710
0.0
90.0
100.
010
0.0
16.6
10.0
0.0
90.0
100.
010
0.0
4SD
BIO
LIN
E M
alar
ia A
ga 05
FK40
Stan
dard
Dia
gnos
tics
Inc.
0.0
0.0
0.0
100.
080
.090
.00.
00.
00.
080
.020
.090
.03
Sure
step
™ E
asy
Mal
aria
Pf/
Pan
Rapi
d Te
st D
evic
e IM
A-T4
02AC
ON B
iote
ch (H
angz
hou)
Co.
Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
00.
00.
00.
00.
03
Pf a
nd P
vAd
vanc
ed Q
ualit
y™ O
ne S
tep
Mal
aria
P.f/
P.v
Tri-
Line
Tes
t IT
P110
03 T
C40
InTe
c Pr
oduc
ts, I
nc.
96.7
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
Adva
ntag
e M
alar
ia C
ard
IR21
1025
J. M
itra
& C
o. P
vt. L
td.
100.
096
.796
.710
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3BI
ONOT
E M
ALAR
IA P
.f.&
P.v.
Ag
Rapi
d Te
st K
it RG
19-1
2Bi
onot
e,In
c.10
0.0
96.7
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3Ca
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOa
G01
61Ac
cess
Bio
, Inc
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) COM
BOa
G01
71Ac
cess
Bio
, Inc
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Core
™ M
alar
ia P
v/Pf
MAL
-190
022
Core
Dia
gnos
tics
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3di
agno
stic
ks-
Mal
aria
(Pv/
Pf) C
asse
tte
KMVF
C600
2SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
s10
0.0
95.0
95.0
100.
010
0.0
95.0
NA
NA
NA
NA
NA
NA
2Fa
lciV
ax™
- R
apid
test
for M
alar
ia P
v/Pf
a50
3000
25Ze
phyr
Bio
med
ical
s10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Firs
tSig
n™ –
Par
aVie
w-2
(Pv
+ Pf
) Car
d Te
st21
02CB
-25
Uni
med
Inte
rnat
iona
l, In
c.95
.070
.00.
010
0.0
95.0
75.0
NA
NA
NA
NA
NA
NA
1H
iSen
s M
alar
ia A
g P.
f/P.
v Co
mbo
Car
dH
R312
3H
BI C
o., L
td.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4H
iSen
s M
alar
ia A
g P.
f/VO
M C
ombo
Car
dH
R332
3H
BI C
o., L
td.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4H
umas
is M
alar
ia P
.f/P.
v An
tigen
Tes
tAM
FV-7
025
Hum
asis,
Co.
, Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Mal
aria
pf (
HRP
II) /
pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
1-13
-101
-3U
nite
d Bi
otec
h, In
c.
100.
010
0.0
100.
090
.010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Mal
aria
pf (
HRP
II) /
pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
MFV
-124
VAZ
OG, I
nc.
100.
010
0.0
96.7
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
Mal
aria
Pf/
PvG
M00
2Ge
nom
ix M
olec
ular
Dia
gnos
tics P
vt.Lt
d.40
.033
.340
.010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4M
aler
isca
n® M
alar
ia P
f/Pv
M
AT-5
0Bh
at B
io-T
ech
Indi
a (P
) Ltd
100.
060
.030
.010
0.0
90.0
95.0
NA
NA
NA
NA
NA
NA
2M
edis
enso
r Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOM
161
Med
isen
sor,
Inc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4M
edis
enso
r Mal
aria
HRP
2/pL
DH (P
f/VO
M) C
OMBO
M17
1M
edis
enso
r, In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co.
, Ltd
.40
.06.
70.
010
0.0
100.
090
.0N
AN
AN
AN
AN
AN
A4
OnSi
ght™
- P
araQ
uick
-2 (P
v,Pf)
Mal
aria
Tes
t53
7-25
-DB
Amge
nix
Inte
rnat
iona
l, In
c.10
0.0
100.
010
0.0
100.
010
0.0
85.0
NA
NA
NA
NA
NA
NA
2On
Site
Pf/
Pv A
g Ra
pid
Test
aR0
112C
CTK
Biot
ech,
Inc.
100.
010
0.0
90.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOG
0161
Acce
ss B
io E
thio
pia
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4Pa
raCa
re M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) COM
BOG
0171
Acce
ss B
io E
thio
pia
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4
RAPI
D 1-
2-3®
HEM
A CA
SSET
TE M
ALAR
IA P
F/PV
TES
TM
AL-P
FV-
CAS/
25(1
00)
Hem
a Di
agno
stic
Sys
tem
s, LL
C10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
vb05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
100.
010
0.0
96.7
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
v05
FK80
Stan
dard
Dia
gnos
tics,
Inc.
100.
010
0.0
100.
010
0.0
100.
095
.0N
AN
AN
AN
AN
AN
A2
Trus
ty™
Mal
aria
Ant
igen
P.f.
/p.v.
test
A03-
12-3
22Ar
tron
Lab
orat
orie
s In
c.10
0.0
100.
036
.710
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4
Tabl
e S2
(co
ntin
ued)
sUM
Mar
Y r
oU
nd
s 1-
4
15Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pan
line
)Pe
rcen
t po
sitiv
e te
st r
esul
ts
for
P. f
alci
paru
m (P
an li
ne)
Roun
d20
0 pa
rasit
es/μ
l20
00 p
aras
ites/
μl20
0 pa
rasit
es/μ
l20
00 p
aras
ites/
μl
Base
line
35°C
45°C
Base
line
35°C
45°C
Base
line
35°C
45°C
Base
line
35°C
45°C
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
ned
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
ned
Pf, P
v an
d Pa
nCo
re™
Mal
aria
Pan
/Pv/
Pf
MAL
-190
026
Core
Dia
gnos
tics
100.
010
0.0
100.
010
0.0
90.0
100.
00.
00.
00.
080
.050
.070
.03
diag
nost
icks
MAL
ARIA
(Pan
/Pv/
Pf) C
asse
tte
MPN
VFC1
007.
5SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
s96
.710
0.0
93.3
100.
010
0.0
100.
00.
00.
00.
070
.00.
050
.03
Firs
tSig
n™ -
Par
aVie
w-3
(Pan
+Pv+
Pf) M
alar
ia T
est
2103
CB-
25U
nim
ed In
tern
atio
nal I
nc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
60.0
50.0
15.0
100.
090
.010
0.0
2Pa
ram
ax-3
Rap
id T
est f
or M
alar
ia P
an/P
v/Pf
(dev
ice)
5032
0025
Zeph
yr B
iom
edic
als
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
025
.030
.010
0.0
95.0
100.
02
Pan
Onl
yAd
vant
age
Pan
Mal
aria
Car
dIR
0130
25J.
Mitr
a &
Co.
Pvt
. Ltd
.N
AN
AN
AN
AN
AN
A50
.065
.070
.010
0.0
100.
010
0.0
1AZ
OG h
CG M
alar
ia D
etec
tion
Test
Dev
ice
MPT
-124
AZOG
, IN
C.N
AN
AN
AN
AN
AN
A10
0.0
100.
010
0.0
100.
010
0.0
100.
04
Care
Star
t™ M
alar
ia p
LDH
(PAN
)G
0111
Acce
ss B
io, I
nc.
NA
NA
NA
NA
NA
NA
100.
010
0.0
90.0
100.
010
0.0
100.
01
Clea
rvie
w®
Mal
aria
pLD
Ha
7088
4025
Orge
nics
Ltd
. (In
vern
ess
Med
ical
In
nova
tions
)N
AN
AN
AN
AN
AN
A96
.793
.310
0.0
100.
010
0.0
100.
03
diag
nost
icks
MAL
ARIA
(Pan
) Cas
sett
e M
PNW
BC10
07.3
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
NA
NA
NA
NA
NA
NA
0.0
0.0
0.0
80.0
100.
080
.03
Firs
t Res
pons
e® M
alar
ia A
g pL
DHI1
2FRC
30Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
NA
NA
NA
NA
NA
NA
50.0
80.0
55.0
100.
010
0.0
100.
02
Firs
tSig
n™ -
Pan
Chec
k (P
an) M
alar
ia T
est
2104
CB-
25U
nim
ed In
tern
atio
nal I
nc.
NA
NA
NA
NA
NA
NA
25.0
5.0
10.0
100.
010
0.0
100.
02
OnSi
ght™
- P
anSc
reen
(Pan
) Mal
aria
Tes
t53
9-25
-DB
Amge
nix
Inte
rnat
iona
l, In
c.N
AN
AN
AN
AN
AN
A5.
035
.015
.010
0.0
100.
010
0.0
2Pa
raba
nk™
Dev
ice
- Ra
pid
test
for M
alar
ia P
ana
5030
1025
Zeph
yr B
iom
edic
al S
yste
ms
NA
NA
NA
NA
NA
NA
0.0
0.0
0.0
90.0
100.
010
0.0
3Pv
onl
ySD
BIO
LIN
E M
alar
ia A
g Pv
05FK
70St
anda
rd D
iagn
ostic
s, In
c.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A2
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
a Pr
oduc
t res
ubm
issi
on,
resu
lts fr
om m
ost r
ecen
t rou
nd o
f tes
ting
repl
ace
prev
ious
resu
lts. R
efer
to T
able
S3.
b
Resu
lts p
rese
nted
in th
e ta
ble
are
base
d on
sta
bilit
y of
a p
f tes
t lin
e (e
ither
pf-
HRP
2 or
pf-
pLDH
). Re
sults
bas
ed o
n st
abili
ty o
f ind
ivid
ual t
est l
ines
is p
rese
nted
in th
e fo
llow
ing
tabl
e:
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Perc
ent
posit
ive
test
res
ults
for
P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
for
P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
for
P.
fal
cipa
rum
(Pan
line
)Pe
rcen
t po
sitiv
e te
st r
esul
ts f
or
P. f
alci
paru
m (P
an li
ne)
Roun
d20
0 pa
rasit
es/μ
l20
00 p
aras
ites/
μl20
0 pa
rasit
es/μ
l20
00 p
aras
ites/
μl
Base
line
35°C
45°C
Base
line
35°C
45°C
Base
line
35°C
45°C
Base
line
35°C
45°C
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
ned
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
ned
SD B
IOLI
NE
Mal
aria
Ag
P.f.
(HRP
2/pL
DH) -
(PF(
HRP
2) li
ne)
05FK
90St
anda
rd D
iagn
ostic
s In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
SD B
IOLI
NE
Mal
aria
Ag
P.f.
(HRP
2/pL
DH)-
(PF(
pLDH
) lin
e)
05FK
90St
anda
rd D
iagn
ostic
s In
c.0.
00.
00.
033
.333
.333
.3N
AN
AN
AN
AN
AN
A3
AZOG
Mal
aria
pf (
HRP
II)/p
f (LD
H)/
(PAN
-LDH
) Ant
igen
De
tect
ion
Devi
ce -
(PF(
HRP
2) li
ne)
MFV
-124
FAZ
OG, I
NC.
96.7
96.7
100.
010
0.0
100.
010
0.0
3.3
0.0
0.0
20.0
0.0
0.0
4
AZOG
Mal
aria
pf (
HRP
II)/p
f (LD
H)/
(PAN
-LDH
) Ant
igen
De
tect
ion
Devi
ce -
(PF(
pLDH
) lin
e)M
FV-1
24F
AZOG
, IN
C.13
.33.
36.
750
.010
.050
.03.
30.
00.
020
.00.
00.
04
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
v -
(PF(
HRP
2) li
ne)
05FK
100
Stan
dard
Dia
gnos
tics
Inc.
10
0.0
100.
096
.710
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
v -
(PF(
pLDH
) lin
e)05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
26.7
3.3
3.3
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Tabl
e S2
(co
ntin
ued)
16 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Tabl
e S3
: Pro
duct
Res
ubm
issi
ons:
WH
O M
alar
ia R
DT P
rodu
ct T
estin
g -
Roun
ds 1
—4
Man
ufac
ture
rIn
itial
Tes
ting
Subs
eque
nt T
estin
g
Roun
dPr
oduc
t N
ame
Cata
logu
e N
o.
Roun
dPr
oduc
t N
ame
Cata
logu
e N
o.
Acce
ss B
Io, I
nc.
2Ca
reSt
art™
Mal
aria
HRP
2/PL
DH (P
f/Pv
) COM
BOG
0161
4Ca
reSt
art™
Mal
aria
HRP
2/PL
DH (P
f/Pv
) COM
BOG
0161
2Ca
reSt
art™
Mal
aria
HRP
2/PL
DH (P
f/VO
M) C
OMBO
G01
714
Care
Star
t™ M
alar
ia H
RP2/
PLDH
(Pf/
VOM
) COM
BOG
0171
AZOG
1M
alar
ia P
f (H
RPII)
/pv-
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
eaM
FV-1
24R
3M
alar
ia p
f (H
RP II
) / (P
AN-L
DH) A
ntig
en D
etec
tion
Test
Dev
ice
MFV
-124
RBi
olan
d3
Nan
oSig
n M
alar
ia P
f/Pa
n Ag
RM
AP10
4N
anoS
ign
Mal
aria
Pf/
Pan
Ag
RMAP
10Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co.
, Ltd
.2
One
Step
Mal
aria
Pf T
est (
cass
ette
)52
2352
3, 4
One
Step
Mal
aria
P.F
Tes
t (ca
sset
te)
5223
52
CTK
Biot
ech,
Inc.
2On
site
Pf A
g Ra
pid
Test
R0
114C
3On
Site
Pf A
g Ra
pid
Test
R011
4C2
Onsi
te P
f/Pa
n Ag
Rap
id T
est
R011
3C3,
4On
Site
Pf/
Pan
Mal
aria
Ag
Rapi
d Te
stR0
113C
2On
site
Pf/
Pv A
g Ra
pid
Test
R0
112C
3, 4
OnSi
te M
alar
ia P
f/Pv
Ag
Rapi
d Te
stR0
112C
DiaM
ed -
A D
ivis
ion
of B
io-R
ad1
OptiM
AL-I
T 71
0024
3Op
tiMAL
-IT
7100
24
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.1
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
t W
56-C
(4.0
mm
)3
One
Step
Mal
aria
P.f.
/Pan
Who
le B
lood
Tes
tW
56-C
2On
e St
ep M
alar
ia P
.f Te
stb
W37
-C (4
.0m
m)
3, 4
One
Step
Mal
aria
P.f
Test
W
37-C
ICT
Diag
nost
ics
(R &
R M
arke
ting
)1
ICT
Mal
aria
Com
bo C
asse
tte
Test
M
L02
3, 4
ICT
Diag
nost
ics
Mal
aria
Com
boM
L02
1IC
T M
alar
ia P
f Cas
sett
e Te
st
ML0
13
ICT
Diag
nost
ics
Mal
aria
P.f
ML0
1In
Tec
Prod
ucts
, Inc
.1
ADVA
NCE
D QU
ALIT
Y™ O
ne S
tep
Mal
aria
(p.f.
) Tes
t (w
hole
blo
od)
ITP1
1002
TC40
3 A
dvan
ced
Qual
ity™
One
Ste
p M
alar
ia P
.f Te
stIT
P110
02 T
C40
Orch
id B
iom
edic
al S
yste
ms
1Pa
rach
eck
Pf R
apid
test
for P
. fal
cipa
rum
Mal
aria
(Dev
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 17
2.1. introduction
TheWorldHealthOrganizationestimatesthathalftheworld’spopulationisatriskofmalaria,withanestimated216millionpeople(range149–274million)developingclinicalmalariain2010(81%inAfrica),and655,000deaths(range537,000–907,000)duetomalaria(91%inAfrica,mostbeingchildren).Malariaremainsendemicin106countries,andwhileparasite-baseddiagnosisis increasing,mostsuspectedcasesofmalariaarestillnotproperlyconfirmed,resultinginover-useofanti-malarialdrugsandpoordiseasemonitoring(1).
WHOrecommendsthatmalariacasemanagementbebasedonparasite-baseddiagnosisinallcases(2).Theuseofantigen-detectingrapiddiagnostictests(RDTs)formsavitalpartofthisstrategy,byprovidingthepossibilityofparasite-baseddiagnosisinareaswheregoodqualitymicroscopycannotbemaintained.ThenumberofRDTsavailable,andthescaleoftheiruse,hasrapidlyincreasedoverthepastfewyears.However,limitationsofcomparativefieldtrialsandtheheterogeneousnatureofmalariatransmissionandepidemi-ologyhaslimitedtheavailabilityofgoodqualityperformancedatathatnationalmalariaprogrammesrequiretomakeinformeddecisionsonprocurementandimplementation,andlimitstheabilitytoextrapolateresultsoffieldtrialstodifferentpopulationsandtimeperiods.Tothisendin2006,theWorldHealthOrganization(WHO),theSpecialProgrammeforResearchandTraininginTropicalDiseases(TDR)andtheFoundationforInnovativeNewDiagnostics(FIND)launchedanevaluationprogrammetoassessthecomparativeperform-anceofcommerciallyavailablemalariaRDTs.Currently,thesedataareguidingprocurementdecisionswhichareinturn,shiftingmarketstowardsbetterperformingtestsandhelpingtodriveoverallimprovementinthequalityofmanufacturing.TheresultsofWHOMalariaRDTProductTestinghavebeenpublishedannuallysince2009andpresentlyformthebasisofprocurementcriteriaoftheWHO,otherUNagencies,theGlobalFundandnationalgovernments(3).ThisReportprovidesdataonRound4ofProductTesting,performedattheUnitedStatesCentersforDiseaseControlandPrevention,DivisionofMalariaandParasiticDiseases(CDC)in2011-2012.Itprovidesperformancedataon48products.ThisevaluationshouldbeseenasadditivetoRounds1-3evaluations(3-5).Thefourreportsshouldbeviewedtogetherasasingleevaluation,withtheexceptionthatwhereproductstestedinpreviousroundshavebeenre-submittedfortestinginRounds2,3or4,themostrecentresultreplacethosereportedpreviously.Fromroundtoround,theevaluationpanelsareessentially
equivalent1,andthesametestingprotocolsarefollowed.Thisreportexpandsthedatasetfrompreviousrounds,andthereforeincreasesthenumberofRDTsavailableforprocurementthathavedetailedcomparativedataonaspectsofperformancerelevanttofielduse.
2.2. the WHo product testing programmeProductTestingispartoftheWHO-FINDMalariaRDTEvaluationProgramme.Thisprogrammedevelopsmethodsforevaluationandprovidesrelevantdataonantigen-detectingmalariarapiddiagnostictests.Theprogrammeisacollaborationofmanyinstitutionsinmalaria-endemicandnon-endemiccountries,withtheglobalspecimenbankmaintained,andthetestingperformed,atCDC(Figure2).
AllcompaniesmanufacturingunderISO13485:2003QualitySystemStandardwereinvitedtosubmituptotwotestsforevaluationundertheprogramme.The44productsand4co-listedproductsfrom27manufacturers2wereevaluatedagainstpreparedbloodpanelsofculturedPlasmodium falciparumparasitesandpatient-derived,wild-typeP. falci-parumandP. vivaxparasites,andaparasite-negativepanel.Thermalstabilitywasassessedaftertwomonthsofstorageatelevatedtemperatureandhumidity,andadescriptiveease-of-useassessmentwasrecorded.Asinpreviousrounds,RDTsaregroupedintheresulttablesandfiguresintothosedetectingP. falciparum only,variouscombinationtests,andthosethathaveonlyapan-specific(orP. vivax-specific)line.Manufacturerssubmittedtwolotsofeachproductforevaluation.
Theevaluationisdesignedtoprovidecomparativedataontheperformanceofthesubmittedproductionlotsofeachproduct.SuchdatawillbeusedtoguideprocurementdecisionsofWHOandotherUNagenciesandnationalgovern-ments.ProducttestingispartofacontinuingprogrammeofworktoimprovethequalityofRDTsthatareused,andtosupportbroadimplementationofreliablemalariadiag-nosisinareaswheremalariaisprevalent.Afifthroundof
1 http://www2.wpro.who.int/sites/rdt/who_rdt_evaluation/(accessed10October2012)
2 SeveralmanufacturersaresubsidiariesofAlere™andtwocompanies(AccessBio,EthiopiaandMedisenor,Inc)sellre-brandedproductsmanufacturedbyAccessBio,Inc(Table1).Thesere-branded/jointlistedproductswereactuallynotevaluatedastheyareidenticaltoCareStart™MalariaHRP2/pLDH(Pf/Pv)COMBO(G0161)andCareStart™MalariaHRP2/pLDH(Pf/VOM)COMBO(G0171)
2. WHo Malaria rdt prodUct testing: roUnd 4 eXecUtiVe sUMMarY
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)18
producttestingwillbegininJanuary2013,andresultswillbepublishedin2014.
2.3. results of the evaluation Theresults(summarizedinTables3,4,5andFiguresS1andS2)providecomparativedataontwolotsofproductsagainstapanelofparasitesamplesdilutedtoalowparasitedensity(200parasites/µl),consideredclosetothethresholdthattestsmustdetecttoreliablyidentifyclinicalmalariainmanysettings(6),andahigherparasitedensity(2000(or5000)parasites/µl).Forthepurposesofthisreport,themainmeasureofperformanceisthe‘paneldetectionscore(PDS)’;thepercentageofmalariasamplesinthepanelgivingaposi-tiveresultbytwoRDTsperlotatthelowerparasitedensity,andasingleRDTperlotatthehigherparasitedensity.Thus,itisnotameasureofRDTclinicalsensitivity,orpositivityrateagainstthepanelbutratheracombinedmeasureofpositivityrate,alongwithinter-testandinter-lotconsistency.
ConsistentwiththeperformanceofproductsincludedinpreviousroundsofProductTesting,thePDSvarieswidelybetweenproducts,withsomeproductsshowinghighperform-anceindetectingparasites,inthermalstabilityandotherperformancemeasures.Overall,thereisnoobvioustrade-offseenbetweenPDS(orpositivityrate)andfalse-positiverate,thesebeingsurrogatesforsensitivityandspecificityinthefield,respectively.Furthermore,anumberoftestsshowedgoodoutcomesonbothoftheseindicators.Sixtyninepercent(9/13)ofthere-submittedproductseithermaintainedorimprovedtheirPDSandoveralltherewasameanincreaseinP. falciparumPDSof3.7.AgainsttheP. vivaxpanels,themeanPDSincreasewas13.4.However,forcombinationtests,someimprovementsinP. falciparumorP. vivaxdetectionwereassociatedwithdecreasesinthePDSfortheother.AfewproductshaveveryhighP. falciparumfalse-positiveratesagainstclean-negativesand,aspreviouslyreported,highfalse-positiveratesareseenforseveralproductsagainstthebloodsamplescontainingspecificimmunologicalabnormalities(e.g.rheumatoidfactor,anti-mouseantibodies).However,thenumberofsamplesevaluatedwassmallandtheclinicalsignificanceoftheseresultsislimited,butmaybecomeimpor-tantincertainpopulationswithverylowparasiteprevalence.Someproductsshowavariationinperformanceindicatorsbetweenthetwolotsevaluated,underliningtheadvisabilityoflot-testingbeforefielduse.Heat(thermal)stabilityvarieswidely,withsomeproductsretaininghighpositivityratesaftertwomonthsstorageat45ºCin75%humidity.Formanyproducts,pan-lineperformanceatbaselineandpost-heatstressfordetectionoftheP. falciparumisolateispoor,andnearlyuniversallypooragainstlowparasitedensitysamples,makingtruestabilitydifficulttoassess.
TheclinicalsensitivityofanRDTtodetectmalariaishighlydependentonthelocalconditions,includingparasitedensityinthetargetpopulation,andsowillvaryamongpopulationswithdifferinglevelsoftransmission.Theresultsinthis
reportshowcomparativeperformancebetweenRDTs,andgiveanideaofwhichproductsarelikelytoprovidehighersensitivityinthefield,particularlyinpopulationswithlow-densityinfections.Ingeneral,ascountriesreducemalariaprevalenceandevenmovetowardsmalariaelimination,detectionoflowparasitedensitiesbecomesincreasinglyimportantincasemanagement.Asthepaneldetectionscoreat2000parasites/µlindicates,thesensitivityofmanyoftheseproductswillbesimilarinpopulationswithhigherparasitedensities,althoughasubsetofanypopulationwillincludevulnerableindividualswhomaydevelopillnessatlowparasitedensities(e.g.youngchildren,pregnantwomen,thosewellprotectedbybednets)andmustalwaysbetakenintoaccountwheninterpretingRDTresults.
Inareaswheresignificantlevelsofnon-expressionofHRP2areknowntooccur,theresultsofHRP2-detectingtestsgiveninthisreportshouldnotbeconsideredpredictiveoffieldsensitivity.TeststargetingP. falciparum bydetectionofpLDHoraldolaseshouldonlybeconsidered.
Heatstability(summarizedinTable5)isvitaltomaintainingsensitivityofthetestinthefield.Asaresult,forprocurement,itisessentialthatcarefulconsiderationbegiventostabilityresultstoensurethatproductstobeusedinareaswithhightemperaturesduringtransportandstoragehavedemon-stratedgoodstabilityintheproducttestingprogramme.Requirementswillvarybetweencountries:forexample,iftestsaretobedeployedinareaswheretemperaturesrarelyriseabove30°C,lessemphasisneedstobeplacedonstabilityathightemperatures.
Ease-of-userequirementswillalsovary,dependingontheextentoftrainingandtheworkenvironmentoftheend-users.Particularlyinprimaryhealthcaresettings,thesimplerthetests,theeasieritwillbetoavoiderrorsinpreparationandinterpretation.
2.4. Use of these resultsTheresultsincludedinthisreportshouldbeconsideredtogetherwiththoseofpreviousRounds1-3,withtheresultsofre-submittedproductsreplacingthosereportedinearlierrounds(3-5).Ultimately,itisimperativethatprocurementdecisionsbasedontheseresultstakeintoconsiderationlocalconditionsofmalariatransmissionandillnesswherethetestswillbeused(e.g.Plasmodiumspecies,targetantigenvariation,parasitedensities,climate).ProcurementofRDTsmustnotoccurwithoutprogrammaticandinfrastructurepreparationforproperuse,includingsupplychainmanage-ment,trainingontestusageanddisposal,andtrainingonpatientmanagementinresponsetoresults.Thisreportprovidesanalgorithmtoassistinthisdecision-makingprocess(Annex5a).Furthermore,comprehensiveguidanceonseveralaspectsofprocurementcanbefoundin‘Good Practices for selecting and procuring rapid diagnostic tests for malaria’(7).
eXec
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 19
3. backgroUnd
In2011,WHOestimatedthat3.3billionpersonswereatriskofacquiringmalaria.Ofthese,216millionpeople(range149–274million)developedclinicalmalariain2010(81%inAfrica),and655,000died(range537,000–907,000)duetomalaria(91%inAfrica,mostbeingchildren).Malariaremainsendemicin106countries(1).
Inthepastdecade,majornewopportunitiesforthecontrolofmalariahaveemerged, includingimplementationoflong-lastinginsecticidalnets,indoorresidualsprayingofinsecticidesandartemisinin-basedcombinationtherapy(ACT).Thesetoolshavebeenshowntoreducetheburdenofmalariainfectionincountrieswheretheyareadequatelyimplemented.Inturn,theproportionoffebrileepisodesattributabletomalariaislikelytodecreasesubstantially.
DespiteWHOrecommendationsforlaboratory-confirmeddiagnosisofmalariainfectionspriortotreatmentinallcases(2),diagnosisisoftenmadeonclinicalgrounds(6).However,inmostendemicareasmalariamakesupaminorityof‘malaria-like’febrileillness.Microscopyhasbeenthecornerstoneofdiagnosisandisrecommendedformalariadiagnosiswhereitsqualitycanbemaintained;however,theneedfortrainedpersonnel,adequatereagentsand
equipment,limititsavailabilityandaccessibilitytomanypeopleinmalaria-endemicareas.Rapid,accurateandacces-siblediagnostictoolsarebecomingincreasinglyimportant,asprogrammesexpandparasite-baseddiagnosisandtheprevalenceofmalariadecreases.Inrecentyears,rapiddiagnostictests(RDTs),whichdetectPlasmodium-specificantigens(proteins)inwholebloodofinfectedpeople,haveemergedasanattractivealternativetomicroscopy.CurrentlyavailableRDTscomeinvariousformats(dipstick,cassetteorcard)andcontainboundantibodiestospecificantigenssuchashistidine-richprotein-2(HRP2)(specifictoP. falci-parum),pan-specificorspecies-specificplasmodiumlactatedehydrogenase(pLDH)oraldolase(specifictoallthemajorPlasmodiumspecies:P. falciparum,P. vivax,P. malariae,P. ovale(Figure1).
Tobewidelyuseful,aRDTmusthavehighsensitivitytoensureallclinically-significantmalariainfectionsaredetected;highspecificitytoenablemonitoringoflowmalariaprevalenceandappropriatemanagementofnon-malarialfever;andhighstabilitytoallowtransportandstorageinambientconditionsinmalaria-endemicareas.PublishedfieldtrialsofRDTsshowhighvariabilityinperformance,likelyduetoinadequatequalityofmanufacture,incorrectstorageandhandling,poorpreparationandinterpretation,andsometimespoorstudymethods,analysisandreporting(8-16).Ingeneral,diagnostictesting(bymicroscopyorRDT)toalevelof200parasites/µlwillreliablydetectnearlyallclinicallyrelevantinfectionsinmalaria-endemicareas(6).
Figure 1: Mode of action of antigen-detecting malaria RDTs
a
b
c
Bound Ab
Free labelledAb
Captured Ag–labelledAb complex
Capturedlabelled Ab
Parasite Agcaptured bylabelled Ab
Labelled Ab–Agcomplex capturedby bound Ab oftest band
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ModeofactionofcommonmalariaRDTformat:
(a)Dye-labeledantibody(Ab),specificfortargetantigen, is present on the lower end of thenitrocellulosestriporinawellprovidedwiththestrip.Antibody,alsospecificforthetargetantigen,isboundtothestripinathin(test)line,andeitherantibodyspecificforthelabeledantibody,orantigen,isboundatthecontrolline.
(b)Bloodandbuffer,whichhavebeenplacedonthestriporinthewell,aremixedwiththelabeledantibodyandaredrawnupthestripacrossthelinesofboundantibody.
(c)Ifantigenispresent,somelabeledantibodywillbetrappedonthetestline.Otherlabeledantibodyistrappedonthecontrolline.
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)20
ThenumberofRDTsavailableonthemarkethasgrownrapidlysincetheirintroductioninthelate1990s.Itisestimatedthatthereare60brandsandover200testscommerciallyavailabletoday,withanestimated155milliontestsormorefinancedin20111,2.However,regulatoryoversightofdiagnosticsisoftenweak,andprocurementagencieshavefacedconsiderableproblemsinselectingappropriateRDTsandensuringquality.Inviewoftheinconsistencyinfieldstudyresultsandtheinherentdifficultiesinassessinglargenumbersofproductsinastandardizedwaythroughfieldtrials,WHOandvariouspartnersembarkedonaMalariaRapidDiagnosticTestProductEvaluationProgrammein2002todevelopandemploystandardizedassessmentofmalariaRDTperformance,andtoguideprocurementdecisionsandregulatorymechanisms.TheProgrammehasbeenoverseenbyWHOandTDRinpartnershipwithFIND,andhasbeenguidedbyaSteeringCommitteeandtechnicalconsultationsfrom2003to2012overseeingthedevelopmentofstandardoperatingprocedures(SOPs)fortheprogramme(17, 18).
1 Tracking Progress in Scaling-Up Diagnosis and Treatment for Malaria.Geneva.2009.RollBackMalariaPartnership.
2 J.Cunningham,unpublisheddata.
AnetworkofspecimencollectionsiteswasestablishedtocontributespecimenstoaglobalbankattheCDCandtofacilitatelocalqualitycontrolactivities(Figure2).
Thereportsofthefirst,secondandthirdroundsofProductTestingwerereleasedin2009,2010and2011,respectively(3–5).Thisfourthreportaddsperformancedataon35newproductsandupdateddataon13re-submittedRDTs.TestingforRound4wasconductedagainstanevaluationpanelwithsimilarcharacteristicsintermsofoverallantigenconcentration,parasiteorigin,andparasite-negativebloodsamples,topreviouspanels3.Themajorityofpanelsampleswereretainedfrompreviousrounds.TheresultsshouldbeconsideredtogetherwiththosefromRound1–3(3–5).
3 http://www2.wpro.who.int/sites/rdt/who_rdt_evaluation/(accessed10October2012)
Figure 2: Network of specimen collection, characterization and testing sites
Countries or areas where malaria transmission occursCountries or areas with limited risk of malaria transmissionNo malaria
Malaria, countries or areas at risk of transmission, 2009
This map is intended as a visual aid only and not as a definitive source of information about malaria endemicity.Source: © WHO 2010. All rights reserved.
Collection and testing siteSpecimen characterization
Global specimen bank
QIMR
UCADKEMRIEHNRIEHNRI
CDC
HTD
CIDEIM
IMT IHRDCIPM
DRMIPCIPBIPB
RITM
UL
Abbreviations:CDCCentersforDiseaseControlandPrevention(Atlanta,UnitedStatesofAmerica);CIDEIMCentroInternacionaldeEntrenamientoyInvestigacionesMédicas(Cali,Colombia);DMRExperimentalMedicineResearchDivision(DepartmentofMedicalResearch,Yangon,Myanmar);EHNRIEthiopianHealthandNutritionResearchInstitute(AddisAbaba,Ethiopia);HTDHospitalforTropicalDiseases(London,UnitedKingdomofGreatBritainandIreland);IHRDCIfakaraHealthResearchandDevelopmentCenter(Bagamoyo,TheUnitedRepublicofTanzania);IMTInstitutodeMedicinaTropical(UniversidadPeruanaCayetanoHeredia,Lima,Peru);IPBInstitutPasteurdeBangui(Bangui,CentralAfricanRepublic);IPCInstitutPasteurduCambodge(PhnomPenh,Cambodia);IPMInstitutPasteurdeMadagascar(Antananarivo,Madagascar);KEMRI:KenyaMedicalResearchInstitute(Kisumu,Kenya);QIMRQueenslandInstituteofMedicalResearch(Brisbane,Australia);RITMResearchInstituteofTropicalMedicine(Manila,ThePhilippines);UCAD:UniversitéCheikhAntaDIOP(Dakar,Senegal);ULUniversityofLagos(Lagos,Nigeria).
Me
tHo
ds
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 21
4. objectiVe
TheobjectiveoftheprogrammeistoevaluatemalariaRDTstoproduceperformancedatatoguideprocurementofRDTsforuseinthefieldinmalaria-endemiccountries.
5. Materials and MetHods
5.1. test selection InDecember2010,theWHO-FINDMalariaRDTEvaluationProgrammeissuedacallforexpressionofinteresttomanu-facturersofmalariaRDTsalongwithinformationregardingtherequirementsforsubmissionofaproducttoRound4andtheconditionsforparticipationintheEvaluationProgramme1.Requirementsincluded:validISO13485:2003certificationfromallmanufacturingsites,supplyofsufficientquantitiesofproducts(1100testsfromeachof2lots),compliancewiththeproductdefinition2anddeadlinesfordocumentsubmission.
Thirtymanufacturers,including82products,respondedtothecall.Inordertokeeptoscheduleandbudget,manufacturerswereaskedtolimittheirproductsubmissionstotwo.ThefinalnumberofproductsincludedinRound4was48,including4jointlistedproducts3.Basedoncataloguenumbersandverificationwithmanufacturers,13ofthe48products(27%)werepreviouslysubmittedtooneormorerounds(TableS3).AfterinitialevaluationagainsttheP. falciparumculture-derivedpanel(Phase1),twoproductsdidnotmeetminimumperformancerequirements4andthereforedidnotproceedtothefullevaluation.
Insummary,ofthe46productsfullyevaluated:10aredesignedtodetectP. falciparumalone,35todetectanddifferentiate
1 http://www.wpro.who.int/sites/rdt/who_rdt_evaluation/call_for_testing_round4.htm
2 WorkingdefinitionofaproductcanbefoundhereinAnnex2:http://www2.wpro.who.int/NR/rdonlyres/2E4CFDF2-90BC-433C-B22D-7E42634EABB7/0/EOIAnnex1_2_3_Round4final171210.pdf(accessed10October2012)
3 SeeTable14 PDS>80%againsthighdensity(2000p/µl)P. falciparumculture
samples
P. falciparumfromnon-P. falciparummalaria,aswellasP. falciparumandP.vivaxorP. vivax, ovale, malariae(vom)-specific,and1todetectP. falciparumandnon-P. falciparummalariawithoutdistinguishingbetweenthem.Annexes1and2provideacomprehensiveoverviewofproductcharacteristics.
5.2. outline of the product testing protocol ThetestingprocessisoutlinedinFigure3andintheMethods Manual for Product Testing of Malaria Rapid Diagnostic Tests - Version 5(17).Inbrief,RDTsfromeachoftwolotsofeachproductwereevaluatedagainstapanelofparasite-positiveandparasite-negativecryo-preservedbloodsamples,andapanelofparasite-negativesamples.Bothlotswerealsotestedforheat(thermal)stability,evaluatedbeforeandaftertwomonths’storageat4°C,35°Cand45°C.Finally,anease-of-usedescriptionwascompletedusingastandardassessmentformat.
ThetestingprocessandallresultswereoverseenbytheWHO-FINDMalariaRDTEvaluationProgrammeSteeringCommittee,andmanufacturersweregiven60daystocommentonindividualproductresultspriortopublication.
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)22
Table 1: Manufacturers and products accepted into Round 4 of WHO Malaria RDT Product Testing Programme
Manufacturer Product Name Catalogue Numbera Target antigen(s)
ABON Biopharm (Hangzhou) Co. Ltdb
ABON™ Malaria P.f. Rapid Test Device (Whole Blood) IMA-402 HRP2
ABON™ Plus Malaria P.f/Pan Rapid Test Device (Whole Blood) IMA-T402 aldolase HRP2
Access Bio, Inc.CareStart™ Malaria HRP2/pLDH (Pf/Pv) COMBOc G0161 pvpLDH HRP2
CareStart™ Malaria HRP2/pLDH (Pf/VOM) COMBOc G0171 pvompLDH HRP2
Access Bio EthiopiaParaCare Malaria HRP2/pLDH (Pf/Pv) COMBOd G0161 pvpLDH HRP2
ParaCare Malaria HRP2/pLDH (Pf/VOM) COMBOe G0171 pvompLDH HRP2
Advy Chemical Private Limited (Affiliate of Bharat Serums & Vaccines Ltd. )
EzDx™ Malaria Pan/Pf Rapid Test Detection kit RK MAL 001 panpLDH HRP2
Artron Laboratories Inc.Trusty™ Malaria Antigen P.f. test A03-11-322 HRP2
Trusty™ Malaria Antigen P.f./p.v. test A03-12-322 pvpLDH HRP2
AZOG, INC.
AZOG Malaria pf (HRPII)/pf (LDH)/ (PAN-LDH) Antigen Detection Device MFV-124F panpLDH pfpLDH HRP2
AZOG hCG Malaria Detection Test Device MPT-124 hCGHRP2, pf-pLDH, panpLDH
Bhat Bio-Tech India (Pte.) Ltd.
Maleriscan ® Malaria P.f Antigen Test MAT-PF-50 HRP2
Maleriscan® Malaria P.f/PAN (Pv, Pm, Po) 3 Line Antigen Test MAT-PF/PAN-50 panpLDH HRP2
Bioland Ltd. NanoSign Malaria pf/pan Ag c RMAP10 panpLDH HRP2
Blue Cross Bio-Medical (Beijing) Co., Ltd.
One Step Malaria P.F Test (Cassette) c 522352 HRP2
One Step Malaria P.F/P.V Test (Cassette) 523352 pvpLDH HRP2
Core Diagnostics Ltd. Core Malaria Pan Pf MAL-190024 panpLDH HRP2
CTK Biotech, Inc.OnSite Pf/Pv Ag Rapid Test c R0112C HRP2 pvpLDH
OnSite Pf/Pan Ag Rapid Test c R0113C HRP2 panpLDH
Formosa Biomedical Technology Corp. MeDiPro Malaria Ag HRP2/pLDH Combo IR-0051K panpLDH HRP2
Genomix Molecular Diagnostics pvt.Ltd.
Malaria Pf/Pv GM002 pvpLDH HRP2
Malaria Pf/ PAN GM004 panpLDH HRP2
Guangzhou Wondfo Biotech Co. Ltd. Wondfo One Step Malaria P.f Test c W 37-C HRP2
HBI Co., Ltd.HiSens Malaria Ag P.f/P.v Combo Card HR3123 pvpLDH HRP2
HiSens Malaria Ag P.f/VOM Combo Card HR3323 pvompLDH HRP2
Hema Diagnostic Systems, LLC
RAPID 1-2-3® HEMA EXPRESS® MALARIA PF/PV TEST MAL-PFV-0207 pvpLDH HRP2
RAPID 1-2-3® HEMA CASSETTE MALARIA PF/PV TEST MAL-PFV-CAS/25(100) pvpLDH HRP2
Humasis, Co., Ltd.Humasis Malaria P.f/Pan Antigen Test AMAL-7025 panpLDH HRP2
Humasis Malaria P.f/P.v Antigen Test AMFV-7025 pvpLDH HRP2
ICT INTERNATIONALICT MALARIA COMBO c ML02 HRP2 aldolase
ICT MALARIA P.F. ML04 pfpLDH
IND Diagnostics Inc.IND ONE STEP MALARIA ANTIGEN P.f/Pan TEST 535-10 panpLDH HRP2
IND ONE STEP MALARIA ANTIGEN P.f 535-11 HRP2
Medisensor, Inc. Medisensor Malaria HRP2/pLDH (Pf/PV) COMBOd M161 pvpLDH HRP2
Medisensor Malaria HRP2/pLDH (Pf/VOM) COMBOe M171 pvompLDH HRP2
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 23
Manufacturer Product Name Catalogue Numbera Target antigen(s)
Orchid Biomedical Systems (Tulip Group)
Paracheck® Pf-Rapid Test for P. falciparum Malaria Device (Ver.3)c 30301025 HRP2
Paracheck® Pf-Rapid Test for P. falciparum Malaria Dipstick (Ver.3)c 30302025 HRP2
RapiGen inc. BIOCREDIT Malaria pf(HRP II) HR0100 HRP2
Span Diagnostics Ltd.
ParaHIT - Total Ver. 1.0 Rapid Test for P. falciparum and Pan malaria species (Dipstick) 55IC203-10 aldolase HRP2
ParaHIT - Total Ver. 1.0 Rapid Test for P. falciparum and Pan malaria species (Device) 55IC204-10 aldolase HRP2
Standard Diagnostics Inc.b SD BIOLINE Malaria Ag Pf/ Pan 05FK66 panpLDH HRP2
SD BIOLINE Malaria Ag Pf/ Pf/ Pv 05FK100 pvpLDH pfpLDH HRP2
Unimed International Inc.FirstSign™ Malaria Pf 2100CB-25 HRP2
FirstSign™ ParaView (Pan+Pf)c 2101CB-25 panpLDH HRP2
United Biotech, Inc.
Malaria pf (HRP II)/PAN (pLDH) Antigen Detection Test Device 1-13-101-1 panpLDH HRP2
Malaria pf (HRP II) / pv (pLDH) Antigen Detection Test Device 1-13-101-3 pvpLDH HRP2
Zephyr BiomedicalsFalciVax™ - Rapid test for Malaria Pv/Pf c 50300025 pvpLDH HRP2
Parascreen® - Rapid test for Malaria Pan/Pf c 50310025 panpLDH HRP2
Pf, P. falciparum Pv, P. vivax Pvom, P. vivax, ovale, malariae HRP2, histidine-rich protein 2 pLDH, Plasmodium lactate dehydrogenasea The same products may have different catalogue numbers to reflect box sizes and/or kit contents. Usually this involves the end portion of the product code. Please
contact manufacturers for details b Alere subsidaries c These products have also been submitted to previous rounds of WHO Malaria RDT Product Testing (Round 1-3). For details on all product resubmissions refer to Table S3.d These products are joint listed (manufactured under identical conditions) with CareStart™ Malaria HRP2/pLDH (Pf/Pv) COMBO (G0161, Access Bio, Inc.)e These products are jointed listed (manufactured under identical conditions) with CareStart™ Malaria HRP2/pLDH (Pf/VOM) COMBO (G0171, Access Bio, Inc.)
Figure 3: Malaria RDT Product Testing Overview
PANEL DETECTION SCOREAND FALSE POSITIVE RATE
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)24
5.3. evaluation panelsRDTswereevaluatedagainstthreepanels,specifically:i) P. falciparumculturelines(includesasubset,‘manufac-
turer’spanel’)atlow(200parasites/µl)andhighparasitedensities(2000parasites/µl).
ii) Wild-typePlasmodiumspecies(P. falciparum,P. vivax)fromnaturallyinfectedhumansandparasite-negativesamplesatlow(200parasites/µl)andhighparasitedensities(2000(or5000)1parasites/µl).AllsamplesarepreparedfromisolatesthatexpressHRP2.
iii) Parasite-negativepanel(‘clean’samplesanddisease-specificorbloodfactor-specificsamples).
Anoverviewofthesamplecollectionandcharacterizationprocesscanbefoundinthemethodsmanualsdevelopedforthispurpose(17-18).CharacterizationresultsforeachRound1-4canbefoundontheWHO/WPRORDTandFINDwebsites.2
Insummary,eachpanelspecimenwascharacterizedfor:i) Speciesbyduplicatemicroscopy(twomicroscopists)and
confirmationbynestedPCRofmono-speciesinfection
ii) Antigenconcentration,determinedbyquantitativeELISAforHRP2,pLDH,aldolase
iii) PCRformalariaandconfirmatorytestingforotherpathologyinthecaseofparasite-negativesamples
Mostsamplesintheglobalspecimenbankarealsocharacter-izedaccordingtoHRP2sequencebyPCRamplification.Thisisnolongerperformedonsamplescollectedafter2009,as
1 5(5%)ofthe98P. falciparumdilutionsamplessetswere200and5000parasites/µland1(3%)ofthe34P. vivaxdilutionsamplesetswere200and5000parasites/µl
2 http://www.wpro.who.int/sites/rdt/who_rdt_evaluation/call_for_testing_round4.htm;http://www.finddiagnostics.org/
accumulatedevidenceindicatesnosignificanteffectonRDTsensitivity(19).Allsampleshavetheirgeographicaloriginrecorded.
panel composition
P. falciparum-cultured parasites panel
Twentyculture-adaptedstrainsofP. falciparumofvariedgeographicaloriginwereselected,including15strainswithtypeBHRP2sequence,threewithTypeA,andtwowithTypeCHRP2sequence.AllspecimenswerederivedfromtheCDCculturebank,anddilutedinOpositiveUSAdonorblood(17).
Table 2: Characteristics of Plasmodium spp. negative samples
Nature of negative samplea No.
Clean-negativeb 58
Anti-nuclear antibody positive (sera) 13
Anti-mouse antibody positive (plasma) 3
Rheumatoid factor positive (whole blood and sera) 4
Rapid plasma reagin positive (sera) 5
Chagas' disease antibody positive (plasma) 2
Dengue antibody positive (whole blood sera) 4
Leishmaniasis antibody positive (sera) 5
Schistosomiasis antibody positive (whole blood and sera) 6
a Whole blood unless indicated. Sera and plasma samples were reconstituted packed cells
b Healthy volunteers with no known current illness or blood abnormality
Figure 4a: Origin of Phase 2 P. falciparum wild type (clinical) samples (n=98)
Figure 4b: Origin of Phase 2 P. vivax wild type (clinical) samples (n=34)
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Wild-type parasite panel
Theparasite-positivewild-type(clinical)panelconsistedofsamplesfrom98casesofP. falciparumand34casesofP. vivax,derivedfrom12collectionsitesinAsia,AfricaandSouthAmerica(Figures2,4aand4b).
Sampleswerecollectedfromfebrilepatientsandprocessedaccordingtostandardizedmethodsdesignedtopreservetargetantigenconcentration (18).Afterdilutionsandcryo-preservation,samplesweretransferredtotheglobalbank(WHOSpecimenBank)atCDCforfurthercharacterization.ThedistributionofconcentrationofHRP2,aldolaseandpLDHweredeterminedonalargersampleduringthefirstroundofproducttestingin2008,andatestpaneldevelopedforthatroundthatexcludedsampleswithextremesofhighorlowantigenconcentration.Panelsforsubsequentrounds,includingRound4,havebeenmaintainedwithintheseparameters.
Negative blood samples
Thenegativepanelconsistedof‘clean’parasite-negativesamplesfromdonor-derivedbloodobtainedinbanksorfromvolunteersinnon-endemic(USA)andendemicareas(ThePhilippines,Madagascar,Senegal,NigeriaandKenya),havingbeenmalaria-negativebymicroscopy.Thepanelfurthercontainsparasite-negativesamplesfromdonorswithdiseasesthatmaypotentiallybeinthedifferentialdiagnosesofmalaria,orcontainspecificbloodfactorsknowntobecommoninthecommunityorknowntohavethepotentialtocausefalse-positivereactionsonimmunochromatographictests(Table2).AllnegativecontrolsampleswereconfirmedtobefreeofPlasmodiumparasitesbyPCRamplification.
Furtherdetailsoftheculture,wild-typeandparasite-negativepanelscanbefoundat http://www.wpro.who.int/NR/rdonlyres/62AA6F12-638E-4C1E-B7CC-10014B2273CA/0/RndFourProdTestEvalPanel_Pub.pdf.
5.4. rdt registrationThereceiptofeachshipmentofRDTsattheCDCwasrecordedinadedicatedRDTregister.Temperaturemonitoringdeviceswereofferedtomanufacturersfreeofcharge,toaccom-panyRDTsshipmentstoCDC.AllRDTswerestoredinroomtemperatureat≤25°Cimmediatelyandtemperaturemoni-torswerelabelledwithreceiptdateandforwardedfordownloading,whenapplicable.
5.5. specimen panel registrationAllpanelspecimenswereassigneduniqueidentificationnumbersatthecollectionsitesandstoredinaliquotsof50µLat-70°Cuntilthetimeoftesting.Alldatapertainingtospecimenidentification,storagelocationandcharacterizationresultsarestoredinasecure,dedicateddatabase.
5.6. test phasesTheevaluationwasdividedintotwotestingphases:
Phase 1 -AscreeningsteptoallowtheselectionofRDTsmeetingminimalqualityrequirements.Productsfromtwolotswereevaluatedagainstapanelof20culture-derivedP. falciparumsamplesathigh(2000parasites/µl)andlow(200parasites/µl)parasitedensities.Toprogresstothefullevaluation(Phase2),aproductevaluatedinPhase1mustachieveaminimum80%paneldetectionscore(PDS)againstthe2000parasites/µlsamples(Figure6).
Phase 2 -Productsfromtwolotswereevaluatedagainstapanelofdilutedclinicalbloodsamplescontainingwild-typeparasitesandaparasite-negativepanel,evaluatedforheat(thermal)stability,andassessedforease-of-use.
a. Themixedparasite-positiveandparasite-negativepanelwascomprisedof98P. falciparum,34P. vivaxattwoparasitedensities(200parasites/µland2000(or5000)1parasites/µl),and100parasite-negativecontrols.
b. Heatstabilityevaluation:Baselinetestingof15RDTsfromeachoftwolotsagainstasingleculture-derivedP. falci-parumisolate(NigeriaXIIstrain,PfHRP2sequencetypeBwithatypicalantigenconcentration)at200parasites/µland5RDTsfromeachlotat2000parasites/µl,and4RDTsfromeachlotagainstanegativesample.ThisprocedurewasrepeatedafterRDTsweremaintainedfor60daysat4°C,35°Cand45°Cat75%humidity.
c. Ease-of-useassessment:Afterbecomingfamiliarwiththetestdevice,techniciansjointlydescribedthetestforbloodsafetycharacteristics,qualityofinstructions,numberoftimedstepsandtotaltimetoresult,usingastandardreferenceguide (17).
5.7. performing rapid testsAllRDTswerebroughttoroomtemperaturepriortofirstuse.Desiccantwasinspectedforcolourchangesandproductswerediscardediftheywerepresent.RDTswerelabelledwithsampleidentificationnumber,dilution,andthedatewhentestwasperformed.Performanceofrapidtestswasinaccord-ancewithmanufacturer’sinstructions,withtheexceptionthatbloodtransferwascarriedoutbymicro-pipettefromthesampletube.Theresultwasrecordedbyatechnicianattheminimumspecifiedreadingtime.Asecondtechnicianre-readtheresultwithin1hourforinternalmonitoringpurposesandforinformationformanufacturers.Technicianswererotated,andblindedtosampletypeandtoeachother’sresultsduringPhase2.Annexes1and2containadescriptiveandillustratedsummaryofthetestcharacteristics,stepsandguidetointerpretationofresults.
1 Five(5%)ofthe98P. falciparumdilutionsamplessetswere200and5000parasites/µland1(3%)ofthe34P. vivaxdilutionsamplesetswere200and5000parasites/µl
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)26
5.8. interpretation of resultsResultsofcontrolandtestlineswererecordedasnegativeorpositivebyeachtechnician.Eachtestwasreadagainstastandardcolourchartandthebandintensitygradedas0(novisibleband),1,2,3or4.Ifthecontrollineisrecordedasabsentbyeithertechnician,thetestisrecordedasinvalid.
Figures5and6illustratethetestingsequenceatlowandhighparasitedensities.
Figure 5: Testing procedure and calculation of ‘panel detection score’ and band intensity for Product A against a sample density of 200 parasites/µlThefirstreadingwasattheminimumtimespecifiedbythemanufacturer;thesecondreadingwasuptoonehourlatera.Asampleisconsidereddetectedonlyifallfirsttestreadings,frombothlots,arepositiveie.Readingsa,b,canddmustbepositive.
Product A
c dReading
1Reading
1Reading
2Reading
2
Lot 2
Test 3 Test 4
a bReading
1Reading
1Reading
2Reading
2
Lot 1
Test 1 Test 2
Detected if 4 positive
first-readings
Basedonthepositiveresultsoffirsttestreading(2testsperlot),themeanbandintensityscore=a+b+c+d/4(excludingnegativeresults).
a second reading results are for internal use only
Figure 6: Testing procedure and calculation of ‘panel detection score’ and band intensity for Product A against a sample density of 2000 parasites/µl Thefirstreadingwasattheminimumtimespecifiedbythemanufacturer;thesecondreadingwasuptoonehourlatera.Asampleisconsidereddetectedonlyifallfirsttestreadings,frombothlots,arepositiveie.Readingsaandbmustbepositive.
Product A
aReading
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Basedonpositiveresultsoffirsttestreading(2testsperlot),ineachlot,themeanbandintensityscore=a+b/2
a second reading results are for internal use only
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6. data ManageMent
ThereceiptofproductswashandrecordedinaRDTregisterattheCDCasperStandardOperatingProcedures(SOPs).DataassociatedwithspecimencollectionandcharacterizationwasrecordedfirstonhardcopyreportformsaspertheSOPsatthecollectionsites(Figure2),HTD(ELISAresults)andCDC(PCRresults)andthenentereddirectlyintoExcelfollowedbyimportationintoaspeciallydevelopeddatabase.
TheresultsoftheproductpaneltestingandheatstabilitytestingconductedattheCDCwererecordedonreportformsbyeachtechnicianindividually,aspertheSOP.Theseresultsweredouble-dataentered,andanalysedfordiscrepancies.
Allsourcedocumentsandelectronicrecordsofstudydataaremaintainedinsecurestorageuntiltheconclusionoftheevaluation,dataanalysisandreportpublication.
Individualproducttestingreportsweredistributedtomanu-facturers’on3September2012,fora60dayreviewperiodpriortopublicationofthefinalreport.Rawdataweremadetomanufacturersavailableuponrequest.
7. QUalitY assUrance
ProducttestingfollowsSOPsdevelopedthroughpriortestingexperienceandarebasedonrecommendationsofexpertconsultations,withminormodificationsmadeonsuggestionbytheSteeringCommitteepriortoRound4 (17).Inparticular,changesintheSOPsfromthepreviousroundsincludeanincreaseinthenumberofRDTstestedagainst200parasites/µLateachstageofstabilitytestingfrom10to15,whileRDTstestedat2000parasites/µLwerereducedfrom10to5.Overall,thequalityofcriticalstepswascontrolled,asfollows:
i) Quality of the malaria RDTs and their use:AllRDTswerestoredinacontrolledenvironmentatroomtemperatures≤25°C;thepouchwasopenedanddesiccantcheckedimmediatelybeforeuse;manufacturerinstructionswerefollowedwiththeexceptionofuseofthebloodtransferdeviceprovidedbythemanufacturer(amicropipettewasusedtoensurecorrectbloodvolume).
Atemperature-monitoringdevicewasofferedtobeincludedwiththeRDTsforshipmenttothetestingsite(CDC).Logswereanalysedforanytemperaturesbeloworabovemanu-facturersrecommendedstorageconditions.
ii) Quality and objectivity of the RDT reading results:Resultswerereadingoodlightingbytrainedtechnicianstestedforvisualacuity,anddoublyenteredintothedatabase.Technicianswererotated.Readingsofasecondtechnicianwereusedforinternalmonitoringpurposes,andsummarizedresultsreviewedindetailandpotentialdiscrepanciesidentifiedandcross-checkedagainstsourcelaboratoryreportforms.
Allwild-typeparasitesampleswererandomizedwithpara-site-negativesamplesandre-labelledforblindedreadingoftheRDTresults.
iii) Quality of the WHO Specimen Bank samples:SOPswereestablishedforthepreparationofallspecimenbanksamples (18).Culturelinesofparasitesandwild-typesampleswereselectedtakingintoaccountpreviousevidenceanddatafromspecificallyconductedstudies.Alldilutedparasitesampleswerestoredandtransportedat-70°C,andwereusedonlyoncewithin8hoursofthawing.
iv) Quality of the product testing site: TheDivisionofParasiticDiseasesandMalaria(DPDM),CenterforGlobalHealth,CDC,isthemajoroperatingcomponentoftheDepartmentofHealthandHumanServices(HHS)oftheUSAthatdealswithmalariacontrolandpreven-tion.LaboratorieswithinDPDMholdClinicalLaboratoryImprovementAmendments(CLIA)accreditationandaremonitoredbyaninternalqualitymanagementsystems(QMS)program.
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)28
8. etHical considerations
EachspecimencollectionsiteobtainedapprovalfromaWHOResearchEthicsReviewCommitteeand/orlocalinstitutionalreviewboardforspecimencollection,transportandarchivingofbloodsamplesforthepurposeofproducttesting,lottestingandqualityassuranceprocedures.
9. data analYsis
9.1. Measures of parasite detection: panel detection score and positivity ratesMalariaRDTsdetectparasite-derivedantigen.Therelationshipoftheconcentrationofantigenavailablefromthebloodsample(afterlysisofredcellsandparasites)totheperipheralparasitedensityvarieshighlyduetoaseriesofhostandparasitefactors.Inaddition,thepopulationfrequencyofspecificfactorsthatcanresultinfalse-positiveresultsmayvary.Therefore,fieldsensitivityandspecificityofanRDTmaychangeindifferentepidemiologicalsituations.Theevaluationreportedheredoesnotpredictsensitivityorspecificityinagivenfieldsituation.Itreportscomparativedetectionoftargetantigensandfalse-positiveratesofRDTsagainstastandardizedpanel,inacontrolled,repeatablemanner.Asthepanelisdevelopedtobeacloseapproximationoffieldsamples,thecomparativedetectionratesbetweenproductsareexpectedtobereflectedbysimilarcomparativedetectionratesinthefield.AsthepanelisdesignedtoincludealargenumberofsamplesclosetothelimitsofdetectionofRDTs(200parasites/µl),thepanelislikelytodiscriminatemoreclearlythanafieldtrial.Itfollowsthatinsomesettings,suchaswhereparasitedensityisveryhigh,differencesinthepaneldetectionscore(PDS)andpositivityratesbetweentestsobservedagainsttheWHOevaluationpanelmaynotbeobservedinpatientpopulations,ormaybemuchsmaller.Furthermore,whereparasitedensitiesareverylow,detectionratesmaybelowerthanthosereportedhere.
ReferringtoFigure5,aproductmustreturnfourpositivetestresultsatthemanufacturers’recommendedminimumreadingtime(twofromLotOne,twofromLotTwoattheinitialreadingtime)whentestedagainstaparasitedensityof200parasites/µl,tocontributetoitsPDS.Whentestedagainst2000or5000parasites/µl(Figure6)theproductmustreturntwopositivetestsatthemanufacturers’recommendedminimumreadingtime(onefromeachlot).Thus,thePDSisameasureofinter-testandinter-lotconsistency,aswellastheabilitytodetectantigen.ThePDSforP. falciparumindicatesanRDTresultconfirmingthepresenceofP. falciparum, whentestedagainstculturedandwild-typeP. falciparumsamples,whilethenon-P. falciparum PDS(P. vivax detectioninthisReport)indicatesPlasmodium-positive/P. falciparum-negativeresultswhentestedonwild-typeP. vivaxsamples.
Thepositivityrateisthepercentageofalltestsofaparticularproductthatreturnedapositivetestresult,atthemanufac-turers’recommendedminimumreadingtime,whentestedagainstaP. falciparum or P. vivax sample.
9.2. false-positive resultsFalse-positiveresultsareanalysedandreportedastwosepa-rategroups;thosethathadincorrectspeciesidentification,
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andthosethatreturnedapositiveresultforsamplesnotcontainingPlasmodiumspp.parasites.Specifically,thefalse-positiverateisthepercentageofalltestsofaparticularproductthatreturnedapositivetestresultwhenitshouldn’thave,basedonresultsatthemanufacturersrecommendedminimumreadingtime.
9.2.1. incorrect species identificationAtestisconsideredasreturninganincorrectspeciesresultifapositiveP. falciparumtestlineappearsupontestingagainstasamplecontainingnon-P. falciparum (P. vivax)parasites.P. falciparumsamplesresultinginonlyavisiblepan-specific(ornon-P. falciparum-specific)testlineoncombinationtestsarealsoconsideredtobefalse-positives.
9.2.2. false-positives from plasmodium-negative samplesAnytestthatproducesapositivereadingtosampleswithnoPlasmodiumparasitesisconsideredafalse-positive.InPhase2,parasite-negativesamplesconsistofclean-negativesamplesandalsosamplescontainingotherinfectiousagents(e.g.dengue,leishmania,Chagas)andimmunologicalfactors(e.g.rheumatoidfactor,anti-nuclearantibodies,anti-mouseantibodies)(Table2).
9.3. band intensityAllpositivetestresultswererecordedaccordingtothebandintensityagainstastandardreferencechart,matchedcloselytolinecolour.Basedonthefirstreaderresults,thedistributionofbandintensityresultsispresentedasthemeanbandintensityofpositiveresults.Inaddition,theintensitywasexpressedforeachpossibleresult(0,1,2,3or4)asthepercentagerecordedatthatlevel1.
9.4. lot agreement Disagreementbetweentestlotsiscalculatedfromthenumberofsamplesthatreturnedapositiveresulton both RDTstestedinthatlotagainstparasite-positivesamplesat200parasites/µl,andonthesingleRDTfromeachlottestedagainstsamplesat2000(or5000)parasites/µl.Thus,highinter-lotagreementindicatesconsistencyindetectingmalariaparasites.Whereonetestwasinvalidandtheotherpositive,positiveagreementwasrecorded.
1 AstandardintensitycomparisonchartisusedwhichallowsmatchingtotheclosestoffourcommoncolourvariantsoflabelledantibodiesusedonRDTs,eachatfourlevelsofintensity.
9.5. invalid testsThesearethetotalnumberofteststhatweredeemedinvalidduringtestingofbothlots,usingsamplesat200parasites/µland2000(or5000)parasites/µl.
9.6. Heat (thermal) stability TheresultsofheatstabilitytestingarereportedasthenumberofpositivetestsreturnedbasedoneitherReading1orReading2fromtwolotsateachparasitedensity(maximumscore30against200parasites/µlsamples;10against2000parasites/µlsamples)2andmeanbandintensity(forpositivetestsonlybasedoneitherReading1or2)atbaselineandafterlotswerestoredat4°C,35°Cand45°CfortwomonthsagainstoneculturedP. falciparumparasitesampleat200and2000parasites/µl.
2 Fifteentestsperlotagainst200parasites/µlsamplesand5testsperlotagainst2000parasites/µlsamples.Invalidresultswereexcludedfromanalysis.
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)30
10. laboratorY VersUs field-based Malaria rdt eValUations
Despitethestrengthsoftheproducttestingprogramme,theevaluationisnotcompletelyanalogoustofieldtestingofmalariaRDTs.InordertocomposeapanelthatcouldbereproduciblyusedtoevaluateRDTs,bloodsampleswerediluted,frozenandstoredbelow−70°C.Bloodthathasundergoneafreezethawprocessandisthereforelysedmaynothaveexactlythesamecharacteristicsasfreshblood.Afurthervariationfromfieldequivalenceistheuseofamicro-pipettetosupplybloodtotheRDTdeviceratherthanthebloodtransferdeviceprovidedbythemanufacturer.Thiswasnecessarybecausebloodiscollectedfromacryo-tuberatherthanafinger-prick,andthebloodtransferdevicesprovidedwithaparticularproductcanvary(20).Thistech-niquealsoensuredconsistencyoftestingbyreducingthelikelihoodofoperatorerror.AllsamplesinthepanelusedfortheevaluationarepreparedfromparasitesthatexpressHRP2.TheresultswillthereforenotbepredictiveoffieldtrialresultsinvolvingparasitepopulationswithsignificantlevelsofHRP2deletion(21).
Fieldtrialshaveaplaceinproductselection,particularlyindeterminingwhichofashort-listofproductsismostappropriateforthetechniciansandsituationofitsintendedusebyaprogramme(e.g.ease-of-usecharacteristics).Suchtrialsshouldhavecarefullydefinedobjectivesandproceduresdesignedtoachievethese.Trialstodeterminethelikelyfieldsensitivityandspecificityofaproductalsohaveaplace,butrequirelargesamplesizesandpopulationswithlowparasitedensitiestodeterminesignificantdifferencesbetweenwell-performingproducts,theyneedtobetightlycontrolled,andarethereforeexpensive.Theydonotallowcomparisonofalargenumberofproducts.WHOhasproducedrecommendationsongoodpracticeformalariafieldtrialswhichshouldbefollowedtoimprovetherepeatabilityandqualityofresults(22).
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 31
11.1. summaryRound4ofWHOMalariaRDTProductTesting,reportsresultsfor481productsevaluatedagainstP. falciparumculturesamples,andfor46oftheseproductsthatproceededtoevaluationagainstwild-typesamplescollectedfrompara-sitaemicpatientsfromthreecontinentsandalargepanelofparasite-negativesamples.Heatstabilitywasassessedattemperaturescommonlyencounteredinmalariaendemiccountries.Thirteenresearchinstituteshavebeenengagedineithersamplecollectionorsamplecharacterizationtoestablishtheevaluationpanels.BetweenJune2011andMay2012approximately56,000testswereperformedattheCDC.
Theresultsoftheevaluationrevealthefollowingkeyoutcomes:i) TheoverallrangeofresultsincludingPDS,positivity
rate,false-positiveratesandheatstability,weresimilartothosereportedinRounds1–3(3-5).TherehasbeenagradualincreaseinmedianPDSforP. falciparumatlowparasitedensitiesacrosstherounds.ThechangeinPDSforP. vivaxatlowdensitieshasbeenlessconsistentalthoughthemedianforRound4(61.8)washigherthaninthepreviousround(51.4).
ii) AnumberofRDTsdemonstratedconsistentdetectionofmalariaatlowparasitedensities(200parasites/µl),havelowfalse-positiverates,arestableattropicaltemperatures,arerelativelyeasytouse,andcandetectP. falciparum,P. vivaxinfections,orboth,addingtothenumberofavailablewell-performingtestsincludedinRounds1,2and3.
iii) Performancebetweenproductsvariedwidelyatlowparasitedensity(200parasites/µl);however,themajorityofproductsshowedahighlevelof P. falciparumand P. vivaxdetectionat2000(or5000)parasites/µl.
iv) AgainP. falciparumteststargetingHRP2antigendemon-stratedthehighestPDSforP. falciparum.Thetwoteststargetingpf-pLDHforP. falciparumdetectiondidnotpassPhase1(<80%PDSforP. falciparumat2000parasites/µl).Furthermore,ofthosetestswithbothaHRP2andpf-pLDHtestline,thePDSbasedontheHRP2linewassubstantiallybetterthanPDSbasedonthepf-pLDHline2.
1 ThisincludesfourproductsthatwerejointlistedwhichwerenotevaluatedattheCDC,refertofootnote3onthispageforproduct-specificdetails
2 AZOGMalariapf(HRPII)/pf(LDH)/(PAN-LDH)AntigenDetectionDevice(MFV-124F);SDBIOLINEMalariaAgPf/Pf/Pv(05FK100)
v) SeveralcombinationtestsachievedPDSinthehighpartoftherangeforbothP. falciparum andP. vivax.
vi) Testperformancesometimesvariedbetweenlotsofsomeproducts.
Tables3and4summarizetheperformanceofmalariaRDTsagainstP. falciparumculturedparasitesandbloodcontainingwild-typeP. falciparumandP. vivaxparasitesandPlasmodiumspp.negativesamples.Itisimportanttonotethatalthough,resultsfor48productsarereported,only44wereactuallytested.Thefourproductslistedthatwerenottestedarere-labelled/re-brandedversionsofthesameproductthatwasevaluated3.Allsixproductsaremanufacturedatthesamelocationandunderthesameconditionssothenumbersofproductsdiscussedbelowreflectthe44productsthatwereactuallytestedandthefourco-listedproductsthatarelistedwiththesameresults.Thedataarecolourcodedaccordingtoarbitrarycategories,toeasetheinterpretationofresults,andthesedonotimplylimitsofacceptableorunacceptableperformance.DetailedinformationpertainingtoproducttestingPhase1andPhase2resultsisincludedinAnnex3andAnnex4,respectively.AgraphicalrepresentationofthisdatafollowsinFigures7–15.
3 ParaCareMalariaHRP2/pLDH(Pf/Pv)COMBOandMedisensorMalariaHRP2/pLDH(Pf/PV)COMBOarerebranded/identicaltoCareStart™MalariaHRP2/pLDH(Pf/Pv)COMBO(G0161)andParaCareMalariaHRP2/pLDH(Pf/VOM)COMBOandMedisensorMalariaHRP2/pLDH(Pf/VOM)COMBOarerebranded/identicaltoCareStart™MalariaHRP2/pLDH(Pf/VOM)COMBO(G0171)
11. resUlts
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)32
Tabl
e 3:
Sum
mar
y Ph
ase
1 pe
rfor
man
ce o
f 48
mal
aria
RDT
s ag
ains
t 20
cul
ture
d P.
fal
cipa
rum
line
s at
low
(20
0) a
nd h
igh
(200
0) p
aras
ite
dens
ities
(pa
rasi
tes/
µl)
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
Pane
l Det
ectio
n Sc
orea
(n=2
0)Fa
lse-p
ositi
ve n
on-P
f in
fect
ionb
(%)
Inva
lid r
ate
(%)
(n=1
20)
200
pa
rasit
es/μ
l20
00
para
sites
/μl
200
para
sites
/μl
(n=8
0)20
00 p
aras
ites/
μl
(n=4
0)
Pf o
nly
ABON
™ M
alar
ia P
.f. R
apid
Tes
t Dev
ice
(Who
le B
lood
)IM
A-40
2AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td20
.095
.0N
AN
A0.
0BI
OCRE
DIT
Mal
aria
pf(H
RP II
)H
R010
0Ra
piG
en In
c.10
0.0
100.
0N
AN
A0.
0Fi
rstS
ign™
Mal
aria
Pf
2100
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
100.
010
0.0
NA
NA
0.0
ICT
MAL
ARIA
P.F.
ML0
4IC
T IN
TERN
ATIO
NAL
0.0
75.0
NA
NA
0.0
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN P
.f 53
5-11
IND
Diag
nost
ics
Inc.
60.0
100.
0N
AN
A0.
0M
aler
isca
n ®
Mal
aria
P.f
Antig
en T
est
MAT
-PF-
50Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
80.0
100.
0N
AN
A0.
0On
e St
ep M
alar
ia P
.F T
est (
Cass
ette
)52
2352
Blue
Cro
ss B
io-M
edic
al (B
eijin
g) C
o., L
td.
100.
010
0.0
NA
NA
0.0
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipa
rum
Mal
aria
Dev
ice
(Ver
.3)
3030
1025
Orch
id B
iom
edic
al S
yste
ms
100.
010
0.0
NA
NA
0.0
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipa
rum
Mal
aria
Dip
stic
k (V
er.3
)30
3020
25Or
chid
Bio
med
ical
Sys
tem
s 85
.010
0.0
NA
NA
0.0
Trus
ty™
Mal
aria
Ant
igen
P.f.
test
A03-
11-3
22Ar
tron
Lab
orat
orie
s In
c.80
.095
.0N
AN
A0.
0W
ondf
o On
e St
ep M
alar
ia P
.f Te
st
W 3
7-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.85
.010
0.0
NA
NA
0.0
Pf a
nd P
anAB
ON™
Plu
s M
alar
ia P
.f/Pa
n Ra
pid
Test
Dev
ice
(Who
le B
lood
)IM
A-T4
02AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td95
.010
0.0
0.0
0.0
0.0
AZOG
Mal
aria
pf (
HRP
II)/p
f (LD
H)/
(PAN
-LDH
) Ant
igen
De
tect
ion
Devi
cec
MFV
-124
FAZ
OG, I
NC.
60.0
100.
01.
30.
00.
0
Core
Mal
aria
Pan
Pf
MAL
-190
024
Core
Dia
gnos
tics
Ltd.
100.
010
0.0
0.0
0.0
0.0
EzDx
™ M
alar
ia P
an/P
f Rap
id T
est D
etec
tion
kit
RK M
AL 0
01Ad
vy C
hem
ical
(Aff
iliat
e of
Bha
rat S
erum
s &
Va
ccin
es L
td. )
85.0
100.
00.
00.
00.
0
Firs
tSig
n™ P
araV
iew
(Pan
+Pf)
2101
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
85.0
100.
00.
00.
00.
0H
umas
is M
alar
ia P
.f/Pa
n An
tigen
Tes
tAM
AL-7
025
Hum
asis,
Co.
, Ltd
.10
0.0
100.
00.
00.
00.
0IC
T M
ALAR
IA C
OMBO
ML0
2IC
T IN
TERN
ATIO
NAL
85.0
100.
00.
00.
00.
0IN
D ON
E ST
EP M
ALAR
IA A
NTI
GEN
P.f/
Pan
TEST
535-
10IN
D Di
agno
stic
s In
c.95
.010
0.0
0.0
0.0
0.0
Mal
aria
Pf/
PAN
GM
004
Gen
omix
Mol
ecul
ar D
iagn
ostic
s Pv
t.Ltd
.45
.090
.06.
32.
50.
0M
alar
ia p
f (H
RP II
)/PAN
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
1-13
-101
-1U
nite
d Bi
otec
h, In
c.
65.0
100.
00.
00.
00.
0M
aler
isca
n® M
alar
ia P
.f/PA
N (P
v, Pm
, Po)
3 L
ine
Antig
en T
est
MAT
-PF/
PAN
-50
Bhat
Bio
-Tec
h In
dia
(Pte
.) Lt
d.80
.010
0.0
0.0
0.0
0.0
MeD
iPro
Mal
aria
Ag
HRP
2/pL
DH C
ombo
IR-0
051K
Form
osa
Biom
edic
al T
echn
olog
y Co
rp.
85.0
100.
00.
00.
00.
0N
anoS
ign
Mal
aria
pf/
pan
Ag 3
.0RM
AP10
Biol
and
Ltd.
100.
010
0.0
0.0
0.0
0.0
OnSi
te P
f/Pa
n Ag
Rap
id T
est
R011
3CCT
K Bi
otec
h, In
c.65
.010
0.0
0.0
0.0
0.0
Para
HIT
- T
otal
Ver
. 1.0
(Dip
stic
k)55
IC20
3-10
Span
Dia
gnos
tics
Ltd.
75.0
100.
00.
00.
00.
0Pa
raH
IT -
Tot
al V
er. 1
.0 (D
evic
e)55
IC20
4-10
Span
Dia
gnos
tics
Ltd.
90.0
100.
00.
00.
00.
0Pa
rasc
reen
® -
Rapi
d te
st fo
r Mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
edic
als
100.
010
0.0
0.0
0 (3
9)0.
8SD
BIO
LIN
E M
alar
ia A
g Pf
/ Pan
05FK
66St
anda
rd D
iagn
ostic
s In
c.
95.0
100.
02.
5 (7
9)0
(39)
1.7
Pf a
nd P
vCa
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOG
0161
Acce
ss B
io, I
nc.
85.0
100.
00.
00.
00.
0Ca
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/VO
M) C
OMBO
G01
71Ac
cess
Bio
, Inc
.95
.010
0.0
0.0
0.0
0.0
Falc
iVax
™ -
Rap
id te
st fo
r Mal
aria
Pv/
Pf
5030
0025
Zeph
yr B
iom
edic
als
95.0
95.0
0.0
0.0
0.0
HiS
ens
Mal
aria
Ag
P.f/
P.v
Com
bo C
ard
HR3
123
HBI
Co.
, Ltd
.95
.010
0.0
0.0
0.0
0.0
HiS
ens
Mal
aria
Ag
P.f/
VOM
Com
bo C
ard
HR3
323
HBI
Co.
, Ltd
.10
0.0
100.
00.
00.
00.
0H
umas
is M
alar
ia P
.f/P.
v An
tigen
Tes
tAM
FV-7
025
Hum
asis,
Co.
, Ltd
.85
.010
0.0
0.0
2.6
(39)
0.8
Mal
aria
Pf/
PvG
M00
2G
enom
ix M
olec
ular
Dia
gnos
tics
Pvt.L
td.
45.0
100.
010
.012
.8 (3
9)0.
8
Res
ult
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 33
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
Pane
l Det
ectio
n Sc
orea
(n=2
0)Fa
lse-p
ositi
ve n
on-P
f in
fect
ionb
(%)
Inva
lid r
ate
(%)
(n=1
20)
200
pa
rasit
es/μ
l20
00
para
sites
/μl
200
para
sites
/μl
(n=8
0)20
00 p
aras
ites/
μl
(n=4
0)
Mal
aria
pf (
HRP
II) /
pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
1-13
-101
-3U
nite
d Bi
otec
h, In
c.
75.0
100.
01.
3 (7
7)0.
02.
5M
edis
enso
r Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOM
161
Med
isen
sor,
Inc.
85.0
100.
00.
00.
00.
0M
edis
enso
r Mal
aria
HRP
2/pL
DH (P
f/VO
M) C
OMBO
M17
1M
edis
enso
r, In
c.95
.010
0.0
0.0
0.0
0.0
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co.
, Ltd
.60
.095
.00.
00.
00.
0On
Site
Pf/
Pv A
g Ra
pid
Test
R011
2CCT
K Bi
otec
h, In
c.70
.010
0.0
5.0
2.5
0.0
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOG
0161
Acce
ss B
io E
thio
pia
85.0
100.
00.
00.
00.
0Pa
raCa
re M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) COM
BOG
0171
Acce
ss B
io E
thio
pia
95.0
100.
00.
00.
00.
0RA
PID
1-2-
3® H
EMA
EXPR
ESS®
MAL
ARIA
PF/
PV T
EST
MAL
-PFV
-020
7H
ema
Diag
nost
ic S
yste
ms,
LLC
0.0
0.0
1.3
(79)
2.6
(39)
1.7
RAPI
D 1-
2-3®
HEM
A CA
SSET
TE M
ALAR
IA P
F/PV
TES
TM
AL-P
FV-C
AS/2
5(10
0)H
ema
Diag
nost
ic S
yste
ms,
LLC
100.
010
0.0
0.0
0.0
0.0
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
vc05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
95.0
100.
01.
35.
00.
0Tr
usty
™ M
alar
ia A
ntig
en P
.f./p
.v. te
stA0
3-12
-322
Artr
on L
abor
ator
ies
Inc.
80.0
95.0
55.0
70.0
0.0
Pan
only
AZOG
hCG
Mal
aria
Det
ectio
n Te
st D
evic
eM
PT-1
24AZ
OG, I
NC.
55.0
100.
0N
AN
A0.
0
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
a A
sam
ple
is c
onsi
dere
d de
tect
ed o
nly
if al
l RDT
s fr
om b
oth
lots
read
by
the
first
tech
nici
an, a
t min
imum
spe
cifie
d re
adin
g tim
e, a
re p
ositi
veb
Pan
or P
v lin
e on
ly p
ositi
ve in
dica
tes
a fa
lse-
posi
tive
non
P. fa
lcip
arum
infe
ctio
nc
PDS
pres
ente
d in
the
tabl
e is
bas
ed o
n a
posi
tive
pf te
st li
ne (e
ither
pf-
HRP
2 or
pf-
pLDH
). P.
falc
ipar
um P
DS b
ased
on
indi
vidu
al te
st li
nes
for 0
5Fk1
00
(Sta
ndar
d Di
agno
stic
s In
c) w
as: p
f-pL
DH (5
% a
t 200
p/µl
; 100
% a
t 200
0p/µ
l) an
d pf
-HRP
2 (9
5% a
t 200
p/µl
; 100
% a
t 200
0p/µ
l) an
d fo
r MFV
-124
F (A
ZOG
, Inc
.)
was
pf-
pLDH
(0%
at 2
00p/
µl; 1
0% a
t 200
0p/µ
l) an
d pf
-HRP
2 (6
0% a
t 200
p/µl
; 90%
at 2
000p
/µl)
Dete
ctio
n ra
te (%
)≥9
585
-94
50-8
4<
50
Fals
e-po
sitiv
e ra
te (%
)<2
2-5
6 -1
0>1
0
Inva
lid ra
te (%
)<1
% o
f tes
ts
cond
ucte
d1-
2% o
f tes
ts
cond
ucte
d2-
5% o
f tes
ts
cond
ucte
d>5
% o
f tes
ts
cond
ucte
d
Tabl
e 3
(con
tinue
d)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)34
Tabl
e 4:
Sum
mar
y Ph
ase
2 pe
rfor
man
ce o
f 46
mal
aria
RDT
s ag
ains
t w
ild t
ype
(clin
ical
) P.
fal
cipa
rum
and
P. v
ivax
sam
ples
at
low
(20
0) a
nd h
igh
(200
0a)
para
site
den
sity
(pa
rasi
tes/
µl)
and
Plas
mod
ium
spp
. neg
ativ
e sa
mpl
es
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Pane
l Det
ectio
n Sc
oreb
False
-pos
itive
rat
es (%
)To
tal f
alse
-po
sitiv
e ra
tese
(%)
Inva
lid
rate
(%)
(n=1
192)
200
para
sites
/μl
2000
par
asite
s/μl
200
para
sites
/μl
2000
par
asite
s/μl
Clea
n-ne
gativ
e sa
mpl
es
Pf s
ampl
es
(n=9
8)Pv
sam
ples
(n
=34)
Pf s
ampl
es
(n=9
8)Pv
sam
ples
(n
=34)
Pf s
ampl
esPv
sam
ples
Pf s
ampl
esPv
sam
ples
Fals
e-po
sitiv
e no
n Pf
in
fect
ionc
(n
=392
)
Fals
e-po
sitiv
e Pf
in
fect
iond
(n
=136
)
Fals
e-po
sitiv
e no
n Pf
in
fect
ionc
(n
=196
)
Fals
e-po
sitiv
e Pf
in
fect
iond
(n
=68)
False
po
sitiv
ePl
asm
odiu
m
spp.
Infe
ctio
n (n
=232
)Pf
onl
yAB
ON™
Mal
aria
P.f.
Rap
id T
est D
evic
e (W
hole
Blo
od)
IMA-
402
ABON
Bio
phar
m (H
angz
hou)
Co.
Ltd
32.7
NA
99.0
NA
NA
0.0
NA
0.0
0.4
0.0
BIOC
REDI
T M
alar
ia p
f(HRP
II)
HR0
100
Rapi
Gen
Inc.
99.0
NA
100.
0N
AN
A97
.1N
A95
.699
.1 (2
31)
0.5
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ross
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igen
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tron
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orie
s In
c.88
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One
Step
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aria
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Test
W
37-
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uang
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Biot
ech
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td.
89.8
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99.0
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NA
0.0
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0.0
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2Pf
and
Pan
ABON
™ Pl
us M
alar
ia P.
f/Pan
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id Te
st D
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le Bl
ood)
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Bio
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m (H
angz
hou)
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Ltd
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100.
097
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00.
00.
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OG M
alar
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f (H
RPII)
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Core
Mal
aria
Pan
Pf
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Core
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30)
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rat S
erum
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5 (2
31)
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asis
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aria
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est
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umas
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o., L
td.
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94.9
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alar
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f/ P
ANG
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enom
ix M
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td.
63.3
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100.
097
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30.
70.
00.
00.
00.
0M
alar
ia p
f (H
RP II
)/PAN
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ntig
en D
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tion
Test
Dev
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nite
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otec
h, In
c.
39.8
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00.
00.
00.
1
Mal
eris
can®
Mal
aria
P.f/
PAN
(Pv,
Pm, P
o) 3
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e An
tigen
Tes
tM
AT-P
F/PA
N-5
0Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
84.7
0.0
100.
076
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0 (3
91)
2.2
0.0
1.5
1.3
0.1
MeD
iPro
Mal
aria
Ag
HRP
2/pL
DH C
ombo
IR-0
051K
Form
osa
Biom
edic
al T
echn
olog
y Co
rp.
69.4
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0.0
(391
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00.
01.
50.
90.
1N
anoS
ign
Mal
aria
pf/
pan
Ag 3
.0RM
AP10
Biol
and
Ltd.
92.9
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100.
010
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0.0
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te P
f/Pa
n Ag
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al V
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76.5
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30.
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7)0.
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reen
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r Mal
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99.0
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023
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0 (3
91)
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IOLI
NE
Mal
aria
Ag
Pf/ P
an05
FK66
Stan
dard
Dia
gnos
tics
Inc.
90
.894
.110
0.0
100.
01.
0 (3
85)
0.0
(130
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0 (1
95)
0.0
(67)
1.3
(226
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8Pf
and
Pv
Res
ult
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 35
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Pane
l Det
ectio
n Sc
oreb
False
-pos
itive
rat
es (%
)To
tal f
alse
-po
sitiv
e ra
tese
(%)
Inva
lid
rate
(%)
(n=1
192)
200
para
sites
/μl
2000
par
asite
s/μl
200
para
sites
/μl
2000
par
asite
s/μl
Clea
n-ne
gativ
e sa
mpl
es
Pf s
ampl
es
(n=9
8)Pv
sam
ples
(n
=34)
Pf s
ampl
es
(n=9
8)Pv
sam
ples
(n
=34)
Pf s
ampl
esPv
sam
ples
Pf s
ampl
esPv
sam
ples
Fals
e-po
sitiv
e no
n Pf
in
fect
ionc
(n
=392
)
Fals
e-po
sitiv
e Pf
in
fect
iond
(n
=136
)
Fals
e-po
sitiv
e no
n Pf
in
fect
ionc
(n
=196
)
Fals
e-po
sitiv
e Pf
in
fect
iond
(n
=68)
False
po
sitiv
ePl
asm
odiu
m
spp.
Infe
ctio
n (n
=232
)Ca
reSt
art™
Mal
aria
HR
P2/p
LDH
(Pf
/Pv)
CO
MBO
G01
61Ac
cess
Bio
, Inc
.90
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0.0
100.
00.
30.
01.
01.
50.
00.
0Ca
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/VO
M) C
OMBO
G01
71Ac
cess
Bio
, Inc
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0.0
100.
00.
30.
70.
52.
90.
00.
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lciV
ax™
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apid
test
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alar
ia P
v/Pf
50
3000
25Ze
phyr
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med
ical
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100.
00.
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90.
02.
97.
30.
0H
iSen
s M
alar
ia A
g P.
f/P.
v Co
mbo
Car
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R312
3H
BI C
o., L
td.
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79.4
100.
094
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3 (3
91)
0.0
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0.0
0.4
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ens
Mal
aria
Ag
P.f/
VOM
Com
bo C
ard
HR3
323
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Co.
, Ltd
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0.0
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0.0
0.0
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0.0
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0.0
Hum
asis
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aria
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P.v
Antig
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est
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umas
is, C
o., L
td.
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100.
010
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100.
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50.
70.
51.
51.
30.
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alar
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omix
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ecul
ar D
iagn
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s Pv
t.Ltd
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094
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90.
80.
70.
50.
00.
90.
0M
alar
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f (HR
P II)
/ pv
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H) A
ntig
en D
etec
tion
Test
Dev
ice1-
13-1
01-3
Uni
ted
Biot
ech,
Inc.
60
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092
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50.
0 (1
35)
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(195
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50.
0 (2
30)
0.5
Med
isen
sor M
alar
ia H
RP2/
pLDH
(Pf/
Pv) C
OMBO
M16
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edis
enso
r, In
c.90
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0.0
100.
00.
30.
01.
01.
50.
00.
0M
edis
enso
r Mal
aria
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2/pL
DH (P
f/VO
M) C
OMBO
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edis
enso
r, In
c.89
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0.0
100.
00.
30.
70.
52.
90.
00.
0On
e St
ep M
alar
ia P
.F/P
.V T
est (
Cass
ette
)52
3352
Blue
Cro
ss B
io-M
edic
al (B
eijin
g) C
o., L
td.
50.0
0.0
95.9
91.2
0.0
2.9
0.0
1.5
1.3
0.0
OnSi
te P
f/Pv
Ag
Rapi
d Te
stR0
112C
CTK
Biot
ech,
Inc.
79.6
100.
010
0.0
100.
01.
50.
02.
00.
01.
30.
0Pa
raCa
re M
alar
ia H
RP2/
pLDH
(Pf/
Pv) C
OMBO
G01
61Ac
cess
Bio
Eth
iopi
a90
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0.0
100.
00.
30.
01.
01.
50.
00.
0Pa
raCa
re M
alar
ia H
RP2/
pLDH
(Pf/
VOM
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BOG
0171
Acce
ss B
io E
thio
pia
89.8
91.2
100.
010
0.0
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0.7
0.5
2.9
0.0
0.0
RAPI
D 1-
2-3®
HEM
A CA
SSET
TE M
ALAR
IA P
F/PV
TES
TM
AL-P
FV-
CAS/
25(1
00)
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a Di
agno
stic
Sys
tem
s, LL
C92
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0.0
100.
00.
00.
70.
01.
54.
30.
0
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
vf05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
96.9
97.1
100.
010
0.0
0.3
0.0
0.5
0.0
2.2
0.0
Trus
ty™
Mal
aria
Ant
igen
P.f.
/p.v.
test
A03-
12-3
22Ar
tron
Lab
orat
orie
s In
c.88
.838
.299
.010
0.0
13.3
27.4
(135
)16
.0 (1
94)
19.4
(67)
32.0
(231
)0.
5Pa
n on
lyAZ
OG h
CG M
alar
ia D
etec
tion
Test
Dev
ice
MPT
-124
AZOG
, IN
C.61
.20.
099
.055
.9N
AN
AN
AN
A2.
20.
2
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
a 5
(5%
) of t
he 9
8 P.
falc
ipar
um d
ilutio
n sa
mpl
es s
ets
wer
e 20
0 an
d 50
00 p
aras
ites/
µl a
nd 1
(3%
) of t
he 3
4 P.
viv
ax d
ilutio
n sa
mpl
e se
ts w
ere
200
and
5000
par
asite
s/µl
b A
sam
ple
is c
onsi
dere
d de
tect
ed o
nly
if al
l RDT
s fr
om b
oth
lots
read
by
the
first
tech
nici
an, a
t min
imum
spe
cifie
d re
adin
g tim
e, a
re p
ositi
vec
For c
ombi
natio
n te
sts,
Pan
or P
v lin
e, o
nly,
posi
tive
indi
cate
s a
fals
e-po
sitiv
e no
n P.
falc
ipar
um in
fect
ion
d Pf
line
pos
itive
indi
cate
s a
fals
e-po
sitiv
e P.
falc
ipar
um in
fect
ion
e Th
e to
tal n
umbe
r of t
imes
a p
ositi
ve re
sult
for m
alar
ia w
as g
ener
ated
whe
n it
shou
ld n
ot h
ave
been
f
PDS
pres
ente
d in
the
tabl
e is
bas
ed o
n a
posi
tive
pf te
st li
ne (e
ither
pf-
HRP
2 or
pf-
pLDH
). P.
falc
ipar
um P
DS b
ased
on
indi
vidu
al te
st li
nes
for 0
5Fk1
00 (S
tand
ard
Diag
nost
ics
Inc)
was
: pf-
pLDH
(25.
5% a
t 200
p/µl
; 96.
9% a
t 200
0p/µ
l) an
d pf
-HRP
2 (9
6.9%
at 2
00p/
µl; 1
00%
at 2
000p
/µl)
and
for M
FV-1
24F
(AZO
G, I
nc.)
was
pf-
pLDH
(3.1
% a
t 200
p/µl
; 37.
8% a
t 200
0p/µ
l) an
d pf
-HRP
2 (6
2.2%
at 2
00p/
µl; 9
8% a
t 200
0p/µ
l)
Dete
ctio
n ra
te (%
)≥9
585
-94
50-8
4<
50
Fals
e-po
sitiv
e ra
te (%
)<2
2-5
6 -1
0>1
0
Inva
lid ra
te (%
)<1
% o
f tes
ts
cond
ucte
d1-
2% o
f tes
ts
cond
ucte
d2-
5% o
f tes
ts
cond
ucte
d>5
% o
f tes
ts
cond
ucte
d
Tabl
e 4
(con
tinue
d)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)36
11.2. phase 1 - p. falciparum culture panelThemajorityoftests(94%)consistentlydetected≥95%ofP. falciparumculturedparasitesathighparasitedensities(2000(or5000)parasites/µl);however,thepaneldetectionscorewashighlyvariable(0-100%)atlowparasitedensities(200parasites/µl).Atlowparasitedensities,theproductswiththehighestPDStargetedHRP2(Figure7).TwoproductshadaPDS<80%onhighparasitedensitysamplesandtherefore,didnotproceedontoPhase2.
Figure 7: Phase 1 P. falciparum panel detection score of malaria RDTs at low (200) and high (2000) parasite densities (parasites/µl) according to target antigen type (HRP2 or pLDH)
a A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive; b Refer to Table 3 for individual HRP2 and pf-pLDH test line PDS.
Res
ult
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 37
11.3. phase 2 - Wild-type p. falciparum and p. vivax and plasmodium spp. negative samples 11.3.1. p. falciparum detectionAll48productsinRound4weredesignedtodetectP. falci-parum.ComparedtotheP. falciparumculturedparasitepanel,P. falciparumPDSandpositivityratesofwild-typesamples
weregenerallyhigher,reflectingtheincreasedantigencontentofwild-typesamples.AsinPhase1,themajorityoftests(45;98%)hadapaneldetectionscore≥95%ofP. falciparumsamplesathighparasitedensities.SevenofthetenproductsspecificforP. falciparumaloneachievedPDSof≥75%againstlowparasitedensitysamples(Figure8).
Figure 8: Phase 2 P. falciparum panel detection score of malaria RDTs at low (200) and high (2000a) parasite density (parasites/µl) according to target antigen type (HRP2 or pLDH)b
a 5 (5%) of the 98 P. falciparum dilution samples sets were 200 and 5000 parasites/µl and 1 (3%) of the 34 P. vivax dilution sample sets were 200 and 5000 parasites/µl
b Phase 2 evaluation panel consisted of 98 clinical blood samples containing wild type P. falciparum. RDTs performed = 2 tests x 2 lots at 200 p/µl and 1 test x 2 lots at 2000 p/µl;
c A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive; d Refer to Table 4 for individual HRP2 and pf-pLDH test line PDS
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)38
11.3.2. p. vivax detection Figure9illustrates,that28(78%)ofproductsdesignedtodetectP. vivaxdetected≥75%ofthehighparasitedensities(2000(or5000)parasites/µl)consistently,and17(47%)achievedthesamethresholdofPDSagainst200parasite/µLsamples.Theoveralldetectionofthelowparasitedensitywild-typeP. vivaxsampleswaslowerthanthatforP. falciparum.Atlowparasitedensities(200parasite/µL),only11productshadpaneldetectionscores≥90%and19productshadaPDSof<75%.(Table4)
11.3.3. combined detection of p. falciparum and p. vivax Consideringthe36pan-specificandcombinationtests,17(47%)hadaPDSof≥75%forbothP. falciparumandP. vivaxatthelowparasitedensity(200parasites/µl)(Table4).Severalperformedwellathighparasitedensities.Thesinglepan-specificonlytesthada0%PDSforP. vivaxatthelowparasitedensities.
Figure 9: Phase 2 P. vivax panel detection score of malaria RDTs at low (200) and high (2000a) parasite densities (parasites/µl) according to target antigen type (aldolase, pLDH)b
2000 (pLDH)
200 (pLDH)
2000 (aldolase)
200 (aldolase)
a 1 (3%) of the 34 P. vivax dilution sample sets were 200 and 5000 parasites/µl; b Phase 2 evaluation panel consisted of 34 clinical blood samples containing wild type P. vivax; RDTs performed = 2 tests x 2 lots at 200 p/µl
and 1 test x 2 lots at 2000 p/µl;c A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive
Res
ult
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 39
11.3.4. p. falciparum and p. vivax positivity rate InadditiontothePDS,thepositivityratewasalsomeasured.ThisputsasidetestandlotdifferencescapturedinthePDSandmeasuresthetotalnumberoftimesatestreturnedapositiveresult.Asexpected,positivityrateswerehigherthanPDSbutmirroredPDSagainstwild-typeP. falciparumandP. vivaxsamples(Figures10and11).
Figure 10: Phase 2 P. falciparum panel detection score PDS and positivity rate at 200 parasites/µla
positivity rate (HRP2)
panel detection score (HRP2)
a Phase 2 evaluation panel consisted of 98 clinical blood samples containing wild type P. falciparum. RDTs performed = 2 tests x 2 lots at 200 p/µl and 1 test x 2 lots at 2000 p/µl;
b A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive; c The total number of times a test returned a positive result; d Refer to Table 4 for individual PDS based on HRP2 and pf-pLDH test lines; for positivity rate (PR) at 200 p/µl: 05Fk100 (Standard Diagnostics Inc)
was: pf-pLDH=45.2% and pf-HRP2=99% and for MFV-124F (AZOG, Inc.) PR at 200 p/µl was pf-pLDH=9.2% and pf-HRP2 75.5%
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)40
11.3.5. band intensity AlthoughRDTsarenotquantitative,techniciansdidgradepositiveresultsaccordingtoastandardcolourchartandmeanbandintensity(forpositiveresults)wascalculated(Annex4-TablesA4.2,A4.3).Therewasapositivecorrelationbetweenpaneldetectionscoreandbandintensity(Spearmanrankcorrelation,r=0.83,P<0.001).
11.3.6. false-positive rates Overallfalse-positiverateswerelow,withonlyfivetestshavingrates>10%onclean-negativesamples,onanytestline(Figures12,13).Thesesamefivetestsalsohadhighfalse-positive(FP)rateswithsamplescontainingotherpathogensandimmunologicalabnormalities.Afewtestswithlowfalse-positiveratesonclean-negativesamplesreturnedfalse-positiverates(range8.3%–50%)againstsamplesfrom
Figure 11: Phase 2 P. vivax panel detection score and positivity rate at 200 parasites/µla
positivity rate (pLDH)
panel detection score (pLDH)
positivity rate (aldolase)
panel detection score (aldolase)
a Phase 2 evaluation panel consisted of 34 clinical blood samples containing wild type P. vivax; . RDTs performed = 2 tests x 2 lots at 200 p/µl and 1 test x 2 lots at 2000 p/µl;
b A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive; c The total number of times a test returned a positive result
Res
ult
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 41
patientswithotherbloodpathogens,particularlyfordengueandleishmaniasisandforimmunologicalbloodabnormalities(FPraterange3.9%–66.7%),includingRPR,rheumatoidfactor,anti-DNAantibodyandhumananti-mouseantibodysamples.However,samplesizesweresmall.Fordetailedinformationregardingthebloodabnormalityorpathogenthatgeneratedfalse-positiveresultsforaspecificproductrefertoAnnex4(TablesA4.8,A4.9).
Importantly,therewasnocleartrendofhigherfalse-positiveratesfortestswithhigherPDS,indicatingthattherewasnotacleartrade-offbetweensensitivityandspecificityoftestsatthesedetectionthresholds(Figures14,15).
Figure 12: Phase 2 P. falciparum (P. falciparum test line) false-positive rate against clean-negative samplesa
a Phase 2 evaluation panel included 100 Plasmodium spp. negative samples of which 58 were clean-negatives from healthy volunteers with no known current illness or blood abnormality
b Individual false-positive (FP) rates based on HRP2 and pf-pLDH test lines were: 05Fk100 (Standard Diagnostics Inc): pf-pLDH=0% and pf-HRP2=2.2% and for MFV-124F (AZOG, Inc.) FP was pf-pLDH=1.3% and pf-HRP2=0.4 %
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)42
Figure 13: Phase 2 Plasmodium spp. (pan or P. vivax/Pvom test line) false-positive rate against clean-negative samplesa
a Phase 2 evaluation panel included 100 Plasmodium spp. negative samples of which 58 were clean-negatives, from healthy volunteers with no known current illness or blood abnormality
Res
ult
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 43
Figure 14: Phase 2 P. falciparum false-positive ratea versus P. falciparum panel detection scoreb at low (200) parasite density (parasites/µl)
Fal
se-p
osi
tive
rate
(%)
P. falciparum PDS at 200 parasites/µla False-positive rate is on clean-negatives, only; b A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive.
Figure 15: Phase 2 P. vivax false-positive ratea versus P. vivax panel detection scoreb at low (200) parasite density (parasites/µl)
Fal
se-p
osi
tive
rate
(%)
P. vivax PDS at 200 parasites/µla False-positive rate is on clean-negatives, only; b A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive.
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)44
12. Heat stabilitY
AsingleP. falciparumculturesample(fromthesamelotasRound3)wasusedasthereferencesampleforheatstabilitytesting.Variationsinbaselineperformancereflectinter-testvariationsincethesampleat200parasites/µlwasatthelimitofdetectionofsomeproducts.
Severalproductswerestable,meaningthattheydetectedaP. falciparumculturedsamplethesamenumberoftimesatbaselineandfollowingincubationfortwomonths(75%humidity)at4°C,35°Cand45°C.(Table5).DetailedresultsarepresentedinAnnex4(TablesA4.11-A4.13a)andinFigures16-23,showingtheresultsofbothlotsarecombined(maximumscore30;15testsperlotagainst200parasites/µl;maximumscore10;5testsperlotagainst2000parasites/µl).
Overall,productsshowedgreaterstabilityagainstsampleswithhigh(2000parasites/µl)comparedtolow(200parasites/µl)parasitedensities,Figures16,18,20,22andFigures17,19,21,23,respectively,assmalldeteriorationsatthesehighparasitedensitieswillnotbeapparent.Inseveralcasesproductswhichhadbaselinepositivitylessthan100%basedonthepan-lineshowedunpredictablevariationinpositivityratesonsubsequenttestingaftertwomonths,consistentwithtestlinesontheborderlineofvisibility(i.e.asthe200
parasite/µLculturesampleusedisnearthethresholdofdetectionofmanyproducts,aminorchangeindetectionthresholdmaycausealargeapparentchangeintherecordedresult).Sometestlinesshowedahighdegreeofstabilityat35°Cbutlosttheabilitytodetectantigenafterincubationat45°C.Aspreviouslyreported,afewproductsshowedanimprovedperformancewithincubation(Figures17,18,20,22,23).Overall,thestabilityofpan-pLDH-detectingtestlineswasmuchlowerthanthatforHRP2-detectingtestlines,forbothhighandlowparasitedensitysamples.Theonlytwoproductswithgoodreactivityafterprolongedstorageat35°Cand45°Chadveryhighfalse-positiveratesforwild-typeandparasite-negativesampletypes.
Thesummaryresultsofheat/thermalstabilitytestingarepresentedinTable5.Notethat,asaculture-derivedP. falci-parum sampleisusedforheatstabilitytesting,itisnotpossibletoprovidestabilitydataontestlinesthatdetectonlynon-P. falciparumparasites.Suchdata,andconfirmatorydataonthestabilityofrecentproductionlotsofalltests,shouldbeobtainedfrommanufacturersduringproductselectionprocesseswhenprocuringRDTs(Annex5a).
Res
ult
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 45
Tabl
e 5:
Hea
t st
abili
ty t
estin
g re
sult
s fo
r 46
mal
aria
RDT
s on
a c
ultu
red
P. f
alci
paru
m s
ampl
e at
low
(20
0) a
nd h
igh
(200
0) p
aras
ite
dens
ity
(par
asit
es/µ
l). P
ositi
vity
rat
e at
bas
elin
e, a
nd a
fter
60
days
in
cuba
tion
at 3
5°C
and
45°C
c
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Posit
ive
test
res
ults
for
P.
fal
cipa
rum
(Pf
line)
Posit
ive
test
res
ults
for
P.
fal
cipa
rum
(Pan
line
)Po
sitiv
e te
st r
esul
ts f
or
P. f
alci
paru
m (P
f lin
e)Po
sitiv
e te
st r
esul
ts f
or
P. f
alci
paru
m (P
an li
ne)
200
para
sites
/μl
200
para
sites
/μl
2000
par
asite
s/μl
2000
par
asite
s/μl
Base
line
35°C
45°C
Base
line
35°C
45°C
Base
line
35°C
45°C
Base
line
35°C
45°C
Num
ber
of t
ests
pos
itive
(
max
. 30)
Num
ber
of t
ests
pos
itive
(m
ax. 3
0)N
umbe
r of
tes
ts p
ositi
ve
(max
. 10)
Num
ber
of t
ests
pos
itive
(m
ax. 1
0)Lo
ts 1
and
2 c
ombi
ned
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
ned
Lots
1 a
nd 2
com
bine
dPf
onl
yAB
ON™
Mal
aria
P.f.
Rap
id T
est D
evic
e (W
hole
Blo
od)
IMA-
402
ABON
Bio
phar
m (H
angz
hou)
Co.
Ltd
15.0
15.0
17.0
NA
NA
NA
10.0
10.0
10.0
NA
NA
NA
BIOC
REDI
T M
alar
ia p
f(HRP
II)
HR0
100
Rapi
Gen
Inc.
30.0
30.0
30.0
NA
NA
NA
10.0
10.0
10.0
NA
NA
NA
Firs
tSig
n™ M
alar
ia P
f21
00CB
-25
Uni
med
Inte
rnat
iona
l Inc
.30
.030
.030
.0N
AN
AN
A10
.010
.010
.0N
AN
AN
A
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN P
.f 53
5-11
IND
Diag
nost
ics
Inc.
30.0
30.0
26.0
NA
NA
NA
10.0
10.0
10.0
NA
NA
NA
Mal
eris
can
® M
alar
ia P
.f An
tigen
Tes
tM
AT-P
F-50
Bhat
Bio
-Tec
h In
dia
(Pte
.) Lt
d.30
.030
.030
.0N
AN
AN
A10
.010
.010
.0N
AN
AN
A
One
Step
Mal
aria
P.F
Tes
t (Ca
sset
te)
5223
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co.
, Ltd
.30
.030
.030
.0N
AN
AN
A10
.010
.010
.0N
AN
AN
A
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipa
rum
Mal
aria
De
vice
(Ver
.3)
3030
1025
Orch
id B
iom
edic
al S
yste
ms
30.0
30.0
30.0
NA
NA
NA
10.0
10.0
10.0
NA
NA
NA
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipa
rum
Mal
aria
Di
pstic
k (V
er.3
)30
3020
25Or
chid
Bio
med
ical
Sys
tem
s 30
.029
.030
.0N
AN
AN
A10
.010
.010
.0N
AN
AN
A
Trus
ty™
Mal
aria
Ant
igen
P.f.
test
A03-
11-3
22Ar
tron
Lab
orat
orie
s In
c.30
.030
.017
.0N
AN
AN
A10
.010
.010
.0N
AN
AN
A
Won
dfo
One
Step
Mal
aria
P.f
Test
W
37-
CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
30.0
29.0
30.0
NA
NA
NA
10.0
10.0
10.0
NA
NA
NA
Pf a
nd P
anAB
ON™
Plus
Mal
aria
P.f/P
an R
apid
Test
Dev
ice (W
hole
Bloo
d)IM
A-T4
02AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td30
.030
.030
.00.
00.
00.
010
.010
.010
.00.
00.
00.
0
AZOG
Mal
aria
pf (
HRP
II)/p
f (LD
H)/
(PAN
-LDH
) Ant
igen
De
tect
ion
Devi
cea
MFV
-124
FAZ
OG, I
NC.
29.0
29.0
30.0
1.0
0.0
0.0
10.0
10.0
10.0
2.0
0.0
0.0
AZOG
Mal
aria
pf (
HRP
II)/p
f (LD
H)/
(PAN
-LDH
) Ant
igen
De
tect
ion
Devi
ceb
MFV
-124
FAZ
OG, I
NC.
4.0
1.0
2.0
1.0
0.0
0.0
5.0
1.0
5.0
2.0
0.0
0.0
Core
Mal
aria
Pan
Pf
MAL
-190
024
Core
Dia
gnos
tics
Ltd.
30.0
30.0
30.0
8.0
24.0
25.0
10.0
10.0
10.0
10.0
10.0
10.0
EzDx
™ M
alar
ia P
an/P
f Rap
id T
est D
etec
tion
kit
RK M
AL 0
01Ad
vy C
hem
ical
(Aff
iliat
e of
Bha
rat
Seru
ms
& V
acci
nes
Ltd.
)30
.030
.030
.00.
00.
00.
010
.010
.010
.010
.010
.07.
0
Firs
tSig
n™ P
araV
iew
(Pan
+Pf)
2101
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
29.0
30.0
30.0
0.0
0.0
4.0
10.0
10.0
10.0
10.0
10.0
10.0
Hum
asis
Mal
aria
P.f/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is, C
o., L
td.
30.0
30.0
30.0
23.0
30.0
30.0
10.0
10.0
10.0
10.0
10.0
10.0
ICT
MAL
ARIA
COM
BOM
L02
ICT
INTE
RNAT
ION
AL29
.029
.028
.01.
06.
04.
010
.010
.010
.010
.05.
07.
0
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN P
.f/Pa
n TE
ST53
5-10
IND
Diag
nost
ics
Inc.
30.0
30.0
30.0
6.0
1.0
10.0
10.0
10.0
10.0
10.0
10.0
10.0
Mal
aria
Pf/
PAN
GM
004
Gen
omix
Mol
ecul
ar D
iagn
ostic
s Pvt
.Ltd.
17.0
7.0
8.0
0.0
0.0
0.0
10.0
10.0
10.0
6.0
9.0
5.0
Mal
aria
pf (
HRP
II)/P
AN (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e1-
13-1
01-1
Uni
ted
Biot
ech,
Inc.
30
.029
.029
.05.
00.
00.
010
.010
.010
.09.
04.
05.
0
Mal
eris
can®
Mal
aria
P.f/
PAN
(Pv,
Pm, P
o) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PAN
-50
Bhat
Bio
-Tec
h In
dia
(Pte
.) Lt
d.30
.030
.030
.00.
00.
00.
010
.010
.010
.00.
00.
00.
0
MeD
iPro
Mal
aria
Ag
HRP
2/pL
DH C
ombo
IR-0
051K
Form
osa
Biom
edic
al T
echn
olog
y Co
rp.
30.0
29.0
29.0
0.0
0.0
0.0
10.0
10.0
10.0
0.0
0.0
0.0
Nan
oSig
n M
alar
ia p
f/pa
n Ag
3.0
RMAP
10Bi
olan
d Lt
d.30
.030
.030
.00.
00.
00.
010
.010
.010
.010
.010
.010
.0
OnSi
te P
f/Pa
n Ag
Rap
id T
est
R011
3CCT
K Bi
otec
h, In
c.30
.030
.028
.00.
01.
00.
010
.010
.010
.07.
02.
01.
0
Para
HIT
- T
otal
Ver
. 1.0
(Dip
stic
k)55
IC20
3-10
Span
Dia
gnos
tics
Ltd.
30.0
28.0
14.0
15.0
0.0
0.0
10.0
10.0
6.0
10.0
9.0
0.0
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)46
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Posit
ive
test
res
ults
for
P.
fal
cipa
rum
(Pf
line)
Posit
ive
test
res
ults
for
P.
fal
cipa
rum
(Pan
line
)Po
sitiv
e te
st r
esul
ts f
or
P. f
alci
paru
m (P
f lin
e)Po
sitiv
e te
st r
esul
ts f
or
P. f
alci
paru
m (P
an li
ne)
200
para
sites
/μl
200
para
sites
/μl
2000
par
asite
s/μl
2000
par
asite
s/μl
Base
line
35°C
45°C
Base
line
35°C
45°C
Base
line
35°C
45°C
Base
line
35°C
45°C
Num
ber
of t
ests
pos
itive
(
max
. 30)
Num
ber
of t
ests
pos
itive
(m
ax. 3
0)N
umbe
r of
tes
ts p
ositi
ve
(max
. 10)
Num
ber
of t
ests
pos
itive
(m
ax. 1
0)Lo
ts 1
and
2 c
ombi
ned
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
ned
Lots
1 a
nd 2
com
bine
dPa
raH
IT -
Tot
al V
er. 1
.0 (D
evic
e)55
IC20
4-10
Span
Dia
gnos
tics
Ltd.
30.0
30.0
30.0
0.0
0.0
0.0
10.0
10.0
10.0
10.0
10.0
10.0
Para
scre
en®
- Ra
pid
test
for M
alar
ia P
an/P
f50
3100
25Ze
phyr
Bio
med
ical
s30
.030
.030
.026
.04.
025
.010
.010
.010
.010
.010
.010
.0
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
an05
FK66
Stan
dard
Dia
gnos
tics
Inc.
29
.029
.030
.05.
03.
00.
09.
010
.010
.09.
010
.010
.0
Pf a
nd P
vCa
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOG
0161
Acce
ss B
io, I
nc.
30.0
30.0
30.0
NA
NA
NA
10.0
10.0
10.0
NA
NA
NA
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) COM
BOG
0171
Acce
ss B
io, I
nc.
30.0
30.0
30.0
NA
NA
NA
10.0
10.0
10.0
NA
NA
NA
Falc
iVax
™ -
Rap
id te
st fo
r Mal
aria
Pv/
Pf
5030
0025
Zeph
yr B
iom
edic
als
30.0
30.0
30.0
NA
NA
NA
10.0
10.0
10.0
NA
NA
NA
HiS
ens
Mal
aria
Ag
P.f/
P.v
Com
bo C
ard
HR3
123
HBI
Co.
, Ltd
.30
.030
.030
.0N
AN
AN
A10
.010
.010
.0N
AN
AN
A
HiS
ens
Mal
aria
Ag
P.f/
VOM
Com
bo C
ard
HR3
323
HBI
Co.
, Ltd
.30
.030
.030
.0N
AN
AN
A10
.010
.010
.0N
AN
AN
A
Hum
asis
Mal
aria
P.f/
P.v
Antig
en T
est
AMFV
-702
5H
umas
is, C
o., L
td.
30.0
30.0
30.0
NA
NA
NA
10.0
10.0
10.0
NA
NA
NA
Mal
aria
Pf/
PvG
M00
2G
enom
ix M
olec
ular
Dia
gnos
tics P
vt.Lt
d.12
.010
.012
.0N
AN
AN
A10
.010
.010
.0N
AN
AN
A
Mal
aria
pf (
HRP
II) /
pv (p
LDH)
Ant
igen
Det
ectio
n Te
st D
evice
1-13
-101
-3U
nite
d Bi
otec
h, In
c.
30.0
30.0
30.0
NA
NA
NA
9.0
10.0
10.0
NA
NA
NA
Med
isen
sor M
alar
ia H
RP2/
pLDH
(Pf/
Pv) C
OMBO
M16
1M
edis
enso
r, In
c.30
.030
.030
.0N
AN
AN
A10
.010
.010
.0N
AN
AN
A
Med
isen
sor M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) COM
BOM
171
Med
isen
sor,
Inc.
30.0
30.0
30.0
NA
NA
NA
10.0
10.0
10.0
NA
NA
NA
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co.
, Ltd
.12
.02.
00.
0N
AN
AN
A10
.010
.09.
0N
AN
AN
A
OnSi
te P
f/Pv
Ag
Rapi
d Te
stR0
112C
CTK
Biot
ech,
Inc.
30.0
30.0
27.0
NA
NA
NA
10.0
10.0
10.0
NA
NA
NA
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOG
0161
Acce
ss B
io E
thio
pia
30.0
30.0
30.0
NA
NA
NA
10.0
10.0
10.0
NA
NA
NA
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/VO
M) C
OMBO
G01
71Ac
cess
Bio
Eth
iopi
a30
.030
.030
.0N
AN
AN
A10
.010
.010
.0N
AN
AN
A
RAPI
D 1-
2-3®
HEM
A CA
SSET
TE M
ALAR
IA P
F/PV
TES
TM
AL-P
FV-
CAS/
25(1
00)
Hem
a Di
agno
stic
Sys
tem
s, LL
C30
.030
.030
.0N
AN
AN
A10
.010
.010
.0N
AN
AN
A
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
va05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
30.0
30.0
29.0
NA
NA
NA
10.0
10.0
10.0
NA
NA
NA
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
vb05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
8.0
1.0
1.0
NA
NA
NA
10.0
10.0
10.0
NA
NA
NA
Trus
ty™
Mal
aria
Ant
igen
P.f.
/p.v.
test
A03-
12-3
22Ar
tron
Lab
orat
orie
s In
c.30
.030
.011
.0N
AN
AN
A10
.010
.010
.0N
AN
AN
A
Pan
only
AZOG
hCG
Mal
aria
Det
ectio
n Te
st D
evic
eM
PT-1
24AZ
OG, I
NC.
NA
NA
NA
30.0
30.0
30.0
NA
NA
NA
10.0
10.0
10.0
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
a Re
sults
pre
sent
ed i
n th
e ta
ble
are
base
d on
sta
bilit
y of
a p
f-H
RP2
line
b Re
sults
pre
sent
ed i
n th
e ta
ble
are
base
d on
sta
bilit
y of
a p
f-pL
DH li
nec
Posi
tive
resu
lts p
rese
nted
in th
e ta
ble
are
base
d on
sta
bilit
y of
a p
ositi
ve re
ader
1 o
r rea
der 2
resu
lt
Tabl
e 5
(con
tinue
d)
Res
ult
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 47
12.1. p. falciparum test lines
Figure 16: Heat stability of P. falciparum specific test line of P. falciparum only tests against a low density P. falciparum sample (200 parasites/µl). Positivity rate at baseline, and after 60 days incubation.
0
20
30
10
Baseline 35 °C 45 °C
No
. of
po
sitiv
e re
sults
fro
m t
wo
lots
a
a Maximum score is 30 (15 tests x 2 lots)
Figure 17: Heat stability of P. falciparum specific test line of P. falciparum tests against a high density P. falciparum sample (2000 parasites/µl). Positivity rate at baseline, and after 60 days incubation.
0
8
10
6
4
2
Baseline 35 °C 45 °C
No
. of
po
sitiv
e re
sults
fro
m t
wo
lots
a
a Maximum score is 10 (5 tests x 2 lots);
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)48
Figure 18: Heat stability of P. falciparum specific test line in combination tests against a low density P. falciparum sample (200 parasites/µl). Positivity rate at baseline, and after 60 days incubation.
No
. of
po
sitiv
e re
sults
fro
m t
wo
lots
a
0
10
20
30
Baseline 35 °C 45 °C
a Maximum score is 30 (15 tests x 2 lots)b Refer to Table A4.11 for individual HRP2 and pf-pLDH test line performance
Res
ult
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 49
12.2. pan-specific test lines
Figure 19: Heat stability of P. falciparum specific test line in combination tests against a high density P. falciparum sample (2000 parasites/µl). Positivity rate at baseline, and after 60 days incubation.
No
. of
po
sitiv
e re
sults
fro
m t
wo
lots
a
Baseline 35 °C 45 °C0
8
10
6
4
2
a Maximum score is 10 (5 tests x 2 lots)b Refer to Table A4.12 for individual HRP2 and pf-pLDH test line performance
Figure 20: Heat stability of pan-line of pan-specific tests against a low density P. falciparum sample (200 parasites/µl). Positivity rate at baseline, and after 60 days incubation.
No
. of
po
sitiv
e re
sults
fro
m t
wo
lots
a
Baseline 35 °C 45 °C0
30
20
10
a Maximum score is 30 (15 tests x 2 lots)b Single test line includes pf-pLDH, pan-pLDH and HRP2 antibodies
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)50
Figure 23: Heat stability of pan-line of combination tests against a high density P. falciparum sample (2000 parasites/µl). Positivity rate at baseline, and after 60 days incubation.
No
. of
po
sitiv
e re
sults
fro
m t
wo
lots
a
Baseline 35 °C 45 °C0
10
8
6
4
2
a Maximum score is 10 (5 tests x 2 lots)
Figure 22: Heat stability of pan-line of combination tests against a low density P. falciparum sample (200 parasites/µl). Positivity rate at baseline, and after 60 days incubation.
No
. of
po
sitiv
e re
sults
fro
m t
wo
lots
a
0
20
30
10
Baseline 35 °C 45 °C
a Maximum score is 30 (15 tests x 2 lots)
Figure 21: Heat stability of pan-line of pan-specific tests against a high density P. falciparum sample (2000 parasites/µl). Positivity rate at baseline, and after 60 days incubation.
No
. of
po
sitiv
e re
sults
fro
m t
wo
lots
a
Baseline 35 °C 45 °C0
10
8
6
4
2
a Maximum score is 10 (5 tests x 2 lots)b Single test line includes pf-pLDH, pan-pLDH and HRP2 antibodies
Res
ult
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 51
13. ease-of-Use description
Afterbecomingproficientatusingaproduct,twotechniciansjointlyproducedanagreedassessmentofproductusability.Theresults,whichconstituteadescriptionoftheproductwithemphasisonaspectsconsideredofimportancetoease-of-useinafieldsetting,arepresentedinTable6.Importantly,theassessmentdoesnotcomparebloodtransferdeviceswhicharecriticaltobothsafetyandaccuracyofthetestingprocedure,andposeasignificantchallengetomanyusers.Thesecanbevariedbymanufacturerswithmanyproducts.Procurementdecisionsshouldconsiderwhichtransferdevicesarebestsuitedtotheintendedusersanddiscussthiswiththemanufacturepriortoprocurement.Ultimately,itisstronglyrecommendedthatRDTpackaging,contents,safetyandease-of-usebeassessedinthefieldaspartoftheproductselectionprocess(TableA5.1).Furthermore,end-usersshouldbeawareofmajorRDTanomaliesthatmaybeencounteredinsomeproductionlots(FigureA5.2).
Res
ult
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)52 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 53
Tabl
e 6:
Eas
e-of
-use
des
crip
tion
of 4
8 m
alar
ia R
DTs
incl
uded
in R
ound
4: W
HO
Mal
aria
RDT
Pro
duct
Tes
ting
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
Bloo
d sa
fety
aIn
stru
ctio
n qu
ality
bCo
m-
bine
d sc
ore
(max
. 5)
Num
ber
of t
imed
st
eps
Tota
l tim
e to
re
sult
Bloo
d tr
ansf
er
devi
ce
Form
atLa
ngua
ge
of
inst
ruct
ion
Item
s in
clud
ed in
pac
kage
cM
ixin
g we
lls
invo
lved
Retra
ct-
able
ne
edle
St
rip
Expo
sed
Scor
e (m
ax. 3
) No
di
agra
mDi
agra
m
of re
sult
Diag
ram
of
resu
lt
& m
etho
dSc
ore
(max
. 2)
Pf o
nly
ABON
™ M
alar
ia P
.f. R
apid
Tes
t Dev
ice
(Who
le B
lood
)IM
A-40
2AB
ON B
ioph
arm
(H
angz
hou)
Co.
Ltd
0N
A1
1x
23
115
pipe
tte
Cass
ette
Engl
ish
Cass
ette
, Pip
ette
, Buf
fer,
Desi
ccan
t (no
col
our
indi
cato
r)
BIOC
REDI
T M
alar
ia p
f(HRP
II)
HR0
100
Rapi
Gen
Inc.
1N
A1
2x
24
130
capi
llary
tu
beCa
sset
teEn
glis
hCa
sset
te, C
apill
ary
Tube
s, Bu
ffer
, Des
icca
nt (n
o co
lour
indi
cato
r)
Firs
tSig
n™ M
alar
ia P
f21
00CB
-25
Uni
med
Inte
rnat
iona
l Inc
.1
01
2x
13
120
loop
Cass
ette
Engl
ish
Cass
ette
, Tra
nsfe
r Loo
p, L
ance
t, Al
coho
l Sw
abs,
Buff
er, D
esic
cant
(no
colo
ur in
dica
tor)
ICT
MAL
ARIA
P.F.
ML0
4IC
T IN
TERN
ATIO
NAL
10
12
x2
41
15pi
pett
eCa
sset
teEn
glis
hCa
sset
te, P
ipet
te, L
ance
t, Al
coho
l Sw
abs,
Buff
er,
Desi
ccan
t (Co
lor-
Chan
ge)
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN P
.f 53
5-11
IND
Diag
nost
ics
Inc.
1N
A1
2x
24
125
naCa
sset
teEn
glis
hCa
sset
te, B
uffe
r, De
sicc
ant (
no c
olou
r ind
icat
or)
Mal
eris
can
® M
alar
ia P
.f An
tigen
Tes
tM
AT-P
F-50
Bhat
Bio
-Tec
h In
dia (
Pte.)
Ltd.
1N
A1
2x
24
120
pipe
tte
Cass
ette
Engl
ish
Cass
ette
, Pip
ette
, Buf
fer,
Desi
ccan
t (no
col
our
indi
cato
r)
One
Step
Mal
aria
P.F
Tes
t (Ca
sset
te)
5223
52Bl
ue C
ross
Bio
-Med
ical
(B
eijin
g) C
o., L
td.
1N
A1
2x
24
115
NA
Cass
ette
Engl
ish
Cass
ette
, Buf
fer,
Desi
ccan
t (no
col
our i
ndic
ator
)
Para
chec
k® P
f-Ra
pid
Test
for
P. fa
lcip
arum
Mal
aria
Dev
ice
(Ver
.3)
3030
1025
Orch
id B
iom
edic
al
Syst
ems
10
12
x2
41
20lo
opCa
sset
teEn
glis
hCa
sset
te, T
rans
fer L
oop,
Lan
cet,
Alco
hol S
wab
, Bu
ffer
, Des
icca
nt (n
o co
lour
indi
cato
r)Pa
rach
eck®
Pf-
Rapi
d Te
st fo
r P.
falc
ipar
um M
alar
ia D
ipst
ick
(Ver
.3)
3030
2025
Orch
id B
iom
edic
al
Syst
ems
10
01
x1
21
20lo
opDi
pstic
kEn
glis
hDi
pstic
k, T
rans
fer L
oop,
Lan
cet,
Alco
hol S
wab
, Bu
ffer
, Des
icca
nt (n
o co
lour
indi
cato
r)Tr
usty
™ M
alar
ia A
ntig
en P
.f. te
stA0
3-11
-322
Artr
on L
abor
ator
ies
Inc.
1N
A1
2x
24
120
NA
Cass
ette
Engl
ish
Cass
ette
, Buf
fer,
Desi
ccan
t (no
col
our i
ndic
ator
)
Won
dfo
One
Step
Mal
aria
P.f
Test
W
37-
CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
11
13
x2
51
15lo
opCa
sset
teEn
glis
hCa
sset
te, T
rans
fer L
oop,
Lan
cet (
retr
acta
ble
Nee
dle)
, Alc
ohol
Sw
ab, B
uffe
r, De
sicc
ant (
no
colo
ur in
dica
tor)
Pf a
nd P
anAB
ON™
Plu
s M
alar
ia P
.f/Pa
n Ra
pid
Test
De
vice
(Who
le B
lood
)IM
A-T4
02AB
ON B
ioph
arm
(H
angz
hou)
Co.
Ltd
1N
A1
2x
24
215
pipe
tte
Cass
ette
Engl
ish
Cass
ette
, Pip
ette
, Buf
fer D
esic
cant
(no
colo
ur
indi
cato
r)AZ
OG M
alar
ia p
f (H
RPII)
/pf (
LDH
)/ (P
AN-
LDH
) Ant
igen
Det
ectio
n De
vice
MFV
-124
FAZ
OG, I
NC.
1N
A1
2x
24
120
NA
Cass
ette
Engl
ish
Cass
ette
, Buf
fer,
Desi
ccan
t (no
col
our i
ndic
ator
)
Core
Mal
aria
Pan
Pf
MAL
-190
024
Core
Dia
gnos
tics
Ltd.
10
12
x1
31
20lo
opCa
sset
teEn
glis
hCa
sset
te, T
rans
fer L
oop,
Lan
cet,
Alco
hol S
wab
s, De
sicc
ant (
no c
olou
r ind
icat
or)
EzDx
™ M
alar
ia P
an/P
f Rap
id T
est
Dete
ctio
n ki
tRK
MAL
001
Advy
Che
mic
al (A
ffili
ate
of B
hara
t Ser
ums
&
Vacc
ines
Ltd
. )1
NA
12
x2
41
20pi
pett
eCa
sset
teEn
glis
hCa
sset
te, P
ipet
te, B
uffe
r, De
sicc
ant (
no c
olou
r in
dica
tor)
Firs
tSig
n™ P
araV
iew
(Pan
+Pf)
2101
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
10
12
x1
31
20lo
opCa
sset
teEn
glis
hCa
sset
te, T
rans
fer L
oop,
Lan
cet,
Alco
hol S
wab
s, Bu
ffer
, Des
icca
nt (n
o co
lour
indi
cato
r)
Hum
asis
Mal
aria
P.f/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is, C
o., L
td.
1N
A1
2x
24
130
loop
Cass
ette
Engl
ish,
Fr
ench
, Sp
anis
h
Cass
ette
, Tra
nsfe
r Loo
p, B
uffe
r, De
sicc
ant (
no
colo
ur in
dica
tor)
ICT
MAL
ARIA
COM
BOM
L02
ICT
INTE
RNAT
ION
AL1
01
2x
23
115
pipe
tte
Cass
ette
Engl
ish
Cass
ette
, Pip
ette
, Buf
fer,
Lanc
et, A
lcoh
ol S
wab
, De
sicc
ant (
Colo
r Cha
nge)
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN P
.f/Pa
n TE
ST53
5-10
IND
Diag
nost
ics
Inc.
1N
A1
2x
24
125
NA
Cass
ette
Engl
ish
Cass
ette
, Buf
fer,
Desi
ccan
t (no
col
our i
ndic
ator
)
Mal
aria
Pf/
PAN
GM
004
Gen
omix
Mol
ecul
ar
Diag
nost
ics
Pvt.L
td.
1N
A1
2x
24
120
pipe
tte
Cass
ette
Engl
ish
Cass
ette
, Pip
ette
, Buf
fer,
Lanc
ets,
Desi
ccan
t (no
co
lour
indi
cato
r)M
alar
ia p
f (H
RP II
)/PAN
(pLD
H) A
ntig
en
Dete
ctio
n Te
st D
evic
e1-
13-1
01-1
Uni
ted
Biot
ech,
Inc.
1
NA
12
x2
41
20N
ACa
sset
teEn
glis
hCa
sset
te, B
uffe
r, De
sicc
ant (
non-
col
or-c
hang
e)
Mal
eris
can®
Mal
aria
P.f/
PAN
(Pv,
Pm, P
o)
3 Li
ne A
ntig
en T
est
MAT
-PF/
PAN
-50
Bhat
Bio
-Tec
h In
dia
(Pte
.) Lt
d.1
NA
12
x2
41
20pi
pett
eCa
sset
teEn
glis
hCa
sset
te, P
ipet
te, B
uffe
r, De
sicc
ant (
no c
olou
r in
dica
tor)
Res
ult
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)52 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 53
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
Bloo
d sa
fety
aIn
stru
ctio
n qu
ality
bCo
m-
bine
d sc
ore
(max
. 5)
Num
ber
of t
imed
st
eps
Tota
l tim
e to
re
sult
Bloo
d tr
ansf
er
devi
ce
Form
atLa
ngua
ge
of
inst
ruct
ion
Item
s in
clud
ed in
pac
kage
cM
ixin
g we
lls
invo
lved
Retra
ct-
able
ne
edle
St
rip
Expo
sed
Scor
e (m
ax. 3
) No
di
agra
mDi
agra
m
of re
sult
Diag
ram
of
resu
lt
& m
etho
dSc
ore
(max
. 2)
MeD
iPro
Mal
aria
Ag
HRP
2/pL
DH C
ombo
IR-0
051K
Form
osa
Biom
edic
al
Tech
nolo
gy C
orp.
0N
A1
1x
23
115
pipe
tte
Cass
ette
Engl
ish
Cass
ette
, Pip
ette
, Buf
fer,
Desi
ccan
t (no
col
our
indi
cato
r)
Nan
oSig
n M
alar
ia p
f/pa
n Ag
3.0
RMAP
10Bi
olan
d Lt
d.1
01
2x
24
115
Loop
Cass
ette
Engl
ish
Cass
ette
, Tra
nsfe
r Loo
p, B
uffe
r, La
ncet
, De
sicc
ant (
no c
olou
r ind
icat
or)
OnSi
te P
f/Pa
n Ag
Rap
id T
est
R011
3CCT
K Bi
otec
h, In
c.1
NA
12
x2
41
30pi
pett
eCa
sset
teEn
glis
hCa
sset
te, P
ipet
te ,
Buff
er, D
esic
cant
(no
colo
ur
indi
cato
r)
Para
HIT
- T
otal
Ver
. 1.0
(Dip
stic
k)55
IC20
3-10
Span
Dia
gnos
tics
Ltd.
10
01
x2
31
25ca
pilla
ry
tube
Dips
tick
Engl
ish
Dips
tick,
Cap
illar
y Tu
bes,
Alco
hol S
wab
s, La
ncet
s, Bu
ffer
, Tes
t Tub
es, D
esic
cant
(Col
or
Chan
ge)
Para
HIT
- T
otal
Ver
. 1.0
(Dev
ice)
55IC
204-
10Sp
an D
iagn
ostic
s Lt
d.1
01
2x
24
125
capi
llary
tu
beCa
sset
teEn
glis
hCa
sset
te, C
apill
ary
Tube
s, Al
coho
l Sw
abs,
Lanc
ets,
Buff
er, D
esic
cant
(Col
or C
hang
e)Pa
rasc
reen
® -
Rapi
d te
st fo
r Mal
aria
Pa
n/Pf
5031
0025
Zeph
yr B
iom
edic
als
10
12
x1
31
20lo
opCa
sset
teEn
glis
hCa
sset
te, T
rans
fer L
oop,
Lan
cet,
Alco
hol S
wab
s, Bu
ffer
, Des
icca
nt (C
olor
-Cha
nge)
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
an05
FK66
Stan
dard
Dia
gnos
tics
Inc.
1
NA
12
x1
31
15N
ACa
sset
te
Engl
ish,
Fr
ench
, Sp
anis
h,
Port
ugue
se
Cass
ette
, Buf
fer,
Desi
ccan
t(no
colo
ur in
dica
tor)
Pf a
nd P
vCa
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/Pv
) CO
MBO
G01
61Ac
cess
Bio
, Inc
.1
01
2x
24
120
pipe
tte
Cass
ette
Engl
ish
Cass
ette
, Pip
ette
, Buf
fer,
Alc.
Sw
abs,
Lanc
ets,
Desi
ccan
t (no
col
our i
ndic
ator
)Ca
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/VO
M)
COM
BOG
0171
Acce
ss B
io, I
nc.
10
12
x2
41
20pi
pett
eCa
sset
teEn
glis
hCa
sset
te, P
ipet
te, B
uffe
r, Al
c. S
wab
s, La
ncet
s, De
sicc
ant (
no c
olou
r ind
icat
or)
Falc
iVax
™ -
Rap
id te
st fo
r Mal
aria
Pv/
Pf
5030
0025
Zeph
yr B
iom
edic
als
10
12
x1
31
20lo
opCa
sset
teEn
glis
hCa
sset
te, T
rans
fer L
oop,
Lan
cet,
Alco
hol S
wab
s, Bu
ffer
, Des
icca
nt (
Colo
r-Ch
ange
)
HiS
ens
Mal
aria
Ag
P.f/
P.v
Com
bo C
ard
HR3
123
HBI
Co.
, Ltd
.1
NA
12
x2
41
20pi
pett
eCa
sset
teEn
glis
hCa
sset
te, B
uffe
r, Pi
pett
e, D
esic
cant
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colo
ur
indi
cato
r)
HiS
ens
Mal
aria
Ag
P.f/
VOM
Com
bo C
ard
HR3
323
HBI
Co.
, Ltd
.1
NA
12
x2
41
20pi
pett
eCa
sset
teEn
glis
hCa
sset
te, B
uffe
r, Pi
pett
e, D
esic
cant
(no
colo
ur
indi
cato
r)
Hum
asis
Mal
aria
P.f/
P.v
Antig
en T
est
AMFV
-702
5H
umas
is, C
o., L
td.
1N
A1
2x
24
130
loop
Cass
ette
Engl
ish,
Fr
ench
, Sp
anis
h
Cass
ette
, Tra
nsfe
r Loo
p, B
uffe
r, De
sicc
ant (
no
colo
ur in
dica
tor)
Mal
aria
Pf/
PvG
M00
2G
enom
ix M
olec
ular
Di
agno
stic
s Pv
t.Ltd
.1
NA
12
x2
41
20pi
pett
eCa
sset
teEn
glis
hCa
sset
te, P
ipet
te, B
uffe
r, La
ncet
s, De
sicc
ant (
no
colo
ur in
dica
tor)
Mal
aria
pf (
HRP
II) /
pv
(pLD
H) A
ntig
en
Dete
ctio
n Te
st D
evic
e1-
13-1
01-3
Uni
ted
Biot
ech,
Inc.
1
NA
12
x2
41
20N
ACa
sset
teEn
glis
hCa
sset
te, B
uffe
r, De
sicc
ant (
no c
olou
r ind
icat
or)
Med
isen
sor M
alar
ia H
RP2/
pLDH
(Pf/
Pv)
COM
BOM
161
Med
isen
sor,
Inc.
10
12
x2
41
20pi
pett
eCa
sset
teEn
glis
hCa
sset
te, P
ipet
te, B
uffe
r, A
lc. S
wab
s, La
ncet
s, De
sicc
ant (
no c
olou
r ind
icat
or)
Med
isen
sor M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) CO
MBO
M17
1M
edis
enso
r, In
c.1
01
2x
24
120
pipe
tte
Cass
ette
Engl
ish
Cass
ette
, Pip
ette
, Buf
fer,
Alc
. Sw
abs,
Lanc
ets,
Desi
ccan
t (no
col
our i
ndic
ator
)
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
52Bl
ue C
ross
Bio
-Med
ical
(B
eijin
g) C
o., L
td.
1N
A1
2x
24
115
NA
Cass
ette
Engl
ish
Cass
ette
, Buf
fer,
Desi
ccan
t (no
col
our i
ndic
ator
)
OnSi
te P
f/Pv
Ag
Rapi
d Te
stR0
112C
CTK
Biot
ech,
Inc.
1N
A1
2x
24
130
pipe
tte
Cass
ette
Engl
ish
Cass
ette
, Pip
ette
, Bu
ffer
, Des
icca
nt (n
o co
lour
in
dica
tor)
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/Pv
) CO
MBO
G01
61Ac
cess
Bio
Eth
iopi
a1
01
2x
24
120
pipe
tte
Cass
ette
Engl
ish
Cass
ette
, Pip
ette
, Buf
fer,
Alc
. Sw
abs,
Lanc
ets,
Desi
ccan
t (no
col
our i
ndic
ator
)Pa
raCa
re M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) CO
MBO
G01
71Ac
cess
Bio
Eth
iopi
a1
01
2x
24
120
pipe
tte
Cass
ette
Engl
ish
Cass
ette
, Pip
ette
, Buf
fer,
Alc
. Sw
abs,
Lanc
ets,
Desi
ccan
t (no
col
our i
ndic
ator
)
Tabl
e 6
(con
tinue
d)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)54
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
Bloo
d sa
fety
aIn
stru
ctio
n qu
ality
bCo
m-
bine
d sc
ore
(max
. 5)
Num
ber
of t
imed
st
eps
Tota
l tim
e to
re
sult
Bloo
d tr
ansf
er
devi
ce
Form
atLa
ngua
ge
of
inst
ruct
ion
Item
s in
clud
ed in
pac
kage
cM
ixin
g we
lls
invo
lved
Retra
ct-
able
ne
edle
St
rip
Expo
sed
Scor
e (m
ax. 3
) No
di
agra
mDi
agra
m
of re
sult
Diag
ram
of
resu
lt
& m
etho
dSc
ore
(max
. 2)
RAPI
D 1-
2-3®
HEM
A CA
SSET
TE M
ALAR
IA
PF/P
V TE
STM
AL-P
FV-
CAS/
25(1
00)
Hem
a Di
agno
stic
Sys
tem
s, LL
C1
01
2x
24
120
loop
Cass
ette
Engl
ish
Cass
ette
, Tra
nsfe
r Loo
p, B
uffe
r, Al
coho
l Sw
abs,
Desi
ccan
t (no
col
our i
ndic
ator
)RA
PID
1-2-
3® H
EMA
EXPR
ESS®
MAL
ARIA
PF
/PV
TEST
MAL
-PF
V-02
07H
ema
Diag
nost
ic S
yste
ms,
LLC
1N
A1
1x
23
115
NA
Mod
ified
di
pstic
k En
glis
hDe
vice
, Buf
fer,
Desi
ccan
t (no
col
our i
ndic
ator
), Co
ver
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
v05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
1N
A1
2x
13
115
NA
Cass
ette
Engl
ish
Cass
ette
, Buf
fer,
Desi
ccan
t(no
colo
ur in
dica
tor)
Trus
ty™
Mal
aria
Ant
igen
P.f.
/p.v.
test
A03-
12-3
22Ar
tron
Lab
orat
orie
s In
c.1
NA
12
x2
41
20N
ACa
sset
teEn
glis
hCa
sset
te, B
uffe
r, De
sicc
ant (
no c
olou
r ind
icat
or)
Pan
only
AZOG
hCG
Mal
aria
Det
ectio
n Te
st D
evic
eM
PT-1
24AZ
OG, I
NC.
1N
A1
2x
24
120
NA
Cass
ette
Engl
ish
Cass
ette
, Buf
fer,
Desi
ccan
t (no
col
our i
ndic
ator
)
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
a M
ixin
g w
ells
invo
lved
: Yes
=0; N
o=1;
Ret
ract
able
nee
dle:
Yes
=1; N
o=0;
Str
ip e
xpos
ed (n
ot w
ithin
car
d or
cas
sett
e): E
xpos
ed=0
, Cov
ered
=1b
No
diag
ram
s=0;
Dia
gram
of t
he re
sults
=1; D
iagr
am o
f res
ult a
nd m
etho
d=2
c Th
ese
are
not n
eces
saril
y st
anda
rd k
it co
nten
ts. P
rocu
rers
sho
uld
verif
y w
ith th
e m
anuf
actu
rers
wha
t mat
eria
ls a
ccom
pany
test
kits
and
ens
ure
they
pro
cure
all
the
requ
ired
acce
ssor
ies
at th
e sa
me
time.
d
Inst
ruct
ions
pam
phle
t not
incl
uded
in th
e or
igin
al p
acka
ging
Tabl
e 6:
Eas
e-of
-use
des
crip
tion
of 4
8 m
alar
ia R
DTs
incl
uded
in R
ound
4: W
HO
Mal
aria
RDT
Pro
duct
Tes
ting
(con
tinue
d)
dis
cUss
ion
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 55
14. discUssion of keY findings
Thisreportdescribestheperformanceofmanyoftheavailablemalariaantigen-detectingRDTsmanufacturedundertheISO13485:2003qualitystandard.MalariaRDTshavethepotentialtoprovideahugestepforwardinthemanagementoffebrileillnessinmalaria-endemicareas.Tobeusefulinthiscontext,malariaRDTsmusthaveadequate:i. sensitivity,todetectnearlyallclinically-significantcases
ofmalaria;
ii. specificity,toaccuratelydiscriminatenon-malarialfebrileillnessfrommalaria,toensureappropriatemanagementandaccuratediseasemonitoring;
iii. stability,foraccuracytobemaintainedaftertransportandstorageinambientconditions;
iv. ease-of-useandsafety,toallowsafeandcorrectprepara-tion,andaccurateinterpretationofresults.
InordertoassistNationalMalariaControlProgrammesandotherprocurementagenciesintheselectionofproductsappropriatetotheirneeds,malariaRDTswereevaluatedintermsofthesefourmajorrequirements.ThepanelusedsuccessfullydiscriminatedbetweentheRDTsevaluated,showingaconsiderablerangeofperformance.Importantly,anumberofproductsdemonstratedahighrateofantigendetectioncombinedwithalowfalse-positiverateandgoodheat(thermal)stability,attributesessentialiftheyaretobereliedonasabasisformalariatreatmentdecisionsinmostendemicpopulations.DeservingspecialnoteinRound4,isthemarkedimprovementinPDSofmanyproductsre-submittedforevaluationfrompreviousrounds(TableS1,S3).Againstthe200parasites/µlpanels,themeanandmedianPDSofthe13re-submittedproductsrosefrom84.0%to87.7%and85.0%to89.8%,respectivelyforP. falciparumdetection.ForthenineproductswhichdetectedP. vivax,themeanandmedianrosefrom59.1%to72.6%andfrom80.0%to88.2%,respectively.
Theresultsforre-submittedproductsinRound4replacethoseofpreviousrounds.Theprogrammeadherestoaworkingdefinitionof‘product’whichlaysoutspecificcondi-tions/modificationsthatdenoteachangeinproduct.
OveralltheRound4meanPDSforlowdensitiesP. falciparumandP.vivaxsampleswas81.6%and51.3%,respectively.ThisrepresentsanincreaseforP. falciparumcomparedwithpreviousRounds1,2and3(67.2%,69.9%,75.5%,respectively).ForP. vivaxthemeanPDSof51.3%wascomparabletopreviousrounds,i.e.36.0%,58.9%and47.1%inRounds1,2and3,respectively.Inaddition,themeanfalse-positiveratewas4.5%andislowerthan5.9%inRounds3;furthermore,themedianFPratefellfrom1.8%,2.9%,1.0%(Rounds1,2and3)to0.6%inRound4.Overall,thetrendistowardsbetterperformingRDTsassociatedwiththeperiodoftheWHO-FINDRDTEvaluationProgramme.
TheprincipalresultsinthisreportarepresentedinTables3and4.ThetablesgrouptheRDTsbytype,dependingonwhattheyaresupposedtodetect,e.g.P. falciparumonly,P. falci-parumandnon-falciparumspecies,aswellasP. falciparumandP.vivaxorPvom-specificandpan-only, orallmalariaspecieswithoutdiscrimination.NotethattheevaluationonlytestsagainstP. falciparumandP. vivaxsamples,anddoesnotthereforeindicatewhetheraproductintendedtodetectotherspeciescandoso.Paneldetectionscoresatbothhighandlowparasiteconcentrationsarepresented,asarefalse-positiverates,andthepercentageofinvalidtestresults.Testsineachcategoryarelistedalphabetically,buttheresultsarecolour-codedtoassistthereaderinquickinterpretationofthedata.Thesecolourcodesareintendedtobeusedtoquicklycompareperformanceinthedifferentcategoriesandnotasperformancecut-offstoguidetestselectionorprocurement.WHOrecommendationsforprocurementshouldbereferredtoregardingthesecriteria1.Whenchoosinganappropriateproduct,itisimportanttoalsoreviewthestabilityresults(Table5)inthecontextoftheexpectedconditionsoftransportandstorageoftheRDTsinthefield.
Thisevaluationisperformedagainstastandardizedpanelofcultured P. falciparum andfrozenbloodsamplesbyexpe-riencedtechniciansinaresearchlaboratory,andisnotthereforeafieldevaluationofRDTaccuracyinaspecificepidemiologicalcontextinthehandsofintendedusers.Thepanelisdesignedtomimicfreshbloodsamplesfromactualcasesascloselyaspossible,whileallowingdirectcomparisonofalargenumberofproductssimultaneouslyinamannerthatcontrolsforconfoundingfactorsandiscalibratedtoalevellikelytodiscriminateperformancedifferencesofvariousproducts.Ininterpretingtheresults,itisthereforeimportantthatthefollowingdiscussionpointsaretakenintoaccount.
14.1. panel detection score (pds) and its relationship to sensitivity EvaluationoftheRDTsagainstthePhase2wild-typeparasitepanelwithparasitedensitiesof200parasites/µl(Figures8,9)revealedawiderangeoffrequencyandconsistencyofantigendetectionbetweenproducts,recordedasthe“PanelDetectionScore”(PDS).Asexpected,testingathigherparasitedensities(2000[or5000]parasites/µl)resultsinsmallerdifferencesinperformance.Astwotestseachfromtwodifferentlotsweretestedat200parasites/µl,andasallfourresultshadtobepositiveforasampletobeconsidereddetectedbyanRDT,apositiveresultindicatedboththeabilityofaproducttodetectthetargetantigeninthesample,andtodothisconsistently(bothtestsfrombothlots).Parasitedensitiesofaround200parasites/µlshouldbedetectedtoensurehighfieldsensitivityforclinically-significantmalariainfectioninmanymalaria-endemicpopulations(6).
1 Informationnoteoninterimselectioncriteriaforprocurementofmalariarapiddiagnostictests(RDTs)(April2012)http://www.who.int/entity/malaria/diagnosis_treatment/diagnosis/RDT_selec-tion_criteria.pdf(accessed15October,2012)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)56
ThePDSagainstthepanelsusedinthisevaluationisexpectedtodifferfromthetestsensitivityinaspecificclinicalsettingforfivemainreasons.i. Performancemayvarybetweenlotsorbatchesofthesame
product.Variabilityinlotperformanceisanissuewithalldiagnostics,anditcannotbeguaranteedthattheresultsfoundherewillpredictresultsfromsubsequentRDTlots.Itisimportanttotestlotspriortodistributiontothefield,toensurethatexpectedperformanceismaintained(seeSection15.2).
ii. Inclinicalsettings,patientsshowawidevarietyofparasitedensities,therangeofwhichwilldependonthelocalepidemiologyofthedisease.Themagnitudeoftheparasitedensityinthepopulationtestedaffectstheclinicalsensitivityofthetest.PDSagainstthetestpanelofbloodsamplesdilutedto200parasites/µlarelikelytounderestimatetheclinicalsensitivityofanRDTinareasofhigh-transmissionwheresymptomaticpatientsoftenhavemuchhigherparasitedensitiesintheirblood.Manyteststhatshowedonlymoderatedetectionofthe200parasites/µlpanelmayperformwellinsuchsettings,asindicatedbythebetterPDSofmostprod-uctsagainstthepanelsetat2000parasites/µl. Importantly,when interpretingFiguresS1,S2,7-9,andthecolourcodinginTables3,4, the small differ-ences in panel detection scores found among the better-performing RDTs in this evaluation are unlikely to result in noticeable differences in clinical sensi-tivity, and other issues such as stability, cost, prior experience and training of the intended users, ease of use (Annex 5b) and manufacturing capacity may be equally important factors in test selection. TakingintoconsiderationtheparasitedensityofthetargetpopulationsandthelikelyfieldsensitivityofRDTs,itisimportanttonotethat,eveninareaswithhightransmissionandstrongmalariaimmunity,populationsmayincludeindividualswithlowparasitedensitiesbutclinicallysignificantinfections(e.g.youngchildren,preg-nantwomen,thoseregularlyusingbednets,immigrants,andotherswithreducedimmunity).Theabilitytodetectlowparasitedensityinfectionsreliably,therefore,remainsimportantinthesecases.Assomecountriesmovetowardselimination,populationimmunitywilldecreaseanditwillbecomeincreasinglyimportanttousediagnosticteststhatdetectlowparasitedensities(i.e.withhighPDSagainst200parasites/µlsamples).
iii. Performanceoftestsagainstthechallengepanelmaysometimesnotbepredictiveofsensitivityinclinicaltestingwhereantigenexpressionbycertainparasitepopulationsdiffersgreatlyfromthatinthepanel.Specifically,thereisevidencethatP. falciparumstrainsinsomeareasofSouthAmericadonotexpressHRP2antigensduetogenedeletions(19, 21). IfasignificantproportionofparasitesinagivenareadonotexpressHRP2,itisnecessarytousetestsdetectingothertargetantigens(eg.pLDHoraldolaseinthecaseofHRP2,3deletions).Thedistributionofsuchstrainsiscurrentlybeingmapped.Todate,noparasitepopulationswithhighfrequenciesofnon-expressionoftargetantigenshavebeendemonstratedoutsideofSouthAmerica.
iv. TheconditionsunderwhichRDTsaretransportedandstoredcanaltertheirfieldsensitivity.Thetestsusedinthisevaluationwereshippedandstoredunderconditionsintendedtosafeguardagainstdegradationcausedbyhightemperatureorotherextremeconditions.IfsimilarprecautionsarenottakenwithpurchasedRDTs,lossofperformancecouldresult.Ambienttemperaturesofstorageconditionsvarywidelyinsettingswherethesetestsarecommonlyused,asdotemperaturesduringtransport,andrequirementsforheatstabilityofaproductwillthereforediffer.Testsshouldbetransportedandstoredwellwithinthetemperaturerangerecommendedbythemanufacturer,andextremesoftemperatureavoided(23, 24).
v. Diagnosticsensitivityandspecificityaredependentonthequalityofpreparationandinterpretationofthetests.Highlytrainedindividualsperformedallthetestinginthisproductevaluation.Inclinicalsettings,malariaRDTswilloftenbeusedbyhealthworkerswithlimitedtrainingandsupervision.Simplicityofdesignandclearly-interpretableresultswillhaveaninfluenceonensuringthatthetech-nicalproficiencyofaproducttranslatesintoaccuratediagnosisinthefield1.
14.2. false-positive rate and specificity False-positiveratesarereportedhereagainstapanelofclean-negativesamplestakenfromblooddonatedinlow-transmissionsettingsbypeoplewithoutmalariasymptoms.Inaddition,false-positiverateswerecalculatedagainstasmallernumberofsampleswithspecificcharacteristicsthataffectthelikelihoodofafalse-positiveresultfromanimmuno-diagnostictest(e.g.rheumatoidfactor,anti-nuclearantibody),orthatmaybeofsignificanceinaspecificpopula-tioninmalaria-endemicareas(e.g.leishmaniasis,dengue).Theimportanceoftheseresultswillvarywiththeintendedareaofuse.Highfalse-positiveratesagainstsamplesofbloodfromdenguepatients,forexample,maynotbeasignificantfactortoconsiderinregionswheredenguedoesnotoccur.Inviewofthesmallnumberofsamplesineachcategoryinthisevaluation,theresults should be considered primarily as a guide to highlight potential cross-reactions that will require close monitoring if relevant to the target population.
Ingeneral,itispreferabletoprocureaproductwithalowrateoffalse-positivereactions.Inthecaseofmanydiagnostictests,atrade-offmustbemadebetweenapreferenceforahighrateofantigendetection(sensitivity)andalowfalse-positiverate(specificity).Thecontextinwhichthetestwillbeusedwillguidetherelativeimportanceofthesetwofactorsinchoosingoneproductoveranother.Overall,inthisevaluationtherewasnocorrelationoflowerPDS(lossofsensitivity)associatedwithlowfalse-positiverates(highspecificity).AnumberofproductsattainedbothahighPDSandalowfalse-positiverate.
1 Examplesavailablehere:http://www.wpro.who.int/sites/rdt/using_rdts/training/main.htm(accessed15October,2012);http://www.finddiagnostics.org/programs/malaria/find_activities/rdt-job-aids/(accessed15October,2012)
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 57
14.3. Heat (thermal) stability RDTsinthisevaluationwereheldfortwomonthsat35°Cand45°Cand75%humidityandthenretestedtoevaluatestabilityatthesetemperatures.Theimportanceofthermalstabilitywillvaryaccordingtotheambientconditionsunderwhichaproductisexpectedtobetransportedandstored.Thus,stabilityathightemperatureswillbevitalifanRDTistobestoredatcliniclevelinacountrywhereambienttemperaturescanreach45°Cinthehotseason,butlesscriticalinahigh-altitudeorcoolerenvironmentwheretemperaturesrarelyriseabove35°C.Manycommercially-availableRDTslist30°Casthemaximalstoragetemperature.Highertemperatureswereusedforthisevaluationbecauseitiscommonformalaria-endemiccountriestohavemaximumambienttemperaturesof35°Corabove,althoughtheuseofcoolstoragemethodscanallowstorageanduseofproductsdesignedforstoragebelowthesetemperatures.WheretransportandstorageofRDTsislikelytooccurathighambienttemperatures,heat(thermal)stabilityshouldbeseenasasignificantfactorinensuringmaintenanceofsensitivity.
HighhumiditywillacceleratethedegradationofmalariaRDTsandotherlateralflowtests.Alltheproductsinthisevaluationwerepackagedinindividualenvelopesthatcontainadesiccantandaredesignedtobemoisture-proof.Thisallowstheusertoopentheenvelopeofaspecifictestatthetimeofuse,limitingexposuretohighhumidity.Duringthestabilitytestingphaseofthisevaluation,RDTswerestoredat75%humidity.Thepackagingshould,ifingoodcondition,protectthecontentsfromexposuretohighhumidityduringstorage.Assuch,thestabilitytestingresultspresentedhereprovideanassessmentofboththestabilityoftheRDTandthequalityofitspackaging.
Currently,weareonlyabletoassessthestabilityoftestlinestodetectculturedP. falciparumsamples.Severalproductsshowedhighstabilityatthetemperaturesandtimeperiodsusedinthisevaluation.Ingeneral,inthisroundasinpreviousonespan-specificlines(pLDH)performedlesswellatbaselineandwerelessstablethanHRP2testlines,renderingpostincubationstabilityassessmentdifficulttointerpret.
Thoughtemperatureandhumiditywereheldconstantinthisevaluation,temperaturesinthefieldfluctuatewithtimeofdayandseason.Whiletwomonths’storageatasettemperaturecannotaccuratelypredictlong-termstabilityunderfieldconditions,lossofparasitedetectionoverthisperiodindicatesalikelihoodthatsignificantsensitivitywillbelostwhensimilarorhigherstoragetemperaturescompriseasignificantamountofthestoragetime,andindicateslikeli-hoodofahighersusceptibilitytodegradationduringshortperiodsofexposuretomuchhighertemperatures,suchasduringtransport(25, 26).
14.4. ease-of-use descriptionThesensitivityandspecificityofRDTresultsaredependentonthequalityofpreparationandinterpretationofthetest.Ingeneral,asimplerformatwithfewerstepsorfewerrequiredextraneousmaterialsislikelytobepreparedandinterpretedmorereliably.Thus,cassette-formatRDTsaregenerallymorereliablypreparedandinterpretedthanproductsindip-stickformat(27).Theextracostinvolvedinsuchaformatmaybeoffsetbytheadvantagesofincreasedaccuracyand,insomecases,lessadditionalequipmentrequiredtoperformthem.
Themethodofbloodtransferfromthepatienttothetestisimportantforthesafetyoftheuser,andfortheaccuracyofvolumeofbloodtransferred.DevicesforbloodtransferaresuppliedwithRDTs,andvarywidelyindesign,andaccuracy(20).Theperformanceofbloodtransferdeviceswasnotformallyassessedinthisevaluation,asbloodwastransferredfromatubebyamicro-pipettetoensurethemanufacturer-specifiedvolumewasused.Programmes procuring RDTs should consider the adequacy of the blood transfer device supplied, including previous experience of health workers and the costs and time required for re-training. Itmayoftenbeappropriatetodiscusswithmanufacturersthepossibilityofchangingthebloodtransferdevicefromthatnormallysupplied.
Clarityofresultsisimportanttotestinterpretation.Aclearlyvisible(intense)testlineislesslikelytobeoverlookedthanalinethatisbarelyvisible.Whilereadingproficiencyandadequateworkplacesshouldalwaysbeensured,healthworkersmaysometimeshavesub-optimalvisionorworkinconditionsofinadequatelighting.TheintensityofthelineofthetestbandiscloselyassociatedwiththePDSachievedbyRDTsinthisreport(TablesA4.2,A4.3).
Theimportanceofformatandsimplicityoftestdesignwilldependontheintendedend-users.Trainedlaboratorytechni-ciansmayhandleacomplicatedproceduremorereliablythanvillage-levelvolunteerswithlimitedsupervision.Inallcases,specificproficiency-basedtrainingandadequatesupervisionshouldbeincludedinanyRDT-baseddiagnosticprogramme,andclearinstructionsshouldbeprovidedinalanguageandformatappropriatefortheend-user(27–29).Annex 5b provides guidance on conducting a field-based ease-of-use assessment (Table A5.1) and illustrates examples of RDT anomalies (Figure A5.2).
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)58
14.5. inter-lot variability Thistestingprogrammeevaluatedonlytwoproductionlotsofeachproduct.MalariaRDTsarecomplexbiologicalproductsmadeofcomponentscommonlysuppliedfrommultiplesources,andsubjecttovariousconditionsduringmanufacturethatmayaffectthequalityofthefinalproduct.Allmanufac-turersenteredinthisevaluationprovidedatleastonecurrentISO13485:2003certificationforamanufacturingfacility.Thisstandardisdesignedtogiveassuranceofconsistencyofqualityofthefinalproduct,ifcorrectlyimplemented.Theresultspresentedhereindicatethatinter-lotvariabilitydoesoccur,andWHOstronglyrecommendsthatasampleofRDTsfromeachproductionlotbetestedpriortodisseminationtothefieldtoensureitmeetsanappropriatestandard.ThiscanbefacilitatedbyWHOthroughtwoWHO-recognizedlottestingfacilities(Section15.2).
Sinceinter-testvariabilityalsooccurs,thiswillbedetectedtosomeextentbyroutinelottesting.Ensuringmanufacturershavegoodmanufacturingstandardsshouldminimizethelikelihoodofinconsistenciesduetopoorpracticeinthemanufacturingprocess.Culture-basedpanels1thataresubsetsofthePhase1panelofthisevaluationareavailableasreferencestandardsformanufacturerstosettheirownlot-releasecriteriaagainst.
14.6. target antigens and speciesMalariaRDTsincludedinthisevaluationdetectoneormoreofthreeparasiteantigens(HRP2,pLDH,andaldolase)invariouscombinations.HRP2ispresentonlyinP. falciparum,whereasaldolaseandpLDHarepresentinallfourspeciesandmaybeusedaspanorall-speciestargets.SometestsusedifferencesinpLDHsequencesbetweenspeciesasameanstodifferentiateP. falciparumfromP. vivaxandotherspecies.ThereisconsiderableoverlapinthePDSofproductstargetingthedifferentantigensinthisevaluation.WhiletheproductswiththehighestPDSforP. falciparumtargetedHRP2,anumberofpLDH-detectingproductsdemonstratedhighPDSagainstP. vivax.Thethermalstabilityofteststargetingthesedifferentantigensalsooverlappedforhighparasitedensitysamples.
1 Toaccessthesepanels,[email protected],[email protected]@finddiagnostics.org.
ThechoiceofRDTshouldtaketargetantigenintoaccount:HRP2-detectingRDTsshouldnotbeusedinareaswherehighratesofHRP2non-expressionoccur(19,21).TestsdetectingonlyHRP2(withoutpLDHoraldolaselines)willhavelimitedutilitywherenon-falciparummalariaiscommon.pLDH(andpossiblyaldolase)RDTsmayhavefurtheradvantageswhereantigenpersistence(commonwithHRP2)mayresultinahighfalse-positiverateinareaswhereearlyretestingintheweeksimmediatelyaftertreatmentiscommon.
Therequiredsensitivityofatestmayalsovarywithspecies;alesssensitivetestmaybeacceptablefordetectionofP. vivaxcomparedtodetectionofP. falciparum,assevereoutcomesduetomisseddiagnosesarelesslikely.Useofasufficientlysensitivepan-specific-onlytestmaybeappropriateinareaswherebothP. falciparumandP. vivaxoccur,ifallinfectionsweretobemanagedinitiallyasaP. falciparuminfectionwithartemisinin-basedcombinationtherapy(ACT),butspecies-specificmonitoringdatawouldbelost.TestswithhighPDSforbothP. falciparumandP. vivaxweredemonstratedinthisandpreviousroundsofproducttesting(3, 4, 5).
Itshouldbenotedthatpan-speciestestswerenotevaluatedfordetectionofP. ovaleorP. malariaeinthisevaluationduetolackofsourcesofsuitablemono-speciesinfectionsoftheseparasites.
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 59
15. Using tHese resUlts to ensUre QUalitY of diagnosis in tHe field
Thisreportprovidesdatatoguidemalariacontrolandmanage-mentprogrammesinselectingproductslikelytoperformtoahighstandardintheparticularcontextsinwhichtheprogrammeoperates.Thefinaldecisiononproductselectionrequiresthatthisdatabeconsideredinasystematicway,takingintocontextthedistributionofparasitedensitiesofthetargetpopulationamongwhomthetestswillbeused,andtheexperienceandtrainingoftheintendedusers.Furtherinformationshouldbesoughtfromthemanufacturerandothersources.AnalgorithmtoguidethisprocessisgiveninAnnex5a1anddetailedguidanceisprovidedbyWHOelsewhere(7).
WhilemalariaRDTscanbeappliedinanumberofsettings,thegreatestpotentialforimpactonpublichealthisinextensionofaccesstoaccurate,parasite-baseddiagnosisofmalariatoregionsandpopulationswheregoodqualitymicroscopy-basedanalysisisimpracticaltomaintain.ThismakespossibletheimplementationofrecentWHOrecommendationsonuniversalparasite-baseddiagnosispriortoanti-malarialtherapy(2).Thiscurrentlyappliestomostpeopleatriskofmalariainendemiccountries(1).InmanysettingswhereRDTshavebeenintroduced,thetruerateofparasitaemiahasbeenfoundtobeconsiderablylowerthanexpected,allowinghealthsystemstoreducewastageofanti-malarialmedicinesandtofocusontheappropriatemanagementofnon-malarialcausesoffever,includingearlypneumoniaandsepsis.AsuccessfulRDTprogrammemustthereforeaddressnotjustmalariabutalsothemanagementofothercommonandseverefebrileillnessesthatoccurlocally,inthedifferentialdiagnosesofmalaria,ifthepotentialfullpublichealthimpactofanRDTprogrammeistobeachieved.
15.1. beyond procurementDiagnostictestsnormallyrepresentthestartingpointinahealthsystemintervention,andtheirusepresumesthatappropriatepatientmanagement,basedontesting,willfollow.Thus,successfulintroductionofRDTsrequirescarefulplanningbeyondrationalprocurementtoensureconsistent
1 Aninteractiveguidedesignedtohelpshort-listtestaccordingtoindividualprogrammeneeds,basedontheperformanceoftestsinrounds1-4oftheWHOProductTestingProgrammecanbefoundathttp://www.finddiagnostics.org/programs/malaria-afs/malaria/rdt_quality_control/product_testing/interactive-guide/index.jsp
suppliesofallnecessarymaterials(includinggloves,sharpsdisposalcontainers,andsuppliesrequiredforfurthercasemanagement),trainingofend-users,communitysensitization,andmonitoringofdiagnosticqualityandresults.Thisextendsbeyondmalariamanagementtomanagementofotherfebrilediseasesandhealthservicedeliverysystems,andrequiresanintegratedapproachwithotherhealthprogrammesimpactingonthemanagementoffebrileillness.
ThisreportprovidesinformationtoguideprocurementofRDTswithinthisframework.Anumberoffactorsbeyondperformancecharacteristicsreportedheremustinfluenceprocurementdecisions.Anexamplealgorithm,includingease-of-useassessment,isprovidedtoguidethesedecisionsinAnnexes5aand5b.
Details of implementation will vary widely betweenprogrammesaccordingtolocalcapacityandneeds.Furtherrecommendationsonbudgeting,planningandimplementationcanbefoundinAnnex6andintherelevantWHOguidancedocument(30).
15.2. lot testingComplementarytotheproducttestingprogramme,WHOandFINDcurrentlysupportlaboratoriesthatperformcontinualqualityassuranceofRDTsintheformoflottesting.Thisprogrammerespondstorequestsfromnationalmalariaprogrammes,manufacturers,andprocurementbodiestoassessthequalityofRDTlotspriortopurchaseorwhentheyarriveincountry,priortodispersaltothefieldandforclinicaluse.Testingisperformedagainstparasite-positiveandnega-tivepanelspreparedandcharacterizedinthesamewayasthepanelsusedinthisevaluation.Anumberofothernationalinstitutionshavealsodevelopedthiscapacity.Lot-testingreassurescountriesthattheproducttheyhavepurchasedisperformingtoahighstandardbeforedistribution,andhelpstoensurethatmanufacturersproduceconsistentlygoodlotsandimprovetheirproducts.
Countriesand/ormanufacturersshipbetween125–175RDTstotheregionalWHO-recognizedlottestingcentreswheretheyareevaluatedagainstasmallpanelofparasitesathighandlowparasitedensitiesandnegativesamples(Figure2-IPC,RITM).Theyaresubsequentlyincubatedatatemperatureclosetothemanufacturer’sspecifiedstoragetemperatureandretestedafter18months.Initialresultsareavailableafterfivedaysandthensentagainaftersubsequentretesting.Detailsoftheprotocolcanbefoundinthepublishedmethodsmanualforlottesting (18).Nationalmalariaprogrammesandprocuringagenciesareencouragedtoparticipateinthelottestingprogramme.
ToaccesslottestingthroughtheWHO-FINDprogramme,contact:[email protected]@finddiagnostics.orgatleast2weeksbeforeRDTsarereadyforshipment.Furtherinformationisavailableatwww.wpro.who.int/sites/rdt/who_rdt_evaluation/lot_testing.htm,orthroughwww.finddiagnostics.org
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)60
16. conclUsions
ThisreportaddstothelargedatasetonmalariaRDTperform-ancepublishedannuallysince2009afterthefirst,secondandthirdroundsofevaluations(3, 4, 5).TheproducttestingprogrammecontinuestobealandmarkinthefieldofmalariaRDTevaluationsintermsofthenumberofproductsevaluatedanditscomprehensiveness.Newlaboratorymethodshavebeendevelopedandvalidatedtosupportparasitecharac-terizationandthisworkgeneratednewfindingsregardingthevariationinantigencontentatsimilarparasitedensitiesandthevariationinthestructureandexpressionofHRPproteins.ThepublicationoftheWHOProductTestingRounds1-3resultshasimpactedontheprocurementpracticesofcountriesandprocurementagencies,andcontributedtotheshiftinthemalariaRDTmarkettowardsbetterperformingproducts(1).TheReportofRound4furtheraddstothenumberofwell-performingRDTsforwhichcomprehensiveperformancedataarenowavailable,andprovidesupdateddataon13productsthathavebeenre-submittedfollowingproductmodifications.
17. references
1. World Malaria Report 2011.Geneva,WorldHealthOrganization,2011.
2. Guidelines for the Treatment of Malaria, Second Edition.Geneva,WorldHealthOrganization,2010.
3. Malaria Rapid Diagnostic Test Performance : Results of WHO product testing of malaria RDTs: Round 1 (2008).Geneva,WorldHealthOrganization,2009.ISBN9789241598071
4. Malaria Rapid Diagnostic Test Performance : Results of WHO product testing of malaria RDTs: Round 2 (2009).Geneva,WorldHealthOrganization,2010.ISBN97892415994675
5. Malaria Rapid Diagnostic Test Performance : Results of WHO product testing of malaria RDTs: Round 3 (2010-11).Geneva,WorldHealthOrganization,2011.ISBN9789241502566.
6. Parasitological Confirmation of Malaria Diagnosis. Report of a WHO technical consultation Geneva, 6-8 October 2009. Geneva,WorldHealthOrganization,2010.ISBN9789241599412
7. Good practices for selecting and procuring rapid diagnostic tests for malaria.Geneva,WorldHealthOrganization,2011.ISBN9789241501125
8. Kolaczinski,J.,etal.,ComparisonoftheOptiMALrapidantigentestwithfieldmicroscopyforthedetectionofPlasmodium vivaxandP. falciparum:considerationsfortheapplicationoftherapidtestinAfghanistan. Ann Trop Med Parasitol,2004.98(1):p.15-20.
9. Richter,J.,etal.,Co-reactivityofplasmodialhistidine-richprotein2andaldolaseonacombinedimmuno-chromographic-malariadipstick(ICT)asapotentialsemi-quantitativemarkerofhighPlasmodium falciparumparasitaemia. Parasitol Res,2004.94(5):p.384-5.
10. Huong,N.M.,etal.,Comparisonofthreeantigendetectionmethodsfordiagnosisandtherapeuticmonitoringofmalaria:afieldstudyfromsouthernVietnam.Trop Med Int Health,2002.7(4):p.304-8.
11. Mason,D.P.,etal.,Acomparisonoftworapidfieldimmunochromatographicteststoexpertmicroscopyinthediagnosisofmalaria.Acta Trop,2002.82(1):p.51-9.
12. VandenBroek,I.,etal.,EvaluationofthreerapidtestsfordiagnosisofP. falciparumandP. vivaxmalariainColombia. Am J Trop Med Hyg,2006.75(6):p.1209-15.
13. McMorrow,M.L.,etal.,Challengesinroutineimple-mentationandqualitycontrolofrapiddiagnostictests
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formalaria--RufijiDistrict,Tanzania.Am J Trop Med Hyg,2008.79(3):p.385-90.
14. Wanji,S.,etal.,PerformanceandusefulnessoftheHexagonrapiddiagnostictestinchildrenwithasymp-tomaticmalarialivingintheMountCameroonregion.Malar J,2008.7:p.89.
15. Willcox,M.L.,etal.,Rapiddiagnostictestsforthehome-basedmanagementofmalaria,inahigh-transmissionarea. Ann Trop Med Parasitol,2009.103(1):p.3-16.
16. Belizario,V.Y.,etal.,FieldevaluationofmalariarapiddiagnostictestsforthediagnosisofP. falciparumandnon-P. falciparuminfections.Southeast Asian J Trop Med Public Health,2005.36(3):p.552-61.
17. WHO-TDR-FIND-CDC.Methods manual for product testing of malaria rapid diagnostic tests (Version Five).Geneva,WorldHealthOrganization,2012.
18. WHO-TDR-FIND.Methods Manual for Laboratory Quality Control Testing of Malaria Rapid Diagnostic Tests, Version Six.Geneva,WorldHealthOrganization,2010.
19. BakerJ,HoMF,PelecanosA,GattonM,ChenN,AbdullahS,AlbertiniA,ArieyF,BarnwellJ,BellD,etal,Globalsequencevariationinthehistidine-richproteins2and3ofPlasmodium falciparum:implicationsfortheperformanceofmalariarapiddiagnostictests.MalarJ2010,9:129.
20. HopkinsH,OyiboW,LuchavezJ,etal.Bloodtransferdevicesformalariarapiddiagnostictests:evalu-ationofaccuracy,safetyandeaseofuse.MalarJ2011;10:30
21. Gamboa,D.,M.F.Ho,etal. A large proportion of P. falciparum isolates in the Amazon region of Peru lack pfhrp2 and pfhrp3: implications for malaria rapid diagnostic tests. PLoS One,2010:5(1):e8091.
22. Methods for Field Trials of Malaria Rapid Diagnostic Tests.Manila, WorldHealthOrganizationRegionalOfficefortheWesternPacific,2009.
23. Transporting, Storing and Handling Malaria Rapid Diagnostic Tests at Central and Peripheral Storage Facilities. WorldHealthOrganization-WesternPacificRegionalOffice(WHO-WPRO),USAID|DELIVERPROJECT,FoundationforInnovativeNewDiagnostics(FIND),RollBackMalariaPartnership,President’sMalariaInitiative(PMI),andUNICEF.Arlington,Va.:USAID|DELIVERPROJECT,TaskOrder3;andManila:WHO-WPRO.2009.
24. Transporting, Storing and Handling Malaria Rapid Diagnostic Tests in Health Clinics. WorldHealthOrganization-WesternPacificRegionalOffice(WHO-WPRO),USAID|DELIVERPROJECT,FoundationforInnovativeNewDiagnostics(FIND),RollBackMalariaPartnership,President’sMalariaInitiative(PMI),andUNICEF.Arlington,Va.:USAID|DELIVER
PROJECT,TaskOrder3;andManila:WHO-WPRO.2009.
25. Jorgensen,P.,etal.,Malariarapiddiagnostictestsintropicalclimates:Theneedforacoolchain.American Journal of Tropical Medicine and Hygiene,2006.74(5).
26. Chiodini,P.L.,etal.,TheheatstabilityofPlasmodiumlactatedehydrogenase-basedandhistidine-richprotein2-basedmalariarapiddiagnostictests. Trans R Soc Trop Med Hyg,2007.101(4):p.331-7.
27. Rennie,W.,etal.,Minimisinghumanerrorinmalariarapiddiagnosis:clarityofwritteninstructionsandhealthworkerperformance.Trans R Soc Trop Med Hyg,2007.101(1):p.9-18.
28. Harvey,S.A.,etal.,Improving community health worker use of malaria rapid diagnostic tests in Zambia: package instructions, job aid and job aid-plus-training. Malar J,2008.7(1):p.160.
29. Tavrow,P.,EKnebel,LCogswell,Using quality design to improve malaria rapid diagnostic tests in Malawi, in Operations Research Results 1(4). 2000,PublishedfortheUnitedStatesAgencyforInternationalDevelopment(USAID)bytheQualityAssuranceProject(QAP):Bethesda,Maryland.
30. Universal Access to Malaria Diagnostic Testing: An operational manual.Geneva,WorldHealthOrganization,2011(ISBN9789241502092)
31. ThiamS,ThiorM,FayeB,NdiopM,DioufML,DioufMB,DialloI,FallFB,NdiayeJL,AlbertiniA,etal:Majorreductioninanti-malarialdrugconsumptioninsenegalafternation-wideintroductionofmalariarapiddiagnostictests.PLoSOne2011,6:e18419
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aria
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and
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Nan
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alar
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n Ag
RMAP
10F,P
pan-
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, HRP
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panp
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54
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Blue
Cro
ss B
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Ltd.
One
Step
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aria
P.F
Tes
t (Ca
sset
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5223
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2√
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Step
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aria
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Core
Dia
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osa
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rp.
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aria
Ag
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002
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Gua
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otec
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. Ltd
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alar
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st
W 3
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alar
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aria
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)64 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 65
Plas
mod
ium
sp
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s ta
rget
ed
(F =
P. f
alci
paru
mV
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viv
axO
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. ova
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. mal
aria
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ajor
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asm
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ence
and
typ
e of
bou
nd a
ntib
odyb
T1T2
T3C
Requ
ired
volu
me
(μl)
of
who
le
bloo
d
Buff
er
drop
s (μ
l)
Min
imum
tim
e to
re
sults
c (m
ins)
Max
i-m
um
read
ing
time
(min
s)
Resu
lts
Inte
rpre
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tiond
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ype A
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Form
at
type
e M
anuf
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Prod
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TIG
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TIG
EN P
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Inc.
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PV) C
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AN (p
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igen
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alar
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an/P
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ctat
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istid
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ein
2; p
v, P.
viv
ax; p
f, P.
falc
ipar
um
b Se
quen
ce w
hen
test
hel
d in
a h
oriz
onta
l pos
ition
and
the
sam
ple
wel
l is
at th
e fa
r rig
ht a
nd c
ontr
ol li
ne, f
ar le
ft
c Ti
me
from
pla
cem
ent o
f buf
fer,
or fr
om ‘i
nter
med
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’ ste
p, if
app
licab
led
See
Anne
x 2
e Fo
rmat
s inc
lude
: cas
sett
e (A
); ca
rd (B
); hy
brid
(C),
dips
tick
(D);
or o
ther
(E).
Each
pro
duct
shou
ld id
eally
be
acco
mpa
nied
by
all r
equi
red
mat
eria
ls
(lanc
et, p
ipet
te, e
tc.)
part
icul
arly
whe
n us
ed a
t the
vill
age
heal
th w
orke
r lev
el; h
owev
er, t
his
is o
ften
not
the
case
and
the
cont
ents
dep
end
on th
e re
ques
t of t
he p
rocu
ring
agen
t.
A Ca
sset
teB
Card
C Ca
sset
te h
ybrid
D
Dips
tick
E O
ther
CT
SA
CT
S
C T1 T2C
PPf
sam
ple
and
m
ixin
gw
ells
T1C T2
Ann
ex 1
(co
ntin
ued)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)66
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 67
annex 2: Malaria rdt guide to results interpretation
type a: Malaria generic pf rdt results guideResults Window:C=controlline;T=testlinewithboundHRP-2orPf-specificpLDHantibody.
C T
Negative Results:Oneline‘C’appearsintheresultswindow.
C T
Positive Results:P. falciparuminfection.Twolines‘C’and‘T’appearintheresultswindow.Testispositiveevenifthetestlineisfaint.
C T
Invalid Results:No‘C’lineappearsintheresultswindow.RepeatthetestusinganewRDTifnocontrollineappears.
C T
C T
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)68
type b: Malaria generic Major plasmodium species (pan) rdt results guide Results Window:C=controlline;T=testlinewithboundpan-specificpLDHoraldolaseantibody.
C T
Negative Results:Oneline‘C’appearsintheresultswindow.
C T
Positive Results: Plasmodiumspecies(P. falciparum, P. vivax, P.malariae, P.ovale)infection.Twolines‘C’and‘T’appearintheresultswindow.Testispositiveevenisthetestlineisfaint.
C T
Invalid Results:No‘C’lineappearsintheresultswindow.RepeatthetestusinganewRDTifnocontrollineappears.
C T
C T
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 69
type c: Malaria generic pan-pf rdt results guideResults Window:C=controlline;T1=testlinewithboundpLDHoraldolaseantibody;T2=testlinewithboundHRP2
and/orPfspecificpLDHantibody.
C T2T1
Negative Results:Onlyoneline‘C’appearsintheresultswindow.
C T1 T2
Positive Results:
P. falciparum:Twolines‘C’and‘T2”appearintheresultswindow.
C T1 T2
Non-falciparum infection(P. vivax, P.ovale, P.malariae)ormixedinfectionofthese:Twolines‘C’and‘T1”appearintheresultswindow.
C T1 T2
P. falciparumormixedinfection.Threelines‘C’,‘T1’and‘T2’appearintheresultswindow.
C T1 T2
Invalid Results:No‘C’lineappearsintheresultswindow.RepeatthetestusinganewRDTifnocontrollineappears.
C T1 T2
C T1 T2
C T1 T2
C T1 T2
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)70
type d: Malaria generic pf-pan rdt results guideResults Window:C=controlline;T1=testlinewithboundHRP2orPfspecificLDHantibody;
T2=testlinewithboundpLDHoraldolaseantibody.
C T2T1
Negative Results:Onlyoneline‘C’appearsintheresultswindow.
C T1 T2
Positive Results:
P. falciparum infection.Twolines‘C’and‘T1’appearintheresultswindow.
C T1 T2
Non-falciparum infection(P. vivax, P.ovale, P.malariae)ormixedinfectionofthese.Twolines‘C’and‘T2’appearintheresultswindow.
C T1 T2
P. falciparumormixedinfection.Threelines‘C’,‘T1’and‘T2’appearintheresultswindow.
C T1 T2
Invalid Results:No‘C’lineappearsintheresultswindow.RepeatthetestusinganewRDTifnocontrollineappears.
C T1 T2
C T1 T2
C T1 T2
C T1 T2
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 71
type e: Malaria generic pv-pf rdt results guideResults Window:C=controlline;T1=testlinewithboundP. vivaxspecificpLDH;
T2=testlinewithboundHRP2orPf-specificpLDHantibody.
C T2T1
Negative Results:Onlyoneline‘C’appearsintheresultswindow.
C T1 T2
Positive Results:
P. falciparuminfection.Twolines‘C’and‘T2’appearintheresultswindow.
C T1 T2
P. vivaxinfection.Twolines‘C’and‘T1’appearintheresultswindow.
C T1 T2
P. falciparum and P. vivax mixedinfection.Threelines‘C’,‘T1’and‘T2’appearintheresultswindow.
C T1 T2
Invalid Results:No‘C’lineappearsintheresultswindow.RepeatthetestusinganewRDTifnocontrollineappears.
C T1 T2
C T1 T2
C T1 T2
C T1 T2
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)72
type f: Malaria generic pf-pv rdt results guideResults Window:C=controlline;T1=testlinewithboundHRP2orPf-specificpLDHantibody;
T2=testlinewithboundP. vivaxspecificpLDH.
C T2T1
Negative Results:Onlyoneline‘C’appearsintheresultswindow.
C T1 T2
Positive Results:
P. falciparuminfection.Twolines‘C’and‘T1’appearintheresultswindow.
C T1 T2
P. vivaxinfection.Twolines‘C’and‘T2’appearintheresultswindow.
C T1 T2
P. falciparum and P. vivax mixedinfection.Threelines‘C’,‘T1’and‘T2’appearintheresultswindow.
C T1 T2
Invalid Results:No‘C’lineappearsintheresultswindow.RepeatthetestusinganewRDTifnocontrollineappears.
C T1 T2
C T1 T2
C T1 T2
C T1 T2
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 73
type g: Malaria generic pan-pv-pf rdt results guideResults Window:C=controlline;T1=testlineboundwithpLDHoraldolaseantibody;T2=testlinewithboundP. vivaxspecific
pLDH;T3=testlinewithboundHRP2orPf-specificpLDHantibody
C T2 T3T1
Negative Results:Onlyoneline‘C’appearsintheresultswindow.
C T1 T2 T3
Positive Results:
P. falciparuminfection.Twolines‘C’and‘T3’appearintheresultswindow.
C T1 T2 T3
P. vivaxinfection.Twolines‘C’and‘T2’appearintheresultswindow.
C T1 T2 T3
P. falciparum withorwithoutmixedinfectionwithP. ovaleorP. malariae.Threelines‘C’,‘T1’and‘T3’appearintheresultswindow.
C T1 T2 T3
P. falciparum andP. vivaxmixedinfection.Threelines‘C’,‘T2’and‘T3’appearintheresultswindow.
C T1 T2 T3
P. falciparum andP. vivaxmixedinfectionwithorwithoutP. ovaleand/orP. malariaeinfection.Fourlines‘C’,‘T1’,‘T2’and‘T3’appearintheresultswindow.
C T1 T2 T3
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)74
P. vivaxwithorwithoutP. ovaleand/orP. malariaeinfection.Threelines‘C’,‘T1’and‘T2’appearintheresultswindow.
C T1 T2 T3
P. malariaeand/orP. ovaleP. vivaxinfection.Twolines‘C’and‘T1’appearintheresultswindow.
C T1 T2 T3
Invalid Results:No‘C’lineappearsintheresultswindow.RepeatthetestusinganewRDTifnocontrollineappears.
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 75
type H: Malaria generic VoM1-pf rdt results guideResults Window:C=controlline;T1=testlineboundwithpLDHspecificfornon.P. falciparum(P. vivax, P. ovaleandP. malariae);
T2=testlinewithboundHRP2orPf-specificpLDHantibody
C T2T1
Negative Results:Onlyoneline‘C’appearsintheresultswindow.
C T1 T2
Positive Results:
P. falciparuminfection.Twolines‘C’and‘T2’appearintheresultswindow.
C T1 T2
P. falciparummixedinfection(withanyoneormoreofP. vivax, P. ovaleandP. malariae).Threelines‘C’,‘T1’and‘T2’appearintheresultswindow.
C T1 T2
Non-P. falciparum infection(P. vivax, P. ovaleandP. malariae)ormixedinfectionofthese.Twolines‘C’and‘T1’appearintheresultswindow.
C T1 T2
Invalid Results:No‘C’lineappearsintheresultswindow.RepeatthetestusinganewRDTifnocontrollineappears.
C T1 T2
C T1 T2
C T1 T2
C T1 T2
1 VOM-P. vivax, P. ovale, P. malariae
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)76
type i: Malaria generic pv rdt results guide Results Window:C=controlline;T=testlineboundwithP. vivaxspecificpLDH.
C T
Negative Results:Onlyoneline‘C’appearsintheresultswindow.
C T
Positive Results: P. vivaxinfection.Twolines‘C’and‘T’appearintheresultswindow.
C T
Invalid Results:No‘C’lineappearsintheresultswindow.RepeatthetestusinganewRDTifnocontrollineappears.
C T
C T
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 77
type j: Malaria generic pf-pf rdt results guideResults Window:C=controlline;T1=testlineboundwithpLDHspecificforP. falciparum;
T2=testlineboundwithHRP2.
C T2T1
Negative Results:Onlyoneline‘C’appearsintheresultswindow.
C T1 T2
Positive Results:
P. falciparuminfection.Twolines‘C’and‘T1’appearintheresultswindow.
C T1 T2
P. falciparum infection.Twolines‘C’and‘T2’appearintheresultswindow.
C T1 T2
P. falciparum infection.Threelines‘C’,‘T1’and‘T2’appearintheresultswindow.
C T1 T2
Invalid Results:No‘C’lineappearsintheresultswindow.RepeatthetestusinganewRDTifnocontrollineappears.
C T1 T2
C T1 T2
C T1 T2
C T1 T2
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)78
type k: Malaria generic pv-pf-pf rdt results guideResults Window:C=controlline;T1=testlinewithboundP. vivax-specificpLDH;T2=testlinewithboundHRP2orPf-specific
pLDHantibody;T3=testlinewithboundHRP2orPf-specificpLDHantibody.IfanRDThasboundHRP2antibodiesonT2thenT3willhaveboundPf-specific-pLDHandviceversa(T2Pfantigentarget≠T3Pfantigentarget).
C T2 T3T1
Negative Results:Onlyoneline‘C’appearsintheresultswindow.
C T1 T2 T3
Positive Results:
P. falciparum infection.Twolines‘C’and‘T3’appearintheresultswindow.
C T1 T2 T3
P. falciparum infection.Twolines‘C’and‘T2’appearintheresultswindow.
C T1 T2 T3
P. falciparuminfection.Threelines‘C’,‘T2’and‘T3’appearintheresultswindow.
C T1 T2 T3
P. falciparum infectionandP. vivaxmixedinfection.Threelines‘C’,‘T1’and‘T2’appearintheresultswindow.
C T1 T2 T3
P. falciparuminfectionandP. vivaxmixedinfection.Threelines‘C’,‘T1’and‘T3’appearintheresultswindow.
C T1 T2 T3
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 79
P. falciparum infectionandP. vivaxmixedinfection.Fourlines‘C’,‘T1’,‘T2’and‘T3’appearintheresultswindow.
C T1 T2 T3
P. vivax infection.Twolines‘C’and‘T1’appearintheresultswindow.
C T1 T2 T3
Invalid Results:No‘C’lineappearsintheresultswindow.RepeatthetestusinganewRDTifnocontrollineappears.
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)80
type l: Malaria generic pan-pf-pf rdt results guideResults Window:C=controlline;T1=testlinewithboundPAN-pLDHoraldolaseantibody;T2=testlinewithboundHRP2
orPf-specificpLDHantibody;T3=testlinewithboundHRP2orPf-specificpLDHantibody.IfanRDThasboundHRP2antibodiesonT2thenT3willhaveboundPf-specific-pLDHandviceversa(T2Pfantigentarget≠T3Pfantigentarget)
C T2 T3T1
Negative Results:Onlyoneline‘C’appearsintheresultswindow.
C T1 T2 T3
Positive Results:
P. falciparum infection.Twolines‘C’and‘T2’appearintheresultswindow.
C T1 T2 T3
P. falciparum infection.Twolines‘C’and‘T3’appearintheresultswindow.
C T1 T2 T3
P. falciparuminfection.Threelines‘C’,‘T2’and‘T3’appearintheresultswindow.
C T1 T2 T3
P. falciparuminfectionwithorwithoutmixedinfectionwithanyoneormoreofP. vivax,P. ovaleorP. malariae.Threelines‘C’,‘T1’and‘T2’appearintheresultswindow.
C T1 T2 T3
P. falciparuminfectionwithorwithoutmixedinfectionwithanyoneormoreofP. vivax,P. ovaleorP. malariae.Threelines‘C’,‘T1’and‘T3’appearintheresultswindow.
C T1 T2 T3
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 81
P. falciparum infectionwithorwithoutmixedinfectionwithanyoneormoreofP. vivax,P. ovaleorP. malariae.Fourlines‘C’,‘T1’,‘T2’and‘T3’appearintheresultswindow.
C T1 T2 T3
Non-P. falciparum infection(P. vivax,P. ovale,P. malariae)ormixedinfectionofthese.Twolines‘C’and‘T1’appearintheresultswindow.
C T1 T2 T3
Invalid Results:No‘C’lineappearsintheresultswindow.RepeatthetestusinganewRDTifnocontrollineappears.
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)82
anne
x 3:
pha
se 1
res
ults
Tabl
eA3.
1: L
ot v
aria
bilit
y in
pos
itive
res
ults
a ag
ains
t Ph
ase
1 P.
fal
cipa
rum
cul
ture
sam
ples
at
low
(20
0) a
nd h
igh
(200
0) p
aras
ite
dens
ity
(par
asit
es/µ
l)
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
P. f
alci
paru
m s
ampl
es (n
=20)
Tota
l pos
itive
res
ults
ret
urne
d
200
para
sites
/μl
2000
par
asite
s/μl
Lot
1Lo
t 2
Lot
1Lo
t 2
Test
1Te
st 2
No.
pos
itive
ag
reem
ents
b (m
ax=2
0)Te
st 1
Test
2N
o. p
ositi
ve
agre
emen
tsb
(max
=20)
Test
1Te
st 2
Pf o
nly
ABON
™ M
alar
ia P
.f. R
apid
Tes
t Dev
ice
(Who
le B
lood
)IM
A-40
2AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td7.
06.
05.
09.
09.
0 (9
)7.
019
.020
.0BI
OCRE
DIT
Mal
aria
pf(H
RP II
)H
R010
0Ra
piG
en In
c.20
.020
.020
.020
.020
.020
.020
.020
.0Fi
rstS
ign™
Mal
aria
Pf
2100
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
20.0
20.0
20.0
20.0
20.0
20.0
20.0
20.0
ICT
MAL
ARIA
P.F.
ML0
4IC
T IN
TERN
ATIO
NAL
4.0
2.0
0.0
4.0
1.0
(1)
0.0
16.0
18.0
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN P
.f 53
5-11
IND
Diag
nost
ics
Inc.
14.0
13.0
13.0
15.0
17.0
(17)
15.0
20.0
20.0
Mal
eris
can
® M
alar
ia P
.f An
tigen
Tes
tM
AT-P
F-50
Bhat
Bio
-Tec
h In
dia
(Pte
.) Lt
d.20
.017
.017
.017
.018
.0 (1
8)17
.020
.020
.0On
e St
ep M
alar
ia P
.F T
est (
Cass
ette
)52
2352
Blue
Cro
ss B
io-M
edic
al (B
eijin
g) C
o., L
td.
20.0
20.0
20.0
20.0
20.0
20.0
20.0
20.0
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipa
rum
Mal
aria
Dev
ice
(Ver
.3)
3030
1025
Orch
id B
iom
edic
al S
yste
ms
20.0
20.0
20.0
20.0
20.0
20.0
20.0
20.0
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipa
rum
Mal
aria
Dip
stic
k (V
er.3
)30
3020
25Or
chid
Bio
med
ical
Sys
tem
s 19
.017
.017
.018
.019
.0 (1
9)18
.020
.020
.0Tr
usty
™ M
alar
ia A
ntig
en P
.f. te
stA0
3-11
-322
Artr
on L
abor
ator
ies
Inc.
16.0
17.0
16.0
19.0
19.0
(19)
19.0
19.0
19.0
Won
dfo
One
Step
Mal
aria
P.f
Test
W
37-
CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
19.0
19.0
19.0
19.0
17.0
(17)
17.0
20.0
20.0
Pf a
nd P
anAB
ON™
Plu
s M
alar
ia P
.f/Pa
n Ra
pid
Test
Dev
ice
(Who
le B
lood
)IM
A-T4
02AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td19
.019
.019
.020
.020
.020
.020
.020
.0AZ
OG M
alar
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f (H
RPII)
/pf (
LDH
)/ (P
AN-L
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ntig
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Dete
ctio
n De
vice
cM
FV-1
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AZOG
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C.15
.016
.013
.015
.014
.0 (1
4)12
.020
.020
.0
Core
Mal
aria
Pan
Pf
MAL
-190
024
Core
Dia
gnos
tics
Ltd.
20.0
20.0
20.0
20.0
20.0
20.0
20.0
20.0
EzDx
™ M
alar
ia P
an/P
f Rap
id T
est D
etec
tion
kit
RK M
AL 0
01Ad
vy C
hem
ical
(Aff
iliat
e of
Bha
rat S
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Vac
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18.0
18.0
17.0
20.0
20.0
20.0
20.0
20.0
Firs
tSig
n™ P
araV
iew
(Pan
+Pf)
2101
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
18.0
18.0
17.0
20.0
19.0
(19)
19.0
20.0
20.0
Hum
asis
Mal
aria
P.f/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is, C
o., L
td.
20.0
20.0
20.0
20.0
20.0
20.0
20.0
20.0
ICT
MAL
ARIA
COM
BOM
L02
ICT
INTE
RNAT
ION
AL18
.018
.017
.018
.018
.0 (1
8)18
.020
.020
.0IN
D ON
E ST
EP M
ALAR
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NTI
GEN
P.f/
Pan
TEST
535-
10IN
D Di
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s In
c.19
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.019
.019
.019
.0 (1
9)19
.020
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.0M
alar
ia P
f/ P
ANG
M00
4G
enom
ix M
olec
ular
Dia
gnos
tics
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td.
10.0
13.0
10.0
11.0
12.0
(12)
11.0
18.0
20.0
Mal
aria
pf (
HRP
II)/P
AN (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e1-
13-1
01-1
Uni
ted
Biot
ech,
Inc.
16
.015
.014
.016
.014
.0 (1
4)14
.020
.020
.0M
aler
isca
n® M
alar
ia P
.f/PA
N (P
v, Pm
, Po)
3 L
ine
Antig
en T
est
MAT
-PF/
PAN
-50
Bhat
Bio
-Tec
h In
dia
(Pte
.) Lt
d.19
.018
.018
.018
.017
.0 (1
7)17
.020
.020
.0M
eDiP
ro M
alar
ia A
g H
RP2/
pLDH
Com
boIR
-005
1KFo
rmos
a Bi
omed
ical
Tec
hnol
ogy
Corp
.18
.019
.017
.020
.018
.0 (1
8)18
.020
.020
.0N
anoS
ign
Mal
aria
pf/
pan
Ag 3
.0RM
AP10
Biol
and
Ltd.
20.0
20.0
20.0
20.0
20.0
20.0
20.0
20.0
OnSi
te P
f/Pa
n Ag
Rap
id T
est
R011
3CCT
K Bi
otec
h, In
c.14
.017
.013
.017
.016
.0 (1
6)16
.020
.020
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raH
IT -
Tot
al V
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ipst
ick)
55IC
203-
10Sp
an D
iagn
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s Lt
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.016
.016
.016
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6)15
.020
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raH
IT -
Tot
al V
er. 1
.0 (D
evic
e)55
IC20
4-10
Span
Dia
gnos
tics
Ltd.
19.0
19.0
19.0
20.0
18.0
(18)
18.0
20.0
20.0
Para
scre
en®
- Ra
pid
test
for M
alar
ia P
an/P
f50
3100
25Ze
phyr
Bio
med
ical
s20
.020
.020
.020
.020
.020
.019
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9)20
.0SD
BIO
LIN
E M
alar
ia A
g Pf
/ Pan
05FK
66St
anda
rd D
iagn
ostic
s In
c.
19.0
19.0
19.0
18.0
(19)
19.0
(19)
18.0
(19)
20.0
19.0
(19)
Pf a
nd P
vCa
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOG
0161
Acce
ss B
io, I
nc.
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20.0
20.0
17.0
20.0
17.0
20.0
20.0
Care
Star
t™ M
alar
ia H
RP2/
pLDH
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VOM
) COM
BOG
0171
Acce
ss B
io, I
nc.
20.0
19.0
19.0
20.0
20.0
20.0
20.0
20.0
Falc
iVax
™ -
Rap
id te
st fo
r Mal
aria
Pv/
Pf
5030
0025
Zeph
yr B
iom
edic
als
20.0
20.0
20.0
19.0
20.0
19.0
20.0
19.0
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 83
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
P. f
alci
paru
m s
ampl
es (n
=20)
Tota
l pos
itive
res
ults
ret
urne
d
200
para
sites
/μl
2000
par
asite
s/μl
Lot
1Lo
t 2
Lot
1Lo
t 2
Test
1Te
st 2
No.
pos
itive
ag
reem
ents
b (m
ax=2
0)Te
st 1
Test
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o. p
ositi
ve
agre
emen
tsb
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Test
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HiS
ens
Mal
aria
Ag
P.f/
P.v
Com
bo C
ard
HR3
123
HBI
Co.
, Ltd
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.020
.019
.020
.020
.020
.020
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iSen
s M
alar
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f/VO
M C
ombo
Car
dH
R332
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BI C
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20.0
20.0
20.0
20.0
20.0
20.0
20.0
Hum
asis
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aria
P.f/
P.v
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5H
umas
is, C
o., L
td.
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18.0
17.0
20.0
19.0
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19.0
19.0
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20.0
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aria
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PvG
M00
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enom
ix M
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14.0
13.0
12.0
11.0
10.0
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20.0
Mal
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pf (
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pv
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Test
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20.0
20.0
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sor M
alar
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r, In
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edis
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e St
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est (
Cass
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edic
al (B
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g) C
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14.0
14.0
14.0
13.0
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20.0
19.0
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te P
f/Pv
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Rapi
d Te
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14.0
18.0
20.0
18.0
20.0
20.0
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Care
Mal
aria
HRP
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f/Pv
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BOG
0161
Acce
ss B
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20.0
20.0
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20.0
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20.0
20.0
Para
Care
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f/VO
M) C
OMBO
G01
71Ac
cess
Bio
Eth
iopi
a20
.019
.019
.020
.020
.020
.020
.020
.0RA
PID
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3® H
EMA
EXPR
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PF/
PV T
EST
MAL
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Diag
nost
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1.0
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9.0
0.0
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RAPI
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20.0
20.0
20.0
20.0
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20.0
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NE
Mal
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20.0
19.0
20.0
19.0
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19.0
20.0
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Trus
ty™
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aria
Ant
igen
P.f.
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test
A03-
12-3
22Ar
tron
Lab
orat
orie
s In
c.18
.017
.017
.019
.019
.0 (1
9)18
.019
.020
.0Pa
n on
lyAZ
OG h
CG M
alar
ia D
etec
tion
Test
Dev
ice
MPT
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AZOG
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C.18
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.017
.017
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.0 (1
1)11
.020
.020
.0
Pf, P
lasm
odiu
m fa
lcip
arum
P
v, Pl
asm
odiu
m v
ivax
p
an, P
lasm
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m sp
ecie
sa
Resu
lts a
re b
ased
on
the
first
read
ers
inte
rpre
tatio
n ac
cord
ing
to m
anuf
actu
rers
inst
ruct
ions
.b
Num
ber o
f sam
ples
that
retu
rned
a p
ositi
ve re
sult
for b
oth
test
s. W
here
one
test
was
inva
lid a
nd th
e ot
her p
ositi
ve, p
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ve a
gree
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t was
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rded
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Posi
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lts p
rese
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e ta
ble
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ve p
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st li
ne (e
ither
pf-
HRP
2 or
pf-
pLDH
).
Tabl
e A
3.1
(con
tinue
d)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)84
Tabl
e A
3.2:
Dis
trib
utio
n of
tes
t ba
nd in
tens
ity
(0-4
) sc
ores
aga
inst
Pha
se 1
P. f
alci
paru
m c
ultu
red
para
site
s at
low
(20
0) a
nd h
igh
(200
0) p
aras
ite
dens
ities
(pa
rasi
tes/
µl)
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
200
para
sites
/μl
2000
par
asite
s/μl
200
para
sites
/μl
2000
par
asite
s/μl
Perc
enta
ge d
istrib
utio
n of
Pf
te
st b
and
inte
nsity
b (n
=80)
Perc
enta
ge d
istrib
utio
n of
Pf
te
st b
and
inte
nsity
b (n
=40)
Perc
enta
ge d
istrib
utio
n of
Pan
te
st b
and
inte
nsity
b (n
=80)
Perc
enta
ge d
istrib
utio
n of
Pan
te
st b
and
inte
nsity
b (n
=40)
0a1
23
40a
12
34
0a1
23
40a
12
34
Pf o
nly
ABON
™ M
alar
ia P
.f. R
apid
Tes
t Dev
ice
(Who
le B
lood
)IM
A-40
2AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td61
.337
.51.
30.
00.
02.
537
.542
.517
.50.
0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
ABI
OCRE
DIT
Mal
aria
pf(H
RP II
)H
R010
0Ra
piG
en In
c.0.
01.
336
.348
.813
.80.
00.
00.
022
.577
.5N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AFi
rstS
ign™
Mal
aria
Pf
2100
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
0.0
21.3
25.0
47.5
6.3
0.0
0.0
0.0
22.5
77.5
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
ICT
MAL
ARIA
P.F.
ML0
4IC
T IN
TERN
ATIO
NAL
86.3
13.8
0.0
0.0
0.0
15.0
37.5
32.5
15.0
0.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN P
.f 53
5-11
IND
Diag
nost
ics
Inc.
26.3
61.3
11.3
1.3
0.0
0.0
15.0
27.5
22.5
35.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
eris
can
® M
alar
ia P
.f An
tigen
Tes
tM
AT-P
F-50
Bhat
Bio
-Tec
h In
dia
(Pte
.) Lt
d.10
.038
.842
.58.
80.
00.
02.
517
.542
.537
.5N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AOn
e St
ep M
alar
ia P
.F T
est (
Cass
ette
)52
2352
Blue
Cro
ss B
io-M
edica
l (Be
ijing
) Co.
, Ltd
.0.
015
.020
.045
.020
.00.
00.
02.
57.
590
.0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
APa
rach
eck®
Pf-
Rapi
d Te
st f
or P
. fal
cipa
rum
Mal
aria
De
vice
(Ver
.3)
3030
1025
Orch
id B
iom
edic
al S
yste
ms
0.0
15.0
25.0
47.5
12.5
0.0
0.0
0.0
17.5
82.5
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Para
chec
k® P
f-Ra
pid
Test
for
P. f
alci
paru
m M
alar
ia
Dips
tick
(Ver
.3)
3030
2025
Orch
id B
iom
edic
al S
yste
ms
8.8
18.8
35.0
32.5
5.0
0.0
2.5
10.0
42.5
45.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Trus
ty™
Mal
aria
Ant
igen
P.f.
test
A03-
11-3
22Ar
tron
Lab
orat
orie
s In
c.11
.326
.337
.523
.81.
35.
00.
07.
530
.057
.5N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AW
ondf
o On
e St
ep M
alar
ia P
.f Te
st
W 3
7-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.7.
523
.835
.025
.08.
80.
00.
05.
020
.075
.0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
APf
and
Pan
ABON
™ P
lus M
alar
ia P
.f/Pa
n Ra
pid
Test
Dev
ice
(Who
le
Bloo
d)IM
A-T4
02AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td2.
541
.347
.57.
51.
30.
02.
525
.025
.047
.510
0.0
0.0
0.0
0.0
0.0
100.
00.
00.
00.
00.
0
AZOG
Mal
aria
pf (
HRP
II)/p
f (LD
H)/
(PAN
-LDH
) Ant
igen
De
tect
ion
Devi
cec
MFV
-124
FAZ
OG, I
NC.
25.0
32.5
36.3
6.3
0.0
0.0
5.0
17.5
35.0
42.5
80.0
20.0
0.0
0.0
0.0
57.5
35.0
7.5
0.0
0.0
AZOG
Mal
aria
pf (
HRP
II)/p
f (LD
H)/
(PAN
-LDH
) Ant
igen
De
tect
ion
Devi
ced
MFV
-124
FAZ
OG, I
NC.
78.8
21.3
0.0
0.0
0.0
50.0
42.5
7.5
0.0
0.0
80.0
20.0
0.0
0.0
0.0
57.5
35.0
7.5
0.0
0.0
Core
Mal
aria
Pan
Pf
MAL
-190
024
Core
Dia
gnos
tics
Ltd.
0.0
15.0
31.3
41.3
12.5
0.0
0.0
2.5
20.0
77.5
21.3
77.5
1.3
0.0
0.0
0.0
0.0
52.5
47.5
0.0
EzDx
™ M
alar
ia P
an/P
f Rap
id T
est D
etec
tion
kit
RK M
AL 0
01Ad
vy C
hem
ical
(Af
filia
te o
f Bh
arat
Se
rum
s &
Vac
cine
s Lt
d. )
5.0
35.0
46.3
13.8
0.0
0.0
0.0
12.5
32.5
55.0
93.8
6.3
0.0
0.0
0.0
0.0
82.5
17.5
0.0
0.0
Firs
tSig
n™ P
araV
iew
(Pan
+Pf)
2101
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
6.3
23.8
32.5
32.5
5.0
0.0
0.0
2.5
25.0
72.5
55.0
42.5
2.5
0.0
0.0
0.0
25.0
50.0
25.0
0.0
Hum
asis
Mal
aria
P.f/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is, C
o., L
td.
0.0
10.0
50.0
35.0
5.0
0.0
0.0
0.0
35.0
65.0
2.5
92.5
5.0
0.0
0.0
0.0
2.5
77.5
20.0
0.0
ICT
MAL
ARIA
COM
BOM
L02
ICT
INTE
RNAT
ION
AL10
.031
.341
.315
.02.
50.
00.
017
.537
.545
.076
.323
.80.
00.
00.
017
.577
.55.
00.
00.
0IN
D ON
E ST
EP M
ALAR
IA A
NTI
GEN
P.f/
Pan
TEST
535-
10IN
D Di
agno
stic
s In
c.5.
010
.028
.832
.523
.80.
02.
55.
012
.580
.067
.532
.50.
00.
00.
00.
025
.072
.52.
50.
0M
alar
ia P
f/ P
ANG
M00
4Ge
nom
ix M
olec
ular
Dia
gnos
tics P
vt.Lt
d.42
.547
.56.
33.
80.
05.
015
.022
.552
.55.
072
.527
.50.
00.
00.
057
.542
.50.
00.
00.
0M
alar
ia p
f (H
RP II
)/PAN
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
1-13
-101
-1U
nite
d Bi
otec
h, In
c.
23.8
28.8
33.8
11.3
2.5
0.0
0.0
22.5
22.5
55.0
90.0
10.0
0.0
0.0
0.0
60.0
40.0
0.0
0.0
0.0
Mal
eris
can®
Mal
aria
P.f/
PAN
(Pv
, Pm
, Po)
3 L
ine
Antig
en T
est
MAT
-PF/
PAN-
50Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
10.0
33.8
46.3
8.8
1.3
0.0
5.0
17.5
25.0
52.5
100.
00.
00.
00.
00.
010
0.0
0.0
0.0
0.0
0.0
MeD
iPro
Mal
aria
Ag
HRP
2/pL
DH C
ombo
IR-0
051K
Form
osa
Biom
edic
al Te
chno
logy
Cor
p.6.
343
.843
.85.
01.
30.
02.
525
.055
.017
.510
0.0
0.0
0.0
0.0
0.0
100.
00.
00.
00.
00.
0N
anoS
ign
Mal
aria
pf/
pan
Ag 3
.0RM
AP10
Biol
and
Ltd.
0.0
21.3
36.3
33.8
8.8
0.0
0.0
5.0
20.0
75.0
91.3
8.8
0.0
0.0
0.0
0.0
65.0
35.0
0.0
0.0
OnSi
te P
f/Pa
n Ag
Rap
id T
est
R011
3CCT
K Bi
otec
h, In
c.20
.036
.337
.56.
30.
00.
00.
032
.545
.022
.580
.020
.00.
00.
00.
010
.077
.512
.50.
00.
0Pa
raH
IT -
Tot
al V
er. 1
.0 (D
ipst
ick)
55IC
203-
10Sp
an D
iagn
ostic
s Lt
d.18
.837
.535
.06.
32.
50.
05.
020
.022
.552
.597
.51.
31.
30.
00.
010
.082
.57.
50.
00.
0Pa
raH
IT -
Tot
al V
er. 1
.0 (D
evic
e)55
IC20
4-10
Span
Dia
gnos
tics
Ltd.
5.0
40.0
25.0
26.3
3.8
0.0
2.5
7.5
27.5
62.5
96.3
3.8
0.0
0.0
0.0
0.0
82.5
17.5
0.0
0.0
Para
scre
en®
- Ra
pid
test
for M
alar
ia P
an/P
f50
3100
25Ze
phyr
Bio
med
ical
s0.
022
.530
.045
.02.
50.
00.
00.
030
.070
.08.
888
.82.
50.
00.
02.
50.
052
.545
.00.
0SD
BIO
LIN
E M
alar
ia A
g Pf
/ Pan
05FK
66St
anda
rd D
iagn
ostic
s In
c.
6.3
17.5
22.5
32.5
21.3
2.5
2.5
0.0
17.5
77.5
43.8
53.8
0.0
2.5
0.0
5.0
7.5
65.0
22.5
0.0
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 85
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
200
para
sites
/μl
2000
par
asite
s/μl
200
para
sites
/μl
2000
par
asite
s/μl
Perc
enta
ge d
istrib
utio
n of
Pf
te
st b
and
inte
nsity
b (n
=80)
Perc
enta
ge d
istrib
utio
n of
Pf
te
st b
and
inte
nsity
b (n
=40)
Perc
enta
ge d
istrib
utio
n of
Pan
te
st b
and
inte
nsity
b (n
=80)
Perc
enta
ge d
istrib
utio
n of
Pan
te
st b
and
inte
nsity
b (n
=40)
0a1
23
40a
12
34
0a1
23
40a
12
34
Pf a
nd P
vCa
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOG
0161
Acce
ss B
io, I
nc.
3.8
27.5
22.5
41.3
5.0
0.0
0.0
0.0
32.5
67.5
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) COM
BOG
0171
Acce
ss B
io, I
nc.
1.3
30.0
17.5
32.5
18.8
0.0
0.0
0.0
10.0
90.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Falc
iVax
™ -
Rap
id te
st fo
r Mal
aria
Pv/
Pf
5030
0025
Zeph
yr B
iom
edic
als
1.3
22.5
35.0
36.3
5.0
2.5
0.0
2.5
32.5
62.5
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
HiS
ens
Mal
aria
Ag
P.f/
P.v
Com
bo C
ard
HR3
123
HBI
Co.
, Ltd
.1.
330
.016
.336
.316
.30.
00.
00.
012
.587
.5N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AH
iSen
s M
alar
ia A
g P.
f/VO
M C
ombo
Car
dH
R332
3H
BI C
o., L
td.
0.0
32.5
17.5
35.0
15.0
0.0
0.0
0.0
12.5
87.5
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Hum
asis
Mal
aria
P.f/
P.v
Antig
en T
est
AMFV
-702
5H
umas
is, C
o., L
td.
5.0
32.5
41.3
16.3
5.0
0.0
0.0
7.5
27.5
65.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
aria
Pf/
PvG
M00
2Ge
nom
ix M
olec
ular
Dia
gnos
tics P
vt.Lt
d.40
.046
.312
.51.
30.
02.
515
.022
.557
.52.
5N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AM
alar
ia p
f (H
RP II
) / p
v (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e1-
13-1
01-3
Uni
ted
Biot
ech,
Inc.
22
.531
.333
.810
.02.
50.
00.
025
.025
.050
.0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Med
isen
sor M
alar
ia H
RP2/
pLDH
(Pf/
Pv) C
OMBO
M16
1M
edis
enso
r, In
c.3.
827
.522
.541
.35.
00.
00.
00.
032
.567
.5N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AM
edis
enso
r Mal
aria
HRP
2/pL
DH (P
f/VO
M) C
OMBO
M17
1M
edis
enso
r, In
c.1.
330
.017
.532
.518
.80.
00.
00.
010
.090
.0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AOn
e St
ep M
alar
ia P
.F/P
.V T
est (
Cass
ette
)52
3352
Blue
Cro
ss B
io-M
edica
l (Be
ijing
) Co.
, Ltd
.30
.045
.018
.86.
30.
02.
510
.017
.525
.045
.0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AOn
Site
Pf/
Pv A
g Ra
pid
Test
R011
2CCT
K Bi
otec
h, In
c.12
.536
.335
.015
.01.
30.
00.
025
.025
.050
.0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
APa
raCa
re M
alar
ia H
RP2/
pLDH
(Pf/
Pv) C
OMBO
G01
61Ac
cess
Bio
Eth
iopi
a3.
827
.522
.541
.35.
00.
00.
00.
032
.567
.5N
AN
AN
AN
AN
AN
AN
AN
AN
AN
APa
raCa
re M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) COM
BOG
0171
Acce
ss B
io E
thio
pia
1.3
30.0
17.5
32.5
18.8
0.0
0.0
0.0
10.0
90.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
RAPI
D 1-
2-3®
HEM
A EX
PRES
S® M
ALAR
IA P
F/PV
TES
TM
AL-P
FV-0
207
Hem
a Di
agno
stic
Sys
tem
s, LL
C91
.33.
85.
00.
00.
077
.512
.55.
02.
52.
5N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
RAPI
D 1-
2-3®
HEM
A CA
SSET
TE M
ALAR
IA P
F/PV
TES
TM
AL-P
FV-
CAS/
25(1
00)
Hem
a Di
agno
stic
Sys
tem
s, LL
C0.
026
.322
.547
.53.
80.
00.
02.
525
.072
.5N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
vc05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
2.5
18.8
22.5
32.5
23.8
0.0
0.0
0.0
22.5
77.5
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
vd05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
70.0
30.0
0.0
0.0
0.0
0.0
15.0
77.5
7.5
0.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Trus
ty™
Mal
aria
Ant
igen
P.f.
/p.v.
test
A03-
12-3
22Ar
tron
Lab
orat
orie
s In
c.8.
831
.345
.013
.81.
32.
50.
012
.527
.557
.5N
AN
AN
AN
AN
AN
AN
AN
AN
AN
APa
n on
lyAZ
OG h
CG M
alar
ia D
etec
tion
Test
Dev
ice
MPT
-124
AZOG
, IN
C.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A18
.835
.031
.313
.81.
30.
07.
512
.535
.045
.0
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
a De
note
s no
ban
d vi
sibl
e b
Calc
ulat
ions
incl
ude
inva
lid te
sts
c Re
sults
pre
sent
ed i
n th
e ta
ble
are
base
d on
ban
d in
tens
ity o
f a p
f-H
RP2
line
d Re
sults
pre
sent
ed i
n th
e ta
ble
are
base
d on
ban
d in
tens
ity o
f a p
f-pL
DH li
ne
Tabl
e A
3.2
(con
tinue
d)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)86
anne
x 4:
pha
se 2
res
ults
Tabl
eA4.
1: L
ot v
aria
bilit
y in
pos
itive
res
ults
aga
inst
Pha
se 2
wild
typ
e P.
fal
cipa
rum
and
P. v
ivax
sam
ples
at
low
(20
0) a
nd h
igh
(200
0) p
aras
ite
dens
ity
(par
asit
es/µ
l)
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
P. f
alci
paru
m s
ampl
es (n
=98)
P. v
ivax
sam
ples
(n=3
4)To
tal p
ositi
ve r
esul
tsa
retu
rned
Tota
l pos
itive
res
ults
a re
turn
ed
200
para
sites
/μl
2000
b pa
rasit
es/μ
l20
0 pa
rasit
es/μ
l20
00b
para
sites
/μl
Lot
1Lo
t 2
Lot
1Lo
t 2
Lot
1Lo
t 2
Lot
1Lo
t 2
Test
1Te
st 2
No.
pos
itive
ag
reem
ents
c (m
ax=1
00)
Test
1Te
st 2
No.
pos
itive
ag
reem
ents
c (m
ax=1
00)
Test
1Te
st 2
Test
1Te
st 2
No.
pos
itive
ag
reem
ents
c (m
ax=3
5)Te
st 1
Test
2N
o. p
ositi
ve
agre
emen
tsc
(max
=35)
Test
1Te
st 2
Pf o
nly
ABON
™ M
alar
ia P.
f. Ra
pid
Test
Dev
ice (W
hole
Blo
od)
IMA-
402
ABO
N B
ioph
arm
(H
angz
hou)
Co
. Ltd
48.0
52.0
41.0
53.0
53.0
45.0
97.0
98.0
NA
NA
NA
NA
NA
NA
NA
NA
BIOC
REDI
T M
alar
ia p
f(HRP
II)
HR0
100
Rapi
Gen
Inc.
97.0
(97)
97.0
(97)
96.0
(96)
98.0
97.0
97.0
97.0
(97)
97.0
(97)
NA
NA
NA
NA
NA
NA
NA
NA
Firs
tSig
n™ M
alar
ia P
f21
00CB
-25
Uni
med
Inte
rnat
iona
l Inc
.96
.095
.094
.097
.095
.095
.098
.098
.0N
AN
AN
AN
AN
AN
AN
AN
AIN
D ON
E ST
EP M
ALAR
IA A
NTI
GEN
P.f
535-
11IN
D Di
agno
stic
s In
c.79
.069
.066
.078
.079
.070
.097
.0 (9
7)97
.0N
AN
AN
AN
AN
AN
AN
AN
AM
aler
isca
n ®
Mal
aria
P.f
Antig
en T
est
MAT
-PF-
50Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
92.0
92.0
89.0
95.0
90.0
89.0
96.0
98.0
NA
NA
NA
NA
NA
NA
NA
NA
One
Step
Mal
aria
P.F
Tes
t (Ca
sset
te)
5223
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co
., Lt
d.96
.094
.093
.098
.097
.097
.097
.098
.0N
AN
AN
AN
AN
AN
AN
AN
A
Para
chec
k® P
f-Ra
pid
Test
for P
. falci
paru
m M
alar
ia
Devi
ce (V
er.3
)30
3010
25Or
chid
Bio
med
ical
Sys
tem
s 97
.098
.097
.096
.097
.095
.098
.096
.0N
AN
AN
AN
AN
AN
AN
AN
A
Para
chec
k® P
f-Ra
pid
Test
for P
. falci
paru
m M
alar
ia
Dips
tick
(Ver
.3)
3030
2025
Orch
id B
iom
edic
al S
yste
ms
89.0
92.0
87.0
86.0
85.0
76.0
97.0
98.0
NA
NA
NA
NA
NA
NA
NA
NA
Trus
ty™
Mal
aria
Ant
igen
P.f.
test
A03-
11-3
22Ar
tron
Lab
orat
orie
s In
c.90
.089
.0 (9
7)88
.0 (9
7)93
.090
.090
.098
.098
.0N
AN
AN
AN
AN
AN
AN
AN
A
Won
dfo
One
Step
Mal
aria
P.f
Test
W
37-
CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
94.0
91.0
91.0
91.0
92.0
90.0
97.0
98.0
NA
NA
NA
NA
NA
NA
NA
NA
Pf a
nd P
anAB
ON™
Plu
s M
alar
ia P
.f/Pa
n Ra
pid
Test
Dev
ice
(Who
le B
lood
)IM
A-T4
02AB
ON
Bio
phar
m (
Han
gzho
u)
Co. L
td90
.088
.086
.090
.092
.087
.098
.098
.05.
02.
02.
04.
02.
02.
034
.033
.0
AZO
G M
alar
ia p
f (H
RPII)
/pf
(LD
H)/
(PAN
-LD
H)
Antig
en D
etec
tion
Devi
ced
MFV
-124
FAZ
OG, I
NC.
76.0
73.0
71.0
74.0
74.0
(96)
69.0
(96)
97.0
97.0
0.0
2.0
0.0
0.0
1.0
0.0
32.0
31.0
Core
Mal
aria
Pan
Pf
MAL
-190
024
Core
Dia
gnos
tics
Ltd.
97.0
98.0
97.0
98.0
97.0
97.0
98.0
98.0
17.0
20.0
10.0
27.0
26.0
22.0
15.0
24.0
EzDx
™ M
alar
ia P
an/P
f Rap
id T
est D
etec
tion
kit
RK M
AL 0
01Ad
vy C
hem
ical (
Affil
iate
of B
hara
t Se
rum
s &
Vac
cine
s Lt
d. )
82.0
(97)
80.0
77.0
(97)
89.0
87.0
85.0
97.0
98.0
12.0
12.0
8.0
7.0
10.0
6.0
34.0
32.0
Firs
tSig
n™ P
araV
iew
(Pan
+Pf)
2101
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
90.0
92.0
89.0
91.0
92.0
89.0
98.0
98.0
30.0
31.0
27.0
30.0
27.0
26.0
34.0
34.0
Hum
asis
Mal
aria
P.f/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is, C
o., L
td.
98.0
98.0
98.0
98.0
98.0
98.0
98.0
98.0
0.0
0.0
0.0
1.0
0.0
0.0
0.0
1.0
ICT
MAL
ARIA
COM
BOM
L02
ICT
INTE
RNAT
ION
AL89
.087
.086
.080
.082
.076
.096
.0 (9
7)97
.017
.010
.07.
05.
05.
04.
032
.032
.0IN
D ON
E ST
EP M
ALAR
IA A
NTI
GEN
P.f/
Pan
TEST
535-
10IN
D Di
agno
stic
s In
c.94
.096
.093
.097
.096
.096
.098
.098
.030
.029
.027
.031
.029
.027
.030
.033
.0
Mal
aria
Pf/
PAN
GM
004
Gen
omix
Mol
ecul
ar D
iagn
ostic
s Pv
t.Ltd
.54
.048
.043
.056
.053
.049
.094
.094
.05.
07.
03.
04.
08.
02.
033
.034
.0
Mal
aria
pf (
HRP
II)/P
AN (p
LDH)
Ant
igen
Det
ectio
n Te
st D
evic
e1-
13-1
01-1
Uni
ted
Biot
ech,
Inc.
72
.072
.067
.076
.070
.069
.098
.098
.03.
03.
02.
04.
02.
0 (3
3)1.
0 (3
3)31
.031
.0
Mal
eris
can®
Mal
aria
P.f/
PAN
(Pv,
Pm, P
o) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PA
N-
50Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
91.0
94.0
91.0
95.0
(97)
88.0
86.0
(97)
98.0
98.0
1.0
2.0
1.0
0.0
1.0
0.0
30.0
29.0
MeD
iPro
Mal
aria
Ag
HRP
2/pL
DH C
ombo
IR-0
051K
Form
osa
Biom
edic
al Te
chno
logy
Co
rp.
82.0
85.0
78.0
82.0
85.0
(97)
77.0
(97)
97.0
98.0
1.0
1.0
1.0
1.0
1.0
1.0
0.0
0.0
Nan
oSig
n M
alar
ia p
f/pa
n Ag
3.0
RMAP
10Bi
olan
d Lt
d.95
.096
.095
.096
.093
.092
.098
.098
.034
.034
.034
.034
.033
.033
.034
.034
.0On
Site
Pf/
Pan
Ag R
apid
Tes
tR0
113C
CTK
Biot
ech,
Inc.
80.0
79.0
75.0
84.0
85.0
82.0
97.0
97.0
33.0
33.0
32.0
31.0
34.0
31.0
33.0
34.0
Para
HIT
- T
otal
Ver
. 1.0
(Dip
stic
k)55
IC20
3-10
Span
Dia
gnos
tics
Ltd.
83.0
82.0
79.0
86.0
85.0
82.0
98.0
98.0
29.0
26.0
24.0
30.0
32.0
28.0
34.0
32.0
Para
HIT
- T
otal
Ver
. 1.0
(Dev
ice)
55IC
204-
10Sp
an D
iagn
ostic
s Lt
d.89
.090
.087
.094
.089
.089
.097
.098
.034
.030
.030
.032
.034
.032
.034
.030
.0 (3
3)Pa
rasc
reen
® -
Rapi
d te
st fo
r Mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
edic
als
97.0
(97)
98.0
97.0
(97)
98.0
97.0
97.0
98.0
98.0
18.0
22.0
14.0
25.0
30.0
22.0
18.0
16.0
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
an05
FK66
Stan
dard
Dia
gnos
tics
Inc.
94
.093
.092
.092
.0 (9
6)92
.0 (9
3)86
.0 (9
1)98
.097
.0 (9
7)34
.034
.034
.031
.0 (3
1)29
.0 (3
1)26
.0 (2
8)34
.033
.0 (3
3)
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 87
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
P. f
alci
paru
m s
ampl
es (n
=98)
P. v
ivax
sam
ples
(n=3
4)To
tal p
ositi
ve r
esul
tsa
retu
rned
Tota
l pos
itive
res
ults
a re
turn
ed
200
para
sites
/μl
2000
b pa
rasit
es/μ
l20
0 pa
rasit
es/μ
l20
00b
para
sites
/μl
Lot
1Lo
t 2
Lot
1Lo
t 2
Lot
1Lo
t 2
Lot
1Lo
t 2
Test
1Te
st 2
No.
pos
itive
ag
reem
ents
c (m
ax=1
00)
Test
1Te
st 2
No.
pos
itive
ag
reem
ents
c (m
ax=1
00)
Test
1Te
st 2
Test
1Te
st 2
No.
pos
itive
ag
reem
ents
c (m
ax=3
5)Te
st 1
Test
2N
o. p
ositi
ve
agre
emen
tsc
(max
=35)
Test
1Te
st 2
Pf a
nd P
vCa
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOG
0161
Acce
ss B
io, I
nc.
93.0
93.0
91.0
95.0
92.0
91.0
98.0
98.0
33.0
34.0
33.0
34.0
33.0
33.0
34.0
34.0
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/V
OM) C
OMBO
G01
71Ac
cess
Bio
, Inc
.94
.091
.090
.096
.091
.091
.098
.098
.033
.034
.033
.033
.033
.032
.034
.034
.0Fa
lciV
ax™
- R
apid
test
for M
alar
ia P
v/Pf
50
3000
25Ze
phyr
Bio
med
ical
s98
.096
.096
.097
.097
.097
.098
.098
.034
.034
.034
.033
.031
.030
.034
.034
.0H
iSen
s M
alar
ia A
g P.
f/P.
v Co
mbo
Car
dH
R312
3H
BI C
o., L
td.
93.0
93.0
(97)
91.0
(97)
93.0
91.0
91.0
98.0
98.0
34.0
33.0
33.0
32.0
29.0
28.0
34.0
32.0
HiS
ens
Mal
aria
Ag
P.f/
VOM
Com
bo C
ard
HR3
323
HBI
Co.
, Ltd
.93
.095
.093
.091
.091
.089
.098
.098
.032
.033
.032
.032
.029
.028
.034
.031
.0H
umas
is M
alar
ia P
.f/P.
v An
tigen
Tes
tAM
FV-7
025
Hum
asis,
Co.
, Ltd
.94
.093
.092
.098
.095
.095
.098
.098
.034
.034
.034
.034
.034
.034
.034
.034
.0
Mal
aria
Pf/
PvG
M00
2G
enom
ix M
olec
ular
Dia
gnos
tics
Pvt.L
td.
59.0
51.0
47.0
57.0
50.0
48.0
94.0
94.0
0.0
0.0
0.0
2.0
4.0
1.0
7.0
9.0
Mal
aria
pf (
HRP
II) /
pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
1-13
-101
-3U
nite
d Bi
otec
h, In
c.
75.0
74.0
70.0
71.0
73.0
66.0
92.0
(97)
96.0
2.0
0.0
0.0
1.0
2.0
(33)
0.0
(33)
17.0
16.0
Med
isen
sor M
alar
ia H
RP2/
pLDH
(Pf/
Pv) C
OMBO
M16
1M
edis
enso
r, In
c.93
.093
.091
.095
.092
.091
.098
.098
.033
.034
.033
.034
.033
.033
.034
.034
.0M
edise
nsor
Mal
aria
HRP
2/pL
DH (P
f/VOM
) COM
BOM
171
Med
isen
sor,
Inc.
94.0
91.0
90.0
96.0
91.0
91.0
98.0
98.0
33.0
34.0
33.0
33.0
33.0
32.0
34.0
34.0
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co
., Lt
d.65
.070
.061
.064
.063
.058
.095
.095
.01.
02.
01.
01.
03.
01.
032
.033
.0
OnSi
te P
f/Pv
Ag
Rapi
d Te
stR0
112C
CTK
Biot
ech,
Inc.
88.0
82.0
81.0
85.0
89.0
83.0
98.0
98.0
34.0
34.0
34.0
34.0
34.0
34.0
34.0
34.0
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOG
0161
Acce
ss B
io E
thio
pia
93.0
93.0
91.0
95.0
92.0
91.0
98.0
98.0
33.0
34.0
33.0
34.0
33.0
33.0
34.0
34.0
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/VO
M) C
OMBO
G01
71Ac
cess
Bio
Eth
iopi
a94
.091
.090
.096
.091
.091
.098
.098
.033
.034
.033
.033
.033
.032
.034
.034
.0RA
PID
1-2
-3®
HEM
A CA
SSET
TE M
ALAR
IA P
F/PV
TES
TM
AL
-P
FV
-CA
S/25
(100
)H
ema
Diag
nost
ic S
yste
ms,
LLC
95.0
96.0
95.0
94.0
93.0
91.0
98.0
98.0
32.0
30.0
28.0
33.0
32.0
31.0
34.0
34.0
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
vd05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
98.0
97.0
97.0
95.0
98.0
95.0
98.0
98.0
34.0
34.0
34.0
33.0
34.0
33.0
34.0
34.0
Trus
ty™
Mal
aria
Ant
igen
P.f.
/p.v.
test
A03-
12-3
22Ar
tron
Lab
orat
orie
s In
c.91
.088
.087
.091
.091
.089
.096
.0 (9
7)97
.0 (9
7)18
.0 (3
3)17
.014
.0 (3
3)24
.027
.022
.033
.0 (3
3)34
.0Pa
n on
lyAZ
OG h
CG M
alar
ia D
etec
tion
Test
Dev
ice
MPT
-124
AZOG
, IN
C.78
.072
.070
.075
.069
.066
.097
.098
.03.
01.
01.
04.
01.
00.
024
.024
.0
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
a Re
sults
are
bas
ed o
n th
e fir
st re
ader
s in
terp
reta
tion
acco
rdin
g to
man
ufac
ture
rs in
stru
ctio
ns.
b 5
(5%
) of t
he 9
8 P.
falc
ipar
um d
ilutio
n sa
mpl
es s
ets
wer
e 20
0 an
d 50
00 p
aras
ites/
µl a
nd 1
(3%
) of t
he 3
4 P.
viv
ax d
ilutio
n sa
mpl
e se
ts w
ere
200
and
5000
par
asite
s/µl
c
Num
ber o
f sam
ples
that
retu
rned
a p
ositi
ve re
sult
for b
oth
test
s. W
here
one
test
was
inva
lid a
nd th
e ot
her p
ositi
ve, p
ositi
ve a
gree
men
t was
reco
rded
.d
Resu
lts p
rese
nted
in th
e ta
ble
are
base
d on
a p
ositi
ve p
f tes
t lin
e (e
ither
pf-
HRP
2 or
pf-
pLDH
).
Tabl
e A
4.1
(con
tinue
d)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)88
Tabl
e A
4.2:
Dis
trib
utio
n of
tes
t ba
nd in
tens
ity
(0-4
) sc
ores
aga
inst
Pha
se 2
wild
typ
e P.
fal
cipa
rum
sam
ples
at
low
(20
0) a
nd h
igh
(200
0) p
aras
ite
dens
ities
(pa
rasi
tes/
µl)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
200
para
sites
/μl
2000
b pa
rasit
es/μ
l20
0 pa
rasit
es/μ
l20
00b
para
sites
/μl
200
para
sites
/μl
2000
b pa
rasit
es/μ
lPe
rcen
tage
dist
ribut
ion
of P
f te
st b
and
inte
nsity
c (n
=392
)
Perc
enta
ge d
istrib
utio
n of
Pf
test
ban
d in
tens
ityc
(n=1
96)
Perc
enta
ge d
istrib
utio
n of
pa
n te
st b
and
inte
nsity
c (n
=392
)
Perc
enta
ge d
istrib
utio
n of
pa
n te
st b
and
inte
nsity
c (n
=196
)
Perc
enta
ge d
istrib
utio
n of
Pv
test
ban
d in
tens
ityc
(n=3
92)
Perc
enta
ge d
istrib
utio
n of
Pv
test
ban
d in
tens
ityc
(n=1
96)
0a1
23
40a
12
34
0a1
23
40a
12
34
0a1
23
40a
12
34
Pf o
nly
ABON
™ M
alar
ia P
.f. R
apid
Tes
t Dev
ice
(Who
le B
lood
)IM
A-40
2AB
ON B
ioph
arm
(H
angz
hou)
Co.
Ltd
47.5
34.4
17.6
0.5
0.0
0.5
12.2
43.9
34.7
8.7
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
BIOC
REDI
T M
alar
ia p
f(HRP
II)
HR0
100
Rapi
Gen
Inc.
0.8
4.3
32.7
38.0
24.2
0.5
0.5
5.1
9.2
84.7
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Firs
tSig
n™ M
alar
ia P
f21
00CB
-25
Unim
ed In
tern
atio
nal I
nc.
2.3
11.2
41.6
26.8
18.1
0.0
0.0
4.1
13.8
82.1
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN P
.f 53
5-11
IND
Diag
nost
ics
Inc.
22.2
40.8
28.3
7.9
0.8
1.0
4.6
12.2
30.1
52.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
eris
can
® M
alar
ia P
.f An
tigen
Tes
tM
AT-P
F-50
Bhat
Bio
-Tec
h In
dia
(Pte
.) Lt
d.5.
918
.449
.021
.75.
11.
01.
012
.230
.155
.6N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
One
Step
Mal
aria
P.F
Tes
t (Ca
sset
te)
5223
52Bl
ue C
ross
Bio
-Med
ical
(B
eijin
g) C
o., L
td.
1.8
7.9
28.1
35.0
27.3
0.5
0.0
1.5
10.2
87.8
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Para
chec
k® P
f-Ra
pid
Test
for
P. fa
lcip
arum
Mal
aria
Dev
ice
(Ver
.3)
3030
1025
Orch
id B
iom
edic
al
Syst
ems
1.0
5.6
31.9
33.2
28.3
1.0
0.0
2.0
7.7
89.3
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Para
chec
k® P
f-Ra
pid
Test
for
P. fa
lcip
arum
Mal
aria
Dip
stic
k (V
er.3
)30
3020
25Or
chid
Bio
med
ical
Sy
stem
s 10
.219
.437
.023
.510
.00.
51.
514
.321
.462
.2N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Trus
ty™
Mal
aria
Ant
igen
P.f.
test
A03-
11-3
22Ar
tron
Lab
orat
orie
s In
c.7.
718
.443
.421
.98.
70.
02.
05.
620
.471
.9N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Won
dfo
One
Step
Mal
aria
P.f
Test
W
37-
CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
6.1
12.2
39.8
26.3
15.6
0.5
0.5
4.1
12.8
82.1
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Pf a
nd P
anAB
ON™
Plu
s M
alar
ia P
.f/Pa
n Ra
pid
Test
Dev
ice
(Who
le B
lood
)IM
A-T4
02AB
ON B
ioph
arm
(H
angz
hou)
Co.
Ltd
8.2
24.2
44.6
17.9
5.1
0.0
1.5
10.7
32.7
55.1
96.9
1.0
2.0
0.0
0.0
76.0
19.4
4.6
0.0
0.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
AZO
G M
alar
ia p
f (H
RPII)
/pf
(LD
H)/
(PAN
-LDH
) Ant
igen
Det
ectio
n De
vice
dM
FV-1
24F
AZOG
, IN
C.24
.532
.128
.612
.52.
31.
03.
114
.335
.745
.998
.51.
50.
00.
00.
066
.319
.913
.80.
00.
0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
AZO
G M
alar
ia p
f (H
RPII)
/pf
(LD
H)/
(PAN
-LDH
) Ant
igen
Det
ectio
n De
vice
eM
FV-1
24F
AZOG
, IN
C.90
.87.
12.
00.
00.
050
.528
.620
.90.
00.
098
.51.
50.
00.
00.
066
.319
.913
.80.
00.
0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Core
Mal
aria
Pan
Pf
MAL
-190
024
Core
Dia
gnos
tics
Ltd.
0.5
6.9
44.6
33.9
14.0
0.0
0.0
3.6
19.9
76.5
40.8
39.8
18.6
0.8
0.0
2.0
4.1
49.0
37.8
7.1
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
EzDx
™ M
alar
ia P
an/P
f Rap
id T
est
Dete
ctio
n ki
tRK
MAL
001
Advy
Che
mic
al (A
ffili
ate
of B
hara
t Ser
ums
&
Vacc
ines
Ltd
.)13
.822
.239
.520
.93.
60.
53.
19.
224
.562
.885
.714
.30.
00.
00.
010
.237
.840
.311
.70.
0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Firs
tSig
n™ P
araV
iew
(Pan
+Pf)
2101
CB-2
5Un
imed
Inte
rnat
iona
l Inc
.6.
916
.341
.125
.010
.70.
00.
06.
617
.975
.560
.234
.25.
60.
00.
03.
111
.751
.528
.65.
1N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AH
umas
is M
alar
ia P
.f/Pa
n An
tigen
Tes
tAM
AL-7
025
Hum
asis,
Co.
, Ltd
.0.
05.
445
.236
.213
.30.
00.
04.
113
.382
.71.
574
.024
.20.
30.
01.
04.
147
.538
.39.
2N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AIC
T M
ALAR
IA C
OMBO
ML0
2IC
T IN
TERN
ATIO
NAL
13.8
16.1
38.3
23.5
8.4
1.5
1.0
10.2
15.3
71.9
80.1
15.6
3.1
1.0
0.3
24.5
38.8
28.1
8.7
0.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN
P.f/
Pan
TEST
535-
10IN
D Di
agno
stic
s In
c.2.
37.
130
.132
.727
.80.
00.
03.
68.
288
.362
.829
.18.
20.
00.
06.
117
.948
.025
.52.
6N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Mal
aria
Pf/
PAN
GM
004
Gen
omix
Mol
ecul
ar
Diag
nost
ics
Pvt.L
td.
46.2
19.9
26.3
6.4
1.3
4.1
4.6
27.6
45.4
18.4
94.6
4.6
0.8
0.0
0.0
52.6
31.6
15.8
0.0
0.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
aria
pf (
HRP
II)/P
AN (p
LDH)
Ant
igen
De
tect
ion
Test
Dev
ice
1-13
-101
-1U
nite
d Bi
otec
h, In
c.
26.0
25.8
31.4
13.8
3.1
0.0
6.1
15.3
32.7
45.9
96.7
3.3
0.0
0.0
0.0
54.6
29.6
14.8
1.0
0.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
eris
can®
Mal
aria
P.f/
PAN
(Pv,
Pm,
Po) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PA
N-5
0Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
5.9
15.3
51.3
21.9
5.6
0.0
0.5
9.7
28.1
61.7
99.2
0.5
0.3
0.0
0.0
58.7
31.1
10.2
0.0
0.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
MeD
iPro
Mal
aria
Ag
HRP2
/pLD
H Co
mbo
IR-0
051K
Form
osa
Biom
edic
al
Tech
nolo
gy C
orp.
14.8
33.9
43.6
7.4
0.3
0.5
3.6
23.5
54.6
17.9
97.2
0.0
1.8
1.0
0.0
91.8
5.1
1.0
2.0
0.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Nan
oSig
n M
alar
ia p
f/pa
n Ag
3.0
RMAP
10Bi
olan
d Lt
d.3.
17.
429
.940
.818
.90.
00.
03.
613
.383
.257
.433
.49.
20.
00.
02.
014
.850
.530
.12.
6N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AOn
Site
Pf/
Pan
Ag R
apid
Tes
tR0
113C
CTK
Biot
ech,
Inc.
16.3
30.6
38.3
13.5
1.3
1.0
3.1
17.9
34.7
43.4
90.3
9.7
0.0
0.0
0.0
13.8
50.0
34.7
1.5
0.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Para
HIT
- T
otal
Ver
. 1.0
(Dip
stic
k)55
IC20
3-10
Span
Dia
gnos
tics
Ltd.
14.3
22.2
40.3
18.6
4.6
0.0
2.6
9.7
21.4
66.3
78.6
15.8
5.4
0.3
0.0
7.7
26.5
46.4
15.3
4.1
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Para
HIT
- T
otal
Ver
. 1.0
(Dev
ice)
55IC
204-
10Sp
an D
iagn
ostic
s Lt
d.7.
714
.846
.721
.79.
20.
50.
58.
217
.473
.568
.624
.07.
40.
00.
02.
018
.461
.712
.85.
1N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 89
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
200
para
sites
/μl
2000
b pa
rasit
es/μ
l20
0 pa
rasit
es/μ
l20
00b
para
sites
/μl
200
para
sites
/μl
2000
b pa
rasit
es/μ
lPe
rcen
tage
dist
ribut
ion
of P
f te
st b
and
inte
nsity
c (n
=392
)
Perc
enta
ge d
istrib
utio
n of
Pf
test
ban
d in
tens
ityc
(n=1
96)
Perc
enta
ge d
istrib
utio
n of
pa
n te
st b
and
inte
nsity
c (n
=392
)
Perc
enta
ge d
istrib
utio
n of
pa
n te
st b
and
inte
nsity
c (n
=196
)
Perc
enta
ge d
istrib
utio
n of
Pv
test
ban
d in
tens
ityc
(n=3
92)
Perc
enta
ge d
istrib
utio
n of
Pv
test
ban
d in
tens
ityc
(n=1
96)
0a1
23
40a
12
34
0a1
23
40a
12
34
0a1
23
40a
12
34
Para
scre
en®
- Ra
pid
test
for M
alar
ia
Pan/
Pf50
3100
25Ze
phyr
Bio
med
ical
s0.
38.
740
.134
.216
.80.
00.
03.
69.
786
.738
.841
.819
.10.
30.
01.
05.
141
.839
.812
.2N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
an05
FK66
Stan
dard
Dia
gnos
tics I
nc.
5.1
6.4
24.5
28.1
36.0
0.5
0.0
2.0
6.6
90.8
38.5
37.0
21.4
2.8
0.3
1.5
3.1
31.6
35.2
28.6
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Pf a
nd P
vCa
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOG
0161
Acce
ss B
io, I
nc.
4.9
12.2
29.6
30.1
23.2
0.0
0.5
4.6
5.1
89.8
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
99.7
0.3
0.0
0.0
0.0
99.0
1.0
0.0
0.0
0.0
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) COM
BOG
0171
Acce
ss B
io, I
nc.
5.1
8.7
27.6
28.8
29.9
0.0
0.5
3.6
4.6
91.3
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
99.7
0.3
0.0
0.0
0.0
99.5
0.5
0.0
0.0
0.0
Falc
iVax
™ -
Rapi
d te
st fo
r Mal
aria
Pv/
Pf 5
0300
025
Zeph
yr B
iom
edic
als
1.0
8.2
40.3
30.6
19.9
0.0
0.0
4.6
7.7
87.8
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
99.2
0.0
0.8
0.0
0.0
100.
00.
00.
00.
00.
0H
iSen
s Mal
aria
Ag
P.f/
P.v
Com
bo C
ard
HR3
123
HBI
Co.
, Ltd
.5.
69.
232
.128
.624
.50.
00.
05.
612
.881
.6N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A99
.70.
00.
30.
00.
099
.50.
00.
50.
00.
0Hi
Sens
Mal
aria
Ag
P.f/V
OM C
ombo
Car
dH
R332
3H
BI C
o., L
td.
5.6
11.2
30.1
28.8
24.2
0.0
0.0
3.6
14.3
82.1
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
100.
00.
00.
00.
00.
099
.50.
00.
50.
00.
0H
umas
is M
alar
ia P
.f/P.
v An
tigen
Tes
tAM
FV-7
025
Hum
asis,
Co.
, Ltd
.3.
115
.340
.624
.716
.30.
00.
54.
113
.881
.6N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A99
.50.
50.
00.
00.
099
.50.
00.
50.
00.
0
Mal
aria
Pf/
PvG
M00
2G
enom
ix M
olec
ular
Di
agno
stic
s Pv
t.Ltd
.44
.620
.427
.65.
61.
84.
15.
623
.048
.518
.9N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A99
.20.
80.
00.
00.
099
.50.
50.
00.
00.
0
Mal
aria
pf (
HRP
II) /
pv
(pLD
H)
Antig
en D
etec
tion
Test
Dev
ice
1-13
-101
-3U
nite
d Bi
otec
h, In
c.
25.3
24.7
36.0
11.0
3.1
3.6
5.6
18.4
32.7
39.8
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
99.5
0.5
0.0
0.0
0.0
96.9
2.6
0.5
0.0
0.0
Med
isen
sor M
alar
ia H
RP2/
pLDH
(P
f/Pv
) COM
BOM
161
Med
isen
sor,
Inc.
4.9
12.2
29.6
30.1
23.2
0.0
0.5
4.6
5.1
89.8
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
99.7
0.3
0.0
0.0
0.0
99.0
1.0
0.0
0.0
0.0
Med
isen
sor M
alar
ia H
RP2/
pLDH
(P
f/VO
M) C
OMBO
M17
1M
edis
enso
r, In
c.5.
18.
727
.628
.829
.90.
00.
53.
64.
691
.3N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A99
.70.
30.
00.
00.
099
.50.
50.
00.
00.
0
One
Step
Mal
aria
P.F/
P.V
Test
(Cas
sett
e)52
3352
Blue
Cro
ss B
io-M
edic
al
(Bei
jing)
Co.
, Ltd
.33
.231
.426
.37.
71.
53.
13.
121
.428
.643
.9N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A10
0.0
0.0
0.0
0.0
0.0
100.
00.
00.
00.
00.
0
OnSi
te P
f/Pv
Ag
Rapi
d Te
stR0
112C
CTK
Biot
ech,
Inc.
12.2
25.8
43.6
16.8
1.5
0.0
3.6
10.7
33.2
52.6
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
98.5
1.3
0.3
0.0
0.0
98.0
1.0
1.0
0.0
0.0
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/Pv
) CO
MBO
G01
61Ac
cess
Bio
Eth
iopi
a4.
912
.229
.630
.123
.20.
00.
54.
65.
189
.8N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A99
.70.
30.
00.
00.
099
.01.
00.
00.
00.
0
Para
Care
Mal
aria
HRP
2/pL
DH
(Pf/
VOM
) COM
BOG
0171
Acce
ss B
io E
thio
pia
5.1
8.7
27.6
28.8
29.9
0.0
0.5
3.6
4.6
91.3
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
99.7
0.3
0.0
0.0
0.0
99.5
0.5
0.0
0.0
0.0
RAPI
D 1-
2-3®
HEM
A CA
SSET
TE
MAL
ARIA
PF/
PV T
EST
MAL
-PFV
-CA
S/25
(100
)H
ema
Diag
nost
ic
Syst
ems,
LLC
3.6
6.9
40.6
29.6
19.4
0.0
0.0
4.1
8.2
87.8
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
100.
00.
00.
00.
00.
010
0.0
0.0
0.0
0.0
0.0
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
vd05
FK10
0St
anda
rd D
iagn
ostic
s Inc
. 1.
07.
420
.230
.640
.80.
00.
01.
54.
693
.9N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A99
.70.
30.
00.
00.
099
.50.
00.
00.
00.
5SD
BIO
LIN
E M
alar
ia A
g Pf
/ Pf/
Pve
05FK
100
Stan
dard
Dia
gnos
tics I
nc.
54.9
30.1
14.5
0.5
0.0
2.0
4.6
39.3
35.7
18.4
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
99.7
0.3
0.0
0.0
0.0
99.5
0.0
0.0
0.0
0.5
Trus
ty™
Mal
aria
Ant
igen
P.f.
/p.v.
test
A03-
12-3
22Ar
tron
Lab
orat
orie
s In
c.7.
919
.148
.220
.44.
31.
03.
18.
728
.159
.2N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A86
.712
.21.
00.
00.
084
.215
.30.
50.
00.
0Pa
n on
lyAZ
OG h
CG M
alar
ia D
etec
tion
Test
Dev
iceM
PT-1
24AZ
OG, I
NC.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
25.0
28.8
35.7
9.2
1.3
0.5
3.1
15.8
35.2
45.4
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
a De
note
s no
vis
ible
ban
d b
5 (5
%) o
f the
98
P. fa
lcip
arum
dilu
tion
sam
ples
set
s w
ere
200
and
5000
par
asite
s/µl
an
d 1
(3%
) of t
he 3
4 P.
viv
ax d
ilutio
n sa
mpl
e se
ts w
ere
200
and
5000
par
asite
s/µl
c
Calc
ulat
ions
incl
ude
inva
lid te
sts
d Re
sults
pre
sent
ed i
n th
e ta
ble
are
base
d on
ban
d in
tens
ity o
f a p
f-H
RP2
line
e Re
sults
pre
sent
ed i
n th
e ta
ble
are
base
d on
ban
d in
tens
ity o
f a p
f-pL
DH li
ne
Tabl
e A
4.2
(con
tinue
d)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)90
Tabl
e A
4.3:
Dis
trib
utio
n of
Pan
/Pv
test
ban
d in
tens
ity
(0-4
) sc
ores
for
Pha
se 2
wild
typ
e P.
viv
ax s
ampl
es a
t lo
w (
200)
and
hig
h (2
000)
par
asit
e de
nsiti
es (
para
site
s/µl
)
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
200
para
sites
/μl
2000
b pa
rasit
es/μ
l20
0 pa
rasit
es/μ
l20
00b
para
sites
/μl
Perc
enta
ge d
istrib
utio
n of
Pan
te
st b
and
inte
nsity
e (n
=136
)Pe
rcen
tage
dist
ribut
ion
of P
an
test
ban
d in
tens
itye
(n=6
8)Pe
rcen
tage
dist
ribut
ion
of P
v
test
ban
d in
tens
itye
(n=1
36)
Perc
enta
ge d
istrib
utio
n of
Pv
te
st b
and
inte
nsity
e (n
=68)
0a1
23
40a
12
34
0a1
23
40a
12
34
Pf o
nly
ABON
™ M
alar
ia P
.f. R
apid
Tes
t Dev
ice
(Who
le B
lood
)IM
A-40
2AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
tdN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
ABI
OCRE
DIT
Mal
aria
pf(H
RP II
)H
R010
0Ra
piG
en In
c.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AFi
rstS
ign™
Mal
aria
Pf
2100
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN P
.f 53
5-11
IND
Diag
nost
ics
Inc.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
eris
can
® M
alar
ia P
.f An
tigen
Tes
tM
AT-P
F-50
Bhat
Bio
-Tec
h In
dia
(Pte
.) Lt
d.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AOn
e St
ep M
alar
ia P
.F T
est (
Cass
ette
)52
2352
Blue
Cro
ss B
io-M
edica
l (Be
ijing
) Co.
, Ltd
.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
APa
rach
eck®
Pf-
Rapi
d Te
st fo
r P. f
alci
paru
m M
alar
ia
Devi
ce (V
er.3
)30
3010
25Or
chid
Bio
med
ical
Sys
tem
s N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipa
rum
Mal
aria
Di
pstic
k (V
er.3
)30
3020
25Or
chid
Bio
med
ical
Sys
tem
s N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Trus
ty™
Mal
aria
Ant
igen
P.f.
test
A03-
11-3
22Ar
tron
Lab
orat
orie
s In
c.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AW
ondf
o On
e St
ep M
alar
ia P
.f Te
st
W 3
7-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
APf
and
Pan
ABON
™ P
lus
Mal
aria
P.f/
Pan
Rapi
d Te
st D
evic
e (W
hole
Blo
od)
IMA-
T402
ABON
Bio
phar
m (H
angz
hou)
Co.
Ltd
90.4
9.6
0.0
0.0
0.0
1.5
26.5
61.8
10.3
0.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
AZOG
Mal
aria
pf (
HRP
II)/p
f (LD
H)/
(PAN
-LDH
) An
tigen
Det
ectio
n De
vice
M
FV-1
24F
AZOG
, IN
C.95
.63.
70.
00.
70.
07.
433
.852
.94.
41.
5N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Core
Mal
aria
Pan
Pf
MAL
-190
024
Core
Dia
gnos
tics
Ltd.
0.0
16.9
73.5
8.1
1.5
0.0
0.0
1.5
32.4
66.2
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
EzDx
™ M
alar
ia P
an/P
f Rap
id T
est D
etec
tion
kit
RK M
AL 0
01Ad
vy C
hem
ical
(Af
filia
te o
f Bh
arat
Se
rum
s &
Vac
cine
s Lt
d. )
68.4
27.2
3.7
0.7
0.0
2.9
8.8
52.9
29.4
5.9
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Firs
tSig
n™ P
araV
iew
(Pan
+Pf)
2101
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
11.8
47.1
37.5
3.7
0.0
0.0
0.0
7.4
41.2
51.5
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Hum
asis
Mal
aria
P.f/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is, C
o., L
td.
0.0
11.0
79.4
9.6
0.0
0.0
0.0
1.5
41.2
57.4
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
ICT
MAL
ARIA
COM
BOM
L02
ICT
INTE
RNAT
ION
AL72
.121
.34.
42.
20.
05.
98.
863
.220
.61.
5N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AIN
D ON
E ST
EP M
ALAR
IA A
NTI
GEN
P.f/
Pan
TEST
535-
10IN
D Di
agno
stic
s In
c.10
.343
.444
.12.
20.
01.
51.
57.
450
.039
.7N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AM
alar
ia P
f/ P
ANG
M00
4Ge
nom
ix M
olec
ular
Dia
gnos
tics P
vt.Lt
d.81
.613
.25.
10.
00.
01.
539
.748
.57.
42.
9N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AM
alar
ia p
f (H
RP II
)/PAN
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
1-13
-101
-1U
nite
d Bi
otec
h, In
c.
91.2
8.8
0.0
0.0
0.0
8.8
27.9
58.8
4.4
0.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
eris
can®
Mal
aria
P.f/
PAN
(Pv,
Pm, P
o) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PA
N-50
Bhat
Bio
-Tec
h In
dia
(Pte
.) Lt
d.97
.12.
20.
70.
00.
011
.841
.245
.61.
50.
0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
MeD
iPro
Mal
aria
Ag
HRP
2/pL
DH C
ombo
IR-0
051K
Form
osa
Biom
edic
al Te
chno
logy
Cor
p.97
.10.
02.
90.
00.
010
0.0
0.0
0.0
0.0
0.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Nan
oSig
n M
alar
ia p
f/pa
n Ag
3.0
RMAP
10Bi
olan
d Lt
d.0.
740
.454
.44.
40.
00.
00.
01.
545
.652
.9N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AOn
Site
Pf/
Pan
Ag R
apid
Tes
tR0
113C
CTK
Biot
ech,
Inc.
3.7
53.7
40.4
2.2
0.0
0.0
0.0
13.2
70.6
16.2
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Para
HIT
- T
otal
Ver
. 1.0
(Dip
stic
k)55
IC20
3-10
Span
Dia
gnos
tics
Ltd.
14.0
45.6
39.0
1.5
0.0
2.9
1.5
5.9
35.3
54.4
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Para
HIT
- T
otal
Ver
. 1.0
(Dev
ice)
55IC
204-
10Sp
an D
iagn
ostic
s Lt
d.4.
440
.454
.40.
70.
02.
90.
010
.351
.535
.3N
AN
AN
AN
AN
AN
AN
AN
AN
AN
APa
rasc
reen
® -
Rapi
d te
st fo
r Mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
edic
als
0.0
14.7
75.0
10.3
0.0
0.0
0.0
0.0
13.2
86.8
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
an05
FK66
Stan
dard
Dia
gnos
tics
Inc.
5.
98.
159
.622
.14.
41.
50.
00.
05.
992
.7N
AN
AN
AN
AN
AN
AN
AN
AN
AN
APf
and
Pv
Care
Star
t™ M
alar
ia H
RP2/
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cess
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.N
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AN
AN
AN
AN
AN
AN
AN
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513
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00.
01.
522
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cess
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.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A2.
220
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00.
00.
01.
547
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lciV
ax™
- R
apid
test
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alar
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50
3000
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phyr
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AN
AN
AN
AN
AN
AN
AN
AN
A2.
930
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20.
00.
00.
01.
535
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ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 91
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
200
para
sites
/μl
2000
b pa
rasit
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0 pa
rasit
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l20
00b
para
sites
/μl
Perc
enta
ge d
istrib
utio
n of
Pan
te
st b
and
inte
nsity
e (n
=136
)Pe
rcen
tage
dist
ribut
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of P
an
test
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8)Pe
rcen
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ribut
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v
test
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(n=1
36)
Perc
enta
ge d
istrib
utio
n of
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te
st b
and
inte
nsity
e (n
=68)
0a1
23
40a
12
34
0a1
23
40a
12
34
HiS
ens
Mal
aria
Ag
P.f/
P.v
Com
bo C
ard
HR3
123
HBI
Co.
, Ltd
.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
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914
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72.
91.
57.
429
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iSen
s M
alar
ia A
g P.
f/VO
M C
ombo
Car
dH
R332
3H
BI C
o., L
td.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
7.4
19.9
68.4
4.4
0.0
4.4
0.0
11.8
57.4
26.5
Hum
asis
Mal
aria
P.f/
P.v
Antig
en T
est
AMFV
-702
5H
umas
is, C
o., L
td.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
0.0
4.4
72.8
21.3
1.5
0.0
0.0
0.0
39.7
60.3
Mal
aria
Pf/
PvG
M00
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nom
ix M
olec
ular
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vt.Lt
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AN
AN
AN
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AN
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AN
AN
AN
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90.
70.
076
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alar
ia p
f (H
RP II
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v (p
LDH
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igen
Det
ectio
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st D
evic
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ted
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ech,
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N
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AN
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AN
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AN
AN
AN
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70.
00.
00.
051
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0
Med
isen
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alar
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AN
AN
AN
AN
AN
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513
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00.
01.
522
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enso
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2/pL
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f/VO
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AN
AN
AN
AN
AN
AN
AN
AN
AN
A2.
220
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00.
00.
01.
547
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e St
ep M
alar
ia P
.F/P
.V T
est (
Cass
ette
)52
3352
Blue
Cro
ss B
io-M
edica
l (Be
ijing
) Co.
, Ltd
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AN
AN
AN
AN
AN
AN
AN
AN
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00.
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442
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pid
Test
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otec
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AN
AN
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467
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alar
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522
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alar
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ss B
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thio
pia
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
2.2
20.6
66.9
10.3
0.0
0.0
0.0
1.5
47.1
51.5
RAPI
D 1-
2-3®
HEM
A CA
SSET
TE M
ALAR
IA P
F/PV
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STM
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AN
AN
AN
AN
AN
AN
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641
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90.
00.
00.
07.
439
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IOLI
NE
Mal
aria
Ag
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f/ P
v05
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NA
NA
NA
NA
NA
NA
NA
NA
NA
0.7
9.6
64.7
16.9
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0.0
0.0
0.0
2.9
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Trus
ty™
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aria
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igen
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test
A03-
12-3
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tron
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s In
c.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A36
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70.
01.
54.
466
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n on
lyAZ
OG h
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alar
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tion
Test
Dev
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MPT
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AZOG
, IN
C.93
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11.
50.
00.
029
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.330
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40.
0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
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spec
ies
a De
note
s no
vis
ible
ban
d b
1 (3
%) o
f the
34
P. v
ivax
dilu
tion
sam
ple
sets
wer
e 20
0 an
d 50
00 p
aras
ites/
µl
c Pa
n te
st li
ned
P. v
ivax
test
line
e Ca
lcul
atio
ns in
clud
e in
valid
test
s
Tabl
e A
4.3
(con
tinue
d)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)92
Tabl
eA4.
4: P
anel
det
ectio
n sc
ore
of P
hase
2 w
ild t
ype
P. f
alci
paru
m a
t lo
w (
200)
and
hig
h (2
000)
par
asit
e de
nsiti
es (
para
site
s/µl
) by
con
tinen
t
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
200
para
sites
/μl
2000
b pa
rasit
es/μ
lPa
nel d
etec
tion
scor
ea b
y co
ntin
ent
of s
ampl
e or
igin
Pane
l det
ectio
n sc
orea
by
cont
inen
t of
sam
ple
orig
in
Afric
a
(n=5
7)As
ia
(n=2
4)So
uth
Amer
ica
(n=1
7)Af
rica
(n
=57)
Asia
(n
=24)
Sout
h Am
eric
a (n
=17)
Pf o
nly
ABON
™ M
alar
ia P
.f. R
apid
Tes
t Dev
ice
(Who
le B
lood
)IM
A-40
2AB
ON B
ioph
arm
(Han
gzho
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o. L
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OCRE
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aria
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RP II
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R010
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en In
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010
0.0
100.
0Fi
rstS
ign™
Mal
aria
Pf
2100
CB-2
5U
nim
ed In
tern
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nal I
nc.
80.7
100.
094
.110
0.0
100.
010
0.0
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN P
.f 53
5-11
IND
Diag
nost
ics
Inc.
91.2
100.
010
0.0
100.
010
0.0
100.
0M
aler
isca
n ®
Mal
aria
P.f
Antig
en T
est
MAT
-PF-
50Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
82.5
87.5
88.2
100.
010
0.0
100.
0On
e St
ep M
alar
ia P
.F T
est (
Cass
ette
)52
2352
Blue
Cro
ss B
io-M
edic
al (B
eijin
g) C
o., L
td.
43.9
62.5
52.9
94.7
100.
094
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rach
eck®
Pf-
Rapi
d Te
st fo
r P. f
alci
paru
m M
alar
ia D
evic
e (V
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25Or
chid
Bio
med
ical
Sys
tem
s 68
.475
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0.0
100.
094
.1Pa
rach
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Pf-
Rapi
d Te
st fo
r P. f
alci
paru
m M
alar
ia D
ipst
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Orch
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ms
77.2
100.
088
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0.0
100.
094
.1Tr
usty
™ M
alar
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ntig
en P
.f. te
stA0
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-322
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on L
abor
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Inc.
89.5
91.7
88.2
98.3
100.
010
0.0
Won
dfo
One
Step
Mal
aria
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Test
W
37-
CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
94.7
100.
010
0.0
100.
010
0.0
100.
0Pf
and
Pan
ABON
™ P
lus
Mal
aria
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Pan
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st D
evic
e (W
hole
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od)
IMA-
T402
ABON
Bio
phar
m (H
angz
hou)
Co.
Ltd
86.0
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88.2
100.
010
0.0
100.
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OG M
alar
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f (H
RPII)
/pf (
LDH
)/ (P
AN-L
DH) A
ntig
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ctio
n De
vice
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FV-1
24F
AZOG
, IN
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0.0
95.8
100.
010
0.0
100.
010
0.0
Core
Mal
aria
Pan
Pf
MAL
-190
024
Core
Dia
gnos
tics
Ltd.
66.7
91.7
88.2
98.3
100.
010
0.0
EzDx
™ M
alar
ia P
an/P
f Rap
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est D
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kit
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AL 0
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hem
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rat S
erum
s &
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96.5
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010
0.0
100.
010
0.0
100.
0
Firs
tSig
n™ P
araV
iew
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+Pf)
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nim
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tern
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nal I
nc.
84.2
100.
094
.110
0.0
100.
010
0.0
Hum
asis
Mal
aria
P.f/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is, C
o., L
td.
70.2
91.7
76.5
100.
010
0.0
94.1
ICT
MAL
ARIA
COM
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L02
ICT
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AL57
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535-
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D Di
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ANG
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ix M
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td.
40.4
37.5
47.1
93.0
100.
094
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alar
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f (H
RP II
)/PAN
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
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1-13
-101
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nite
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c.
40.4
37.5
41.2
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100.
094
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aler
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n® M
alar
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.f/PA
N (P
v, Pm
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est
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h In
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ro M
alar
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g H
RP2/
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a Bi
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100.
010
0.0
100.
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anoS
ign
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aria
pf/
pan
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AP10
Biol
and
Ltd.
93.0
100.
094
.198
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0.0
100.
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apid
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73.7
87.5
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010
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0.0
100.
010
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55IC
204-
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d.70
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010
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Para
scre
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pid
test
for M
alar
ia P
an/P
f50
3100
25Ze
phyr
Bio
med
ical
s91
.295
.894
.110
0.0
100.
010
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IOLI
NE
Mal
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84
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88.2
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010
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Pf a
nd P
vCa
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2/pL
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f/Pv
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ss B
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nc.
84.2
100.
094
.110
0.0
100.
010
0.0
Care
Star
t™ M
alar
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BOG
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ss B
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98.3
100.
010
0.0
100.
010
0.0
100.
0Fa
lciV
ax™
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apid
test
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alar
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v/Pf
50
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phyr
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0.0
100.
010
0.0
100.
010
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aria
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Com
bo C
ard
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123
HBI
Co.
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0.0
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010
0.0
100.
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iSen
s M
alar
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g P.
f/VO
M C
ombo
Car
dH
R332
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BI C
o., L
td.
87.7
100.
010
0.0
100.
010
0.0
100.
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umas
is M
alar
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tigen
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0.0
100.
0
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 93
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
200
para
sites
/μl
2000
b pa
rasit
es/μ
lPa
nel d
etec
tion
scor
ea b
y co
ntin
ent
of s
ampl
e or
igin
Pane
l det
ectio
n sc
orea
by
cont
inen
t of
sam
ple
orig
in
Afric
a
(n=5
7)As
ia
(n=2
4)So
uth
Amer
ica
(n=1
7)Af
rica
(n
=57)
Asia
(n
=24)
Sout
h Am
eric
a (n
=17)
Mal
aria
pf (
HRP
II) /
pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
1-13
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56.1
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100.
010
0.0
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edis
enso
r Mal
aria
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2/pL
DH (P
f/Pv
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161
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sor,
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094
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010
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sor M
alar
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171
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010
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010
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100.
0On
e St
ep M
alar
ia P
.F/P
.V T
est (
Cass
ette
)52
3352
Blue
Cro
ss B
io-M
edic
al (B
eijin
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o., L
td.
71.9
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100.
010
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te P
f/Pv
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ech,
Inc.
93.0
100.
010
0.0
96.5
100.
010
0.0
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Care
Mal
aria
HRP
2/pL
DH (P
f/Pv
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0161
Acce
ss B
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84.2
100.
094
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0.0
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010
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aria
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DH (P
f/VO
M) C
OMBO
G01
71Ac
cess
Bio
Eth
iopi
a98
.310
0.0
100.
010
0.0
100.
010
0.0
RAPI
D 1-
2-3®
HEM
A CA
SSET
TE M
ALAR
IA P
F/PV
TES
TM
AL-P
FV-C
AS/2
5(10
0)H
ema
Diag
nost
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yste
ms,
LLC
94.7
100.
010
0.0
100.
010
0.0
100.
0SD
BIO
LIN
E M
alar
ia A
g Pf
/ Pf/
Pvc
05FK
100
Stan
dard
Dia
gnos
tics
Inc.
86
.095
.888
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0.0
100.
010
0.0
Trus
ty™
Mal
aria
Ant
igen
P.f.
/p.v.
test
A03-
12-3
22Ar
tron
Lab
orat
orie
s In
c.56
.170
.870
.698
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94.1
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only
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hCG
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n Te
st D
evic
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PT-1
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OG, I
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64.7
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Afric
a -
Uni
ted
Repu
blic
of T
anza
nia,
Cen
tral
Afr
ican
Rep
ublic
, Mad
agas
car,
Nig
eria
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ya, E
thio
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Asia
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yanm
ar, T
he P
hilip
pine
s, Ca
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Sout
h Am
eric
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mod
ium
viv
ax
pan
, Pla
smod
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spec
ies
a A
sam
ple
is c
onsi
dere
d de
tect
ed o
nly
if al
l RDT
s fr
om b
oth
lots
read
by
the
first
tech
nici
an, a
t min
imum
spe
cifie
d re
adin
g tim
e, a
re p
ositi
veb
5 (5
%) o
f the
98
P. fa
lcip
arum
dilu
tion
sam
ples
set
s w
ere
200
and
5000
par
asite
s/µl
c
PDS
pres
ente
d in
the
tabl
e is
bas
ed o
n a
posi
tive
pf te
st li
ne (e
ither
pf-
HRP
2 or
pf-
pLDH
).
Tabl
e A
4.4
(con
tinue
d)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)94
Tabl
e A
4.5:
P. f
alci
paru
m t
est
line
fals
e-po
siti
ve r
ates
for
Pha
se 2
P. v
ivax
sam
ples
at
low
(20
0) a
nd h
igh
(200
0) p
aras
ite
dens
ities
(pa
rasi
tes/
µl)
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
P. v
ivax
sam
ples
(n=3
4)
200
para
sites
/μl
2000
a pa
rasit
es/μ
lFa
lse-
posi
tive
Pf in
fect
ionb
(%
)Fa
lse-
posi
tive
Pf in
fect
ionb
(%
)
Lot
1 (n
=68)
Lot
2 (n
=68)
Ove
rall
(n=1
36)
Lot
1 (n
=34)
Lot
2 (n
=34)
Ove
rall
(n=6
8)Pf
onl
yAB
ON™
Mal
aria
P.f.
Rap
id T
est D
evic
e (W
hole
Blo
od)
IMA-
402
ABON
Bio
phar
m (H
angz
hou)
Co.
Ltd
0.0
0.0
0.0
0.0
0.0
0.0
BIOC
REDI
T M
alar
ia p
f(HRP
II)
HR0
100
Rapi
Gen
Inc.
94.1
100.
097
.191
.210
0.0
95.6
Firs
tSig
n™ M
alar
ia P
f21
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-25
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med
Inte
rnat
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l Inc
.1.
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00.
72.
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D ON
E ST
EP M
ALAR
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NTI
GEN
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11IN
D Di
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stic
s In
c.4.
40.
02.
214
.714
.714
.7M
aler
isca
n ®
Mal
aria
P.f
Antig
en T
est
MAT
-PF-
50Bh
at B
io-T
ech
Indi
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te.)
Ltd.
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0.0
0.0
0.0
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Step
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aria
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Tes
t (Ca
sset
te)
5223
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co.
, Ltd
.0.
00.
00.
02.
90.
01.
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rach
eck®
Pf-
Rapi
d Te
st fo
r P. f
alci
paru
m M
alar
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evic
e (V
er.3
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25Or
chid
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med
ical
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tem
s 0.
00.
00.
00.
00.
00.
0Pa
rach
eck®
Pf-
Rapi
d Te
st fo
r P. f
alci
paru
m M
alar
ia D
ipst
ick
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3030
2025
Orch
id B
iom
edic
al S
yste
ms
0.0
0.0
0.0
0.0
0.0
0.0
Trus
ty™
Mal
aria
Ant
igen
P.f.
test
A03-
11-3
22Ar
tron
Lab
orat
orie
s In
c.4.
5 (6
7)4.
44.
4 (1
35)
2.9
2.9
2.9
Won
dfo
One
Step
Mal
aria
P.f
Test
W
37-
CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
0.0
0.0
0.0
0.0
0.0
0.0
Pf a
nd P
anAB
ON™
Plu
s M
alar
ia P
.f/Pa
n Ra
pid
Test
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le B
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OG M
alar
ia p
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AN-L
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ntig
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ctio
n De
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FV-1
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AZOG
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C.0.
00.
00.
00.
00.
00.
0
AZOG
Mal
aria
pf (
HRP
II)/p
f (LD
H)/
(PAN
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igen
De
tect
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ced
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OG, I
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5.9
5.2
0.0
0.0
0.0
Core
Mal
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Pf
MAL
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024
Core
Dia
gnos
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Ltd.
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22.1
33.8
55.9
29.4
42.7
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™ M
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iew
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ix M
olec
ular
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gnos
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0.0
0.0
0.0
Mal
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pf (
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AN (p
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igen
Det
ectio
n Te
st D
evic
e1-
13-1
01-1
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ted
Biot
ech,
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0.
00.
0 (6
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0 (1
35)
0.0
0.0
0.0
Mal
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can®
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2/pL
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ombo
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osa
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0On
Site
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apid
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0.0
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Para
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- T
otal
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. 1.0
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an05
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dard
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0 (6
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0 (1
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0.0
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nd P
vCa
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art™
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aria
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2/pL
DH (P
f/Pv
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Acce
ss B
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0.0
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t™ M
alar
ia H
RP2/
pLDH
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VOM
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BOG
0171
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ss B
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™ -
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st fo
r Mal
aria
Pv/
Pf
5030
0025
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yr B
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0.0
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ens
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P.v
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bo C
ard
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HBI
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, Ltd
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00.
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00.
00.
00.
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iSen
s M
alar
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f/VO
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o., L
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0.0
0.0
0.0
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ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 95
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
P. v
ivax
sam
ples
(n=3
4)
200
para
sites
/μl
2000
a pa
rasit
es/μ
lFa
lse-
posi
tive
Pf in
fect
ionb
(%
)Fa
lse-
posi
tive
Pf in
fect
ionb
(%
)
Lot
1 (n
=68)
Lot
2 (n
=68)
Ove
rall
(n=1
36)
Lot
1 (n
=34)
Lot
2 (n
=34)
Ove
rall
(n=6
8)H
umas
is M
alar
ia P
.f/P.
v An
tigen
Tes
tAM
FV-7
025
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asis,
Co.
, Ltd
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alar
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002
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ecul
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t.Ltd
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alar
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f (H
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v (p
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igen
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ech,
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Para
Care
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2/pL
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f/Pv
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Acce
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AZOG
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AN
AN
AN
AN
AN
A
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, Pla
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viv
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pan
, Pla
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ium
spec
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he 3
4 P.
viv
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ilutio
n sa
mpl
e se
ts w
ere
200
and
5000
par
asite
s/µl
b Pf
line
pos
itive
indi
cate
s a
fals
e-po
sitiv
e P.
falc
ipar
um in
fect
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c Re
sults
pre
sent
ed in
the
tabl
e ar
e ba
sed
on b
and
inte
nsity
of a
pf-
HRP
2 lin
ed
Resu
lts p
rese
nted
in th
e ta
ble
are
base
d on
ban
d in
tens
ity o
f a p
f-pL
DH li
ne
Tabl
e A
4.5
(con
tinue
d)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)96
Tabl
e A
4.6:
Pan
(or
Pv)
tes
t lin
e fa
lse-
posi
tive
rat
e fo
r no
n-Pf
infe
ctio
n on
Pha
se 2
P. f
alci
paru
m s
ampl
es a
t lo
w (
200)
and
hig
h (2
000)
par
asit
e de
nsiti
es (
para
site
s/µl
)
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
P. f
alci
paru
m s
ampl
es (n
=98)
200
para
sites
/μl
2000
a pa
rasit
es/μ
lFa
lse-p
ositi
ve n
on-P
f in
fect
ion
(%)
False
-pos
itive
non
-Pf
infe
ctio
n (%
)
Lot
1 (n
=196
)Lo
t 2
(n=1
96)
Ove
rall
(n=3
92)
Lot
1 (n
=98)
Lot
2 (n
=98)
Ove
rall
(n=1
96)
Pf o
nly
ABON
™ M
alar
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apid
Tes
t Dev
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(Who
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ON B
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arm
(Han
gzho
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tdN
AN
AN
AN
AN
AN
ABI
OCRE
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Mal
aria
pf(H
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R010
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piG
en In
c.N
AN
AN
AN
AN
AN
AFi
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Pf
2100
CB-2
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nim
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tern
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nc.
NA
NA
NA
NA
NA
NA
IND
ONE
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AN
TIG
EN P
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5-11
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Diag
nost
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NA
NA
NA
NA
NA
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can
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alar
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.f An
tigen
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F-50
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dia
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AN
AN
AN
AN
AN
AOn
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est (
Cass
ette
)52
2352
Blue
Cro
ss B
io-M
edic
al (B
eijin
g) C
o., L
td.
NA
NA
NA
NA
NA
NA
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipa
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Mal
aria
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ice
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3030
1025
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NA
NA
NA
NA
NA
Para
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for P
. fal
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ntig
en P
.f. te
stA0
3-11
-322
Artr
on L
abor
ator
ies
Inc.
NA
NA
NA
NA
NA
NA
Won
dfo
One
Step
Mal
aria
P.f
Test
W
37-
CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
NA
NA
NA
NA
NA
NA
Pf a
nd P
anAB
ON™
Plu
s M
alar
ia P
.f/Pa
n Ra
pid
Test
Dev
ice
(Who
le B
lood
)IM
A-T4
02AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td0.
00.
00.
00.
00.
00.
0AZ
OG M
alar
ia p
f (H
RPII)
/pf (
LDH
)/ (P
AN-L
DH) A
ntig
en
Dete
ctio
n De
vice
M
FV-1
24F
AZOG
, IN
C.0.
00.
0 (1
94)
0.0
(390
)0.
00.
00.
0
Core
Mal
aria
Pan
Pf
MAL
-190
024
Core
Dia
gnos
tics
Ltd.
0.0
0.0
0.0
0.0
0.0
0.0
EzDx
™ M
alar
ia P
an/P
f Rap
id T
est D
etec
tion
kit
RK M
AL 0
01Ad
vy C
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iliat
e of
Bha
rat S
erum
s &
Vac
cine
s Lt
d. )
0.0
(195
)0.
50.
3 (3
91)
0.0
0.0
0.0
Firs
tSig
n™ P
araV
iew
(Pan
+Pf)
2101
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
0.5
0.0
0.3
0.0
0.0
0.0
Hum
asis
Mal
aria
P.f/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is, C
o., L
td.
0.0
0.0
0.0
0.0
0.0
0.0
ICT
MAL
ARIA
COM
BOM
L02
ICT
INTE
RNAT
ION
AL0.
01.
00.
50.
0 (9
7)0.
00.
0 (1
95)
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN P
.f/Pa
n TE
ST53
5-10
IND
Diag
nost
ics
Inc.
0.0
0.0
0.0
0.0
0.0
0.0
Mal
aria
Pf/
PAN
GM
004
Gen
omix
Mol
ecul
ar D
iagn
ostic
s Pv
t.Ltd
.0.
00.
50.
30.
00.
00.
0M
alar
ia p
f (H
RP II
)/PAN
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
1-13
-101
-1U
nite
d Bi
otec
h, In
c.
0.0
0.0
0.0
0.0
0.0
0.0
Mal
eris
can®
Mal
aria
P.f/
PAN
(Pv,
Pm, P
o) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PA
N-5
0Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
0.0
0.0
(195
)0.
0 (3
91)
0.0
0.0
0.0
MeD
iPro
Mal
aria
Ag
HRP
2/pL
DH C
ombo
IR-0
051K
Form
osa
Biom
edic
al T
echn
olog
y Co
rp.
0.0
0.0
(195
)0.
0 (3
91)
0.0
0.0
0.0
Nan
oSig
n M
alar
ia p
f/pa
n Ag
3.0
RMAP
10Bi
olan
d Lt
d.1.
00.
50.
80.
00.
00.
0On
Site
Pf/
Pan
Ag R
apid
Tes
tR0
113C
CTK
Biot
ech,
Inc.
0.0
0.0
0.0
0.0
0.0
0.0
Para
HIT
- T
otal
Ver
. 1.0
(Dip
stic
k)55
IC20
3-10
Span
Dia
gnos
tics
Ltd.
0.5
1.0
0.8
0.0
0.0
0.0
Para
HIT
- T
otal
Ver
. 1.0
(Dev
ice)
55IC
204-
10Sp
an D
iagn
ostic
s Lt
d.0.
00.
50.
31.
00.
00.
5Pa
rasc
reen
® -
Rapi
d te
st fo
r Mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
edic
als
0.0
(195
)0.
00.
0 (3
91)
0.0
0.0
0.0
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
an05
FK66
Stan
dard
Dia
gnos
tics
Inc.
2.
00.
0 (1
89)
1.0
(385
)0.
00.
0 (9
7)0.
0 (1
95)
Pf a
nd P
vCa
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOG
0161
Acce
ss B
io, I
nc.
0.0
0.5
0.3
1.0
1.0
1.0
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) COM
BOG
0171
Acce
ss B
io, I
nc.
0.5
0.0
0.3
1.0
0.0
0.5
Falc
iVax
™ -
Rap
id te
st fo
r Mal
aria
Pv/
Pf
5030
0025
Zeph
yr B
iom
edic
als
1.5
0.0
0.8
0.0
0.0
0.0
HiS
ens
Mal
aria
Ag
P.f/
P.v
Com
bo C
ard
HR3
123
HBI
Co.
, Ltd
.0.
0 (1
95)
0.5
0.3
(391
)0.
01.
00.
5H
iSen
s M
alar
ia A
g P.
f/VO
M C
ombo
Car
dH
R332
3H
BI C
o., L
td.
0.0
0.0
0.0
0.0
1.0
0.5
Hum
asis
Mal
aria
P.f/
P.v
Antig
en T
est
AMFV
-702
5H
umas
is, C
o., L
td.
1.0
0.0
0.5
0.0
1.0
0.5
Mal
aria
Pf/
PvG
M00
2G
enom
ix M
olec
ular
Dia
gnos
tics
Pvt.L
td.
0.0
1.5
0.8
1.0
0.0
0.5
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 97
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
P. f
alci
paru
m s
ampl
es (n
=98)
200
para
sites
/μl
2000
a pa
rasit
es/μ
lFa
lse-p
ositi
ve n
on-P
f in
fect
ion
(%)
False
-pos
itive
non
-Pf
infe
ctio
n (%
)
Lot
1 (n
=196
)Lo
t 2
(n=1
96)
Ove
rall
(n=3
92)
Lot
1 (n
=98)
Lot
2 (n
=98)
Ove
rall
(n=1
96)
Mal
aria
pf (
HRP
II) /
pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
1-13
-101
-3U
nite
d Bi
otec
h, In
c.
1.0
0.0
0.5
1.0
(97)
5.1
3.1
(195
)M
edis
enso
r Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOM
161
Med
isen
sor,
Inc.
0.0
0.5
0.3
1.0
1.0
1.0
Med
isen
sor M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) COM
BOM
171
Med
isen
sor,
Inc.
0.5
0.0
0.3
1.0
0.0
0.5
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co.
, Ltd
.0.
00.
00.
00.
00.
00.
0On
Site
Pf/
Pv A
g Ra
pid
Test
R011
2CCT
K Bi
otec
h, In
c.2.
01.
01.
52.
02.
02.
0Pa
raCa
re M
alar
ia H
RP2/
pLDH
(Pf/
Pv) C
OMBO
G01
61Ac
cess
Bio
Eth
iopi
a0.
00.
50.
31.
01.
01.
0Pa
raCa
re M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) COM
BOG
0171
Acce
ss B
io E
thio
pia
0.5
0.0
0.3
1.0
0.0
0.5
RAPI
D 1-
2-3®
HEM
A CA
SSET
TE M
ALAR
IA P
F/PV
TES
TM
AL-P
FV-C
AS/2
5(10
0)H
ema
Diag
nost
ic S
yste
ms,
LLC
0.0
0.0
0.0
0.0
0.0
0.0
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
v05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
0.5
0.0
0.3
1.0
0.0
0.5
Trus
ty™
Mal
aria
Ant
igen
P.f.
/p.v.
test
A03-
12-3
22Ar
tron
Lab
orat
orie
s In
c.8.
717
.913
.311
.3 (9
7)20
.6 (9
7)16
.0 (1
94)
Pan
only
AZOG
hCG
Mal
aria
Det
ectio
n Te
st D
evic
eM
PT-1
24AZ
OG, I
NC.
NA
NA
NA
NA
NA
NA
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
a 5
(5%
) of t
he 9
8 P.
falc
ipar
um d
ilutio
n sa
mpl
es s
ets
wer
e 20
0 an
d 50
00 p
aras
ites/
µl
Tabl
e A
4.6
(con
tinue
d)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)98
Tabl
e A
4.7:
Pha
se 2
fal
se-p
ositi
ve r
ate
for
P. f
alci
paru
m t
est
line
resu
lts
on a
ll m
alar
ia-n
egat
ive
sam
ples
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
Perc
enta
ge o
f fa
lse-p
ositi
ve P
f te
st li
nes
on “
clea
na”
nega
tive
sam
ples
Perc
enta
ge o
f fa
lse-p
ositi
ve P
f te
st li
nes
on
sam
ples
con
tain
ing
no
n-Pl
asm
odiu
m s
pp. i
nfec
tious
age
ntsb
Perc
enta
ge o
f fa
lse-p
ositi
ve P
f te
st li
nes
on
sam
ples
con
tain
ing
im
mun
olog
ical
fac
tors
c
Lot
1
(n=1
16)
Lot
2
(n=1
16)
Ove
rall
(n=2
32)
Lot
1
(n=3
4)Lo
t 2
(n
=34)
Ove
rall
(n=6
8)Lo
t 1
(n
=50)
Lot
2
(n=5
0)O
vera
ll (n
=100
)Pf
onl
yAB
ON™
Mal
aria
P.f.
Rap
id T
est D
evic
e (W
hole
Blo
od)
IMA-
402
ABON
Bio
phar
m (H
angz
hou)
Co.
Ltd
0.9
0.0
0.4
0.0
0.0
0.0
0.0
0.0
0.0
BIOC
REDI
T M
alar
ia p
f(HRP
II)
HR0
100
Rapi
Gen
Inc.
98.3
100.
0 (1
15)
99.1
(231
)79
.494
.186
.894
.010
0.0
97.0
Firs
tSig
n™ M
alar
ia P
f21
00CB
-25
Uni
med
Inte
rnat
iona
l Inc
.2.
6 (1
15)
1.7
2.2
(231
)0.
00.
00.
00.
00.
00.
0IN
D ON
E ST
EP M
ALAR
IA A
NTI
GEN
P.f
535-
11IN
D Di
agno
stic
s In
c.6.
06.
06.
011
.811
.811
.818
.020
.019
.0M
aler
isca
n ®
Mal
aria
P.f
Antig
en T
est
MAT
-PF-
50Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
0.9
0.0
0.4
0.0
0.0
0.0
8.2
(49)
10.0
9.1
(99)
One
Step
Mal
aria
P.F
Tes
t (Ca
sset
te)
5223
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co.
, Ltd
.1.
70.
91.
30.
00.
00.
00.
00.
00.
0Pa
rach
eck®
Pf-
Rapi
d Te
st fo
r P. f
alci
paru
m M
alar
ia
Devi
ce (V
er.3
)30
3010
25Or
chid
Bio
med
ical
Sys
tem
s 1.
70.
91.
30.
00.
00.
00.
00.
00.
0
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipa
rum
Mal
aria
Di
pstic
k (V
er.3
)30
3020
25Or
chid
Bio
med
ical
Sys
tem
s 1.
70.
00.
90.
00.
00.
02.
00.
01.
0
Trus
ty™
Mal
aria
Ant
igen
P.f.
test
A03-
11-3
22Ar
tron
Lab
orat
orie
s In
c.5.
2 (1
15)
5.2
(115
)5.
2 (2
30)
0.0
3.0
(33)
1.5
(67)
6.0
10.0
8.0
Won
dfo
One
Step
Mal
aria
P.f
Test
W
37-
CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
0.9
0.0
(115
)0.
4 (2
31)
5.9
2.9
4.4
2.0
0.0
1.0
Pf a
nd P
anAB
ON™
Plu
s M
alar
ia P
.f/Pa
n Ra
pid
Test
Dev
ice
(Who
le
Bloo
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A-T4
02AB
ON B
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arm
(Han
gzho
u) C
o. L
td0.
00.
90.
40.
00.
00.
08.
012
.010
.0
AZOG
Mal
aria
pf (
HRP
II)/p
f (LD
H)/
(PAN
-LDH
) Ant
igen
De
tect
ion
Devi
ced
MFV
-124
FAZ
OG, I
NC.
0.0
0.9
(115
)0.
4 (2
31)
0.0
0.0
0.0
2.0
6.0
4.0
AZOG
Mal
aria
pf (
HRP
II)/p
f (LD
H)/
(PAN
-LDH
) Ant
igen
De
tect
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Devi
cee
MFV
-124
FAZ
OG, I
NC.
0.9
1.7
(115
)1.
3 (2
31)
0.0
0.0
0.0
10.0
10.0
10.0
Core
Mal
aria
Pan
Pf
MAL
-190
024
Core
Dia
gnos
tics
Ltd.
37.1
27.2
(114
)32
.2 (2
30)
29.4
32.4
30.9
22.0
8.0
15.0
EzDx
™ M
alar
ia P
an/P
f Rap
id T
est D
etec
tion
kit
RK M
AL 0
01Ad
vy C
hem
ical
(Aff
iliat
e of
Bha
rat
Seru
ms
& V
acci
nes
Ltd.
)2.
6 (1
15)
4.3
3.5
(231
)0.
011
.85.
90.
00.
00.
0
Firs
tSig
n™ P
araV
iew
(Pan
+Pf)
2101
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
2.6
2.6
2.6
0.0
0.0
0.0
2.0
0.0
1.0
Hum
asis
Mal
aria
P.f/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is, C
o., L
td.
96.6
99.1
97.8
97.1
100.
098
.596
.010
0.0
98.0
ICT
MAL
ARIA
COM
BOM
L02
ICT
INTE
RNAT
ION
AL0.
90.
00.
40.
00.
00.
04.
04.
04.
0IN
D ON
E ST
EP M
ALAR
IA A
NTI
GEN
P.f/
Pan
TEST
535-
10IN
D Di
agno
stic
s In
c.2.
60.
01.
30.
00.
00.
00.
02.
01.
0M
alar
ia P
f/ P
ANG
M00
4G
enom
ix M
olec
ular
Dia
gnos
tics
Pvt.L
td.
0.0
0.0
0.0
0.0
0.0
0.0
4.0
4.0
4.0
Mal
aria
pf (
HRP
II)/P
AN (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
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13-1
01-1
Uni
ted
Biot
ech,
Inc.
0.
00.
00.
00.
00.
00.
04.
02.
03.
0
Mal
erisc
an®
Mal
aria
P.f/P
AN (P
v, Pm
, Po)
3 Li
ne A
ntig
en Te
stM
AT-P
F/PA
N-5
0Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
2.6
0.0
1.3
0.0
0.0
0.0
6.0
10.0
8.0
MeD
iPro
Mal
aria
Ag
HRP
2/pL
DH C
ombo
IR-0
051K
Form
osa
Biom
edic
al T
echn
olog
y Co
rp.
1.7
0.0
0.9
0.0
0.0
0.0
0.0
2.0
1.0
Nan
oSig
n M
alar
ia p
f/pa
n Ag
3.0
RMAP
10Bi
olan
d Lt
d.0.
90.
00.
40.
00.
00.
02.
00.
01.
0On
Site
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Pan
Ag R
apid
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tR0
113C
CTK
Biot
ech,
Inc.
0.0
0.0
0.0
0.0
0.0
0.0
4.0
4.0
4.0
Para
HIT
- T
otal
Ver
. 1.0
(Dip
stic
k)55
IC20
3-10
Span
Dia
gnos
tics
Ltd.
0.0
0.0
0.0
0.0
0.0
0.0
8.0
8.0
8.0
Para
HIT
- T
otal
Ver
. 1.0
(Dev
ice)
55IC
204-
10Sp
an D
iagn
ostic
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d.0.
00.
00.
00.
00.
00.
012
.012
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rasc
reen
® -
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st fo
r Mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
edic
als
25.9
27.6
26.7
29.4
26.5
27.9
14.3
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aria
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10)
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0 (3
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03.
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and
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eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 99
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
Perc
enta
ge o
f fa
lse-p
ositi
ve P
f te
st li
nes
on “
clea
na”
nega
tive
sam
ples
Perc
enta
ge o
f fa
lse-p
ositi
ve P
f te
st li
nes
on
sam
ples
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tain
ing
no
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m s
pp. i
nfec
tious
age
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Perc
enta
ge o
f fa
lse-p
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ve P
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st li
nes
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tors
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iSen
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ens
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ard
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re M
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ty™
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igen
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1 (9
9)
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licab
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rs w
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e A4
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r det
ails
c
See
Tabl
e A4
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r det
ails
d
Resu
lts p
rese
nted
in
the
tabl
e ar
e ba
sed
on b
and
inte
nsity
of a
pf-
HRP
2 lin
ee
Resu
lts p
rese
nted
in
the
tabl
e ar
e ba
sed
on b
and
inte
nsity
of a
pf-
pLDH
line
Tabl
e A
4.7
(con
tinue
d)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)100
Tabl
e A
4.8:
Pha
se 2
fal
se-p
ositi
ve r
ate
for
P. f
alci
paru
m in
sam
ples
con
tain
ing
spec
ific
non-
mal
aria
l inf
ectio
us p
atho
gens
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
Perc
enta
ge o
f fa
lse-p
ositi
ve f
or P
lasm
odiu
m s
pp. b
y in
fect
ious
pat
hoge
n
Deng
ueSc
hist
osom
iasis
Leish
man
iasis
Chag
as
Lot
1 (n
=8)
Lot
2 (n
=8)
Lot
1 (n
=12)
Lot
2 (n
=12)
Lot
1 (n
=10)
Lot
2 (n
=10)
Lot
1 (n
=4)
Lot
2 (n
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Pf o
nly
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alar
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apid
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t Dev
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2100
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0.0
0.0
0.0
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ONE
STEP
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TIG
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Diag
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25.0
25.0
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can
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004
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00.
00.
00.
00.
00.
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eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 101
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
Perc
enta
ge o
f fa
lse-p
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lasm
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hist
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man
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io E
thio
pia
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/VO
M) C
OMBO
G01
71Ac
cess
Bio
Eth
iopi
a0.
00.
00.
00.
00.
00.
00.
00.
0RA
PID
1-2-
3® H
EMA
CASS
ETTE
MAL
ARIA
PF/
PV T
EST
MAL
-PFV
-CAS
/25(
100)
Hem
a Di
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stic
Sys
tem
s, LL
C0.
00.
00.
00.
010
.010
.00.
00.
0SD
BIO
LIN
E M
alar
ia A
g Pf
/ Pf/
Pva
05FK
100
Stan
dard
Dia
gnos
tics
Inc.
12
.50.
00.
00.
00.
00.
00.
00.
0Tr
usty
™ M
alar
ia A
ntig
en P
.f./p
.v. te
stA0
3-12
-322
Artr
on L
abor
ator
ies
Inc.
25.0
50.0
8.3
8.3
0.0
10.0
0.0
0.0
Pan
only
AZOG
hCG
Mal
aria
Det
ectio
n Te
st D
evic
eM
PT-1
24AZ
OG, I
NC.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Pf, P
lasm
odiu
m fa
lcip
arum
P
v, Pl
asm
odiu
m v
ivax
p
an, P
lasm
odiu
m sp
ecie
sa
Resu
lts p
rese
nted
in th
e ta
ble
is b
ased
on
a p
ositi
ve p
f te
st li
ne (e
ither
pf-
HRP
2 or
pf-
pLDH
)
Tabl
e A
4.8
(con
tinue
d)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)102
Tabl
e A
4.9:
Pha
se 2
fal
se-p
ositi
ve r
ate
for
P. f
alci
paru
m in
sam
ples
con
tain
ing
pote
ntia
lly c
ross
-rea
ctin
g bl
ood
imm
unol
ogic
al f
acto
rs
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
Perc
enta
ge o
f fa
lse-p
ositi
ve f
or P
lasm
odiu
m s
pp. b
y bl
ood
imm
unol
ogic
al f
acto
r
Rheu
mat
oid
fact
orAn
ti-nu
clea
r an
tibod
ies
Anti-
mou
se a
ntib
odie
sRa
pid
plas
ma
reag
in (R
PR)
posit
ive
Lot
1 (n
=8)
Lot
2 (n
=8)
Lot
1 (n
=26)
Lot
2 (n
=26)
Lot
1 (n
=6)
Lot
2 (n
=6)
Lot
1 (n
=10)
Lot
2 (n
=10)
Pf o
nly
ABON
™ M
alar
ia P
.f. R
apid
Tes
t Dev
ice
(Who
le B
lood
)IM
A-40
2AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td0.
00.
00.
00.
00.
00.
00.
00.
0BI
OCRE
DIT
Mal
aria
pf(H
RP II
)H
R010
0Ra
piG
en In
c.10
0.0
100.
092
.310
0.0
100.
010
0.0
90.0
100.
0Fi
rstS
ign™
Mal
aria
Pf
2100
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN P
.f 53
5-11
IND
Diag
nost
ics
Inc.
37.5
50.0
11.5
15.4
33.3
33.3
10.0
0.0
Mal
eris
can
® M
alar
ia P
.f An
tigen
Tes
tM
AT-P
F-50
Bhat
Bio
-Tec
h In
dia
(Pte
.) Lt
d.25
.037
.50.
0 (2
5)0.
033
.333
.30.
00.
0On
e St
ep M
alar
ia P
.F T
est (
Cass
ette
)52
2352
Blue
Cro
ss B
io-M
edic
al (B
eijin
g) C
o., L
td.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipa
rum
Mal
aria
Dev
ice
(Ver
.3)
3030
1025
Orch
id B
iom
edic
al S
yste
ms
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipa
rum
Mal
aria
Dip
stic
k (V
er.3
)30
3020
25Or
chid
Bio
med
ical
Sys
tem
s 0.
00.
00.
00.
00.
00.
010
.00.
0Tr
usty
™ M
alar
ia A
ntig
en P
.f. te
stA0
3-11
-322
Artr
on L
abor
ator
ies
Inc.
25.0
37.5
3.9
0.0
0.0
33.3
0.0
0.0
Won
dfo
One
Step
Mal
aria
P.f
Test
W
37-
CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
0.0
0.0
3.9
0.0
0.0
0.0
0.0
0.0
Pf a
nd P
anAB
ON™
Plu
s M
alar
ia P
.f/Pa
n Ra
pid
Test
Dev
ice
(Who
le B
lood
)IM
A-T4
02AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td25
.025
.00.
07.
750
.033
.30.
00.
0AZ
OG M
alar
ia p
f (H
RPII)
/pf (
LDH
)/ (P
AN-L
DH) A
ntig
en
Dete
ctio
n De
vice
aM
FV-1
24F
AZOG
, IN
C.25
.037
.50.
00.
050
.050
.00.
00.
0
Core
Mal
aria
Pan
Pf
MAL
-190
024
Core
Dia
gnos
tics
Ltd.
12.5
12.5
15.4
3.9
66.7
16.7
20.0
10.0
EzDx
™ M
alar
ia P
an/P
f Rap
id T
est D
etec
tion
kit
RK M
AL 0
01Ad
vy C
hem
ical
(Aff
iliat
e of
Bha
rat S
erum
s &
Vac
cine
s Lt
d. )
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Firs
tSig
n™ P
araV
iew
(Pan
+Pf)
2101
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
0.0
0.0
3.9
0.0
0.0
0.0
0.0
0.0
Hum
asis
Mal
aria
P.f/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is, C
o., L
td.
100.
010
0.0
100.
010
0.0
100.
010
0.0
80.0
100.
0IC
T M
ALAR
IA C
OMBO
ML0
2IC
T IN
TERN
ATIO
NAL
50.0
50.0
7.7
7.7
33.3
33.3
0.0
0.0
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN P
.f/Pa
n TE
ST53
5-10
IND
Diag
nost
ics
Inc.
0.0
0.0
0.0
0.0
0.0
16.7
0.0
0.0
Mal
aria
Pf/
PAN
GM
004
Gen
omix
Mol
ecul
ar D
iagn
ostic
s Pv
t.Ltd
.12
.50.
03.
911
.533
.333
.30.
00.
0M
alar
ia p
f (H
RP II
)/PAN
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
1-13
-101
-1U
nite
d Bi
otec
h, In
c.
0.0
0.0
0.0
0.0
33.3
33.3
0.0
0.0
Mal
eris
can®
Mal
aria
P.f/
PAN
(Pv,
Pm, P
o) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PA
N-5
0Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
25.0
37.5
0.0
0.0
16.7
33.3
0.0
0.0
MeD
iPro
Mal
aria
Ag
HRP
2/pL
DH C
ombo
IR-0
051K
Form
osa
Biom
edic
al T
echn
olog
y Co
rp.
25.0
25.0
0.0
3.9
33.3
33.3
0.0
0.0
Nan
oSig
n M
alar
ia p
f/pa
n Ag
3.0
RMAP
10Bi
olan
d Lt
d.12
.50.
00.
00.
016
.70.
00.
00.
0On
Site
Pf/
Pan
Ag R
apid
Tes
tR0
113C
CTK
Biot
ech,
Inc.
25.0
25.0
11.5
15.4
100.
010
0.0
0.0
0.0
Para
HIT
- T
otal
Ver
. 1.0
(Dip
stic
k)55
IC20
3-10
Span
Dia
gnos
tics
Ltd.
25.0
25.0
0.0
3.9
33.3
33.3
0.0
0.0
Para
HIT
- T
otal
Ver
. 1.0
(Dev
ice)
55IC
204-
10Sp
an D
iagn
ostic
s Lt
d.25
.025
.00.
03.
966
.766
.70.
00.
0Pa
rasc
reen
® -
Rapi
d te
st fo
r Mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
edic
als
0.0
0.0
16.0
(25)
0.0
16.7
33.3
20.0
0.0
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
an05
FK66
Stan
dard
Dia
gnos
tics
Inc.
0.
00.
00.
00.
016
.733
.30.
00.
0Pf
and
Pv
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/
Pv) C
OMBO
G01
61Ac
cess
Bio
, Inc
.0.
00.
07.
70.
00.
00.
00.
00.
0Ca
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/VO
M) C
OMBO
G01
71Ac
cess
Bio
, Inc
.0.
012
.50.
00.
00.
00.
00.
00.
0Fa
lciV
ax™
- R
apid
test
for M
alar
ia P
v/Pf
50
3000
25Ze
phyr
Bio
med
ical
s0.
00.
03.
90.
016
.70.
00.
00.
0H
iSen
s M
alar
ia A
g P.
f/P.
v Co
mbo
Car
dH
R312
3H
BI C
o., L
td.
0.0
0.0
3.9
11.5
0.0
0.0
0.0
0.0
HiS
ens
Mal
aria
Ag
P.f/
VOM
Com
bo C
ard
HR3
323
HBI
Co.
, Ltd
.0.
00.
00.
00.
00.
00.
00.
00.
0H
umas
is M
alar
ia P
.f/P.
v An
tigen
Tes
tAM
FV-7
025
Hum
asis,
Co.
, Ltd
.12
.50.
00.
03.
966
.766
.70.
00.
0M
alar
ia P
f/Pv
GM
002
Gen
omix
Mol
ecul
ar D
iagn
ostic
s Pv
t.Ltd
.0.
00.
00.
00.
033
.333
.30.
010
.0
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 103
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
Perc
enta
ge o
f fa
lse-p
ositi
ve f
or P
lasm
odiu
m s
pp. b
y bl
ood
imm
unol
ogic
al f
acto
r
Rheu
mat
oid
fact
orAn
ti-nu
clea
r an
tibod
ies
Anti-
mou
se a
ntib
odie
sRa
pid
plas
ma
reag
in (R
PR)
posit
ive
Lot
1 (n
=8)
Lot
2 (n
=8)
Lot
1 (n
=26)
Lot
2 (n
=26)
Lot
1 (n
=6)
Lot
2 (n
=6)
Lot
1 (n
=10)
Lot
2 (n
=10)
Mal
aria
pf (
HRP
II) /
pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
1-13
-101
-3U
nite
d Bi
otec
h, In
c.
0.0
0.0
0.0
0.0
33.3
33.3
0.0
0.0
Med
isen
sor M
alar
ia H
RP2/
pLDH
(Pf/
Pv) C
OMBO
M16
1M
edis
enso
r, In
c.0.
00.
07.
70.
00.
00.
00.
00.
0M
edis
enso
r Mal
aria
HRP
2/pL
DH (P
f/VO
M) C
OMBO
M17
1M
edis
enso
r, In
c.0.
012
.50.
00.
00.
00.
00.
00.
0On
e St
ep M
alar
ia P
.F/P
.V T
est (
Cass
ette
)52
3352
Blue
Cro
ss B
io-M
edic
al (B
eijin
g) C
o., L
td.
25.0
25.0
0.0
0.0
0.0
0.0
0.0
0.0
OnSi
te P
f/Pv
Ag
Rapi
d Te
stR0
112C
CTK
Biot
ech,
Inc.
25.0
25.0
7.7
7.7
66.7
66.7
0.0
0.0
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOG
0161
Acce
ss B
io E
thio
pia
0.0
0.0
7.7
0.0
0.0
0.0
0.0
0.0
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/VO
M) C
OMBO
G01
71Ac
cess
Bio
Eth
iopi
a0.
012
.50.
00.
00.
00.
00.
00.
0RA
PID
1-2-
3® H
EMA
CASS
ETTE
MAL
ARIA
PF/
PV T
EST
MAL
-PFV
-CAS
/25(
100)
Hem
a Di
agno
stic
Sys
tem
s, LL
C0.
00.
03.
90.
00.
00.
00.
00.
0SD
BIO
LIN
E M
alar
ia A
g Pf
/ Pf/
Pva
05FK
100
Stan
dard
Dia
gnos
tics
Inc.
0.
00.
00.
00.
033
.333
.30.
00.
0Tr
usty
™ M
alar
ia A
ntig
en P
.f./p
.v. te
stA0
3-12
-322
Artr
on L
abor
ator
ies
Inc.
62.5
62.5
23.1
11.5
50.0
66.7
0.0
0.0
Pan
only
AZOG
hCG
Mal
aria
Det
ectio
n Te
st D
evic
eM
PT-1
24AZ
OG, I
NC.
0.0
25.0
0.0
(25)
0.0
16.7
33.3
0.0
0.0
Pf, P
lasm
odiu
m fa
lcip
arum
P
v, Pl
asm
odiu
m v
ivax
p
an, P
lasm
odiu
m sp
ecie
sa
Resu
lts p
rese
nted
in th
e ta
ble
is b
ased
on
a p
ositi
ve p
f tes
t lin
e (e
ither
pf-
HRP
2 or
pf-
pLDH
)
Tabl
e A
4.9
(con
tinue
d)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)104
Tabl
e A
4.10
: Pha
se 2
fal
se-p
ositi
ve r
ate
of p
an t
est
line
resu
lts
on a
ll m
alar
ia-n
egat
ive
sam
ples
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
Perc
enta
ge o
f fa
lse-p
ositi
ve p
an
test
line
s on
“cl
eana
” ne
gativ
e sa
mpl
es
Perc
enta
ge o
f fa
lse-p
ositi
ve p
an
test
line
s on
sam
ples
con
tain
ing
no
n-Pl
asm
odiu
m s
pp. i
nfec
tious
age
ntsb
Perc
enta
ge o
f fa
lse-p
ositi
ve p
an
test
line
s on
sam
ples
con
tain
ing
imm
unol
ogic
al f
acto
rsc
Lot
1 (n
=116
)Lot
2 (n
=116
)O
vera
ll (n
=232
)Lo
t 1
(n
=34)
Lot
2
(n=3
4)O
vera
ll (n
=68)
Lot
1
(n=5
0)Lo
t 2
(n
=50)
Ove
rall
(n=1
00)
Pf o
nly
ABON
™ M
alar
ia P
.f. R
apid
Tes
t Dev
ice
(Who
le B
lood
)IM
A-40
2AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
tdN
AN
AN
AN
AN
AN
AN
AN
AN
ABI
OCRE
DIT
Mal
aria
pf(H
RP II
)H
R010
0Ra
piG
en In
c.N
AN
AN
AN
AN
AN
AN
AN
AN
AFi
rstS
ign™
Mal
aria
Pf
2100
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
NA
NA
NA
NA
NA
NA
NA
NA
NA
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN P
.f 53
5-11
IND
Diag
nost
ics
Inc.
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
eris
can
® M
alar
ia P
.f An
tigen
Tes
tM
AT-P
F-50
Bhat
Bio
-Tec
h In
dia
(Pte
.) Lt
d.N
AN
AN
AN
AN
AN
AN
AN
AN
AOn
e St
ep M
alar
ia P
.F T
est (
Cass
ette
)52
2352
Blue
Cro
ss B
io-M
edic
al (B
eijin
g) C
o., L
td.
NA
NA
NA
NA
NA
NA
NA
NA
NA
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipar
um M
alar
ia D
evic
e (V
er.3
)30
3010
25Or
chid
Bio
med
ical
Sys
tem
s N
AN
AN
AN
AN
AN
AN
AN
AN
APa
rach
eck®
Pf-
Rapi
d Te
st fo
r P. fa
lcipa
rum
Mal
aria
Dip
stic
k (Ve
r.3)
3030
2025
Orch
id B
iom
edic
al S
yste
ms
NA
NA
NA
NA
NA
NA
NA
NA
NA
Trus
ty™
Mal
aria
Ant
igen
P.f.
test
A03-
11-3
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ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 105
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
Perc
enta
ge o
f fa
lse-p
ositi
ve p
an
test
line
s on
“cl
eana
” ne
gativ
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mpl
es
Perc
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f fa
lse-p
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an
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s on
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no
n-Pl
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m s
pp. i
nfec
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age
ntsb
Perc
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f fa
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s on
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imm
unol
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acto
rsc
Lot
1 (n
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vera
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Lot
2
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4)O
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Lot
1
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0)Lo
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Ove
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Mal
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pf (
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pv
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Test
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alar
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
One
Step
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P.F
/P.V
Tes
t (Ca
sset
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5233
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ross
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Co.
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00.
00.
00.
00.
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00.
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Site
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0.4
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0.0
0.0
0.0
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Trus
ty™
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/p.v.
test
A03-
12-3
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tron
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s In
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45.7
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lyAZ
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alar
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Test
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MPT
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61.
72.
20.
00.
00.
02.
0 (4
9)8.
05.
1 (9
9)
NA,
not
app
licab
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smod
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falc
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um
Pv,
Plas
mod
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viv
ax
pan
, Pla
smod
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spec
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a Bl
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sam
ples
from
hea
lthy
volu
ntee
rs w
ith n
o kn
own
curr
ent i
llnes
s or
blo
od a
bnor
mal
ityb
See
Tabl
e A4
.8 fo
r det
ails
c
See
Tabl
e A4
.9 fo
r det
ails
d
Pan
test
line
e P.
viv
ax te
st li
ne
Tabl
e A
4.10
(co
ntin
ued)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)106
Tabl
e A
4.11
: Hea
t st
abili
ty t
estin
g re
sult
s fo
r P.
fal
cipa
rum
(or
pan
a ) t
est
line
on a
P. f
alci
paru
m s
ampl
es a
t lo
w p
aras
ite
dens
ity
(200
par
asit
es/µ
l).
Posi
tivi
ty r
ate
at b
asel
ine,
and
aft
er 6
0 da
ys in
cuba
tion
at 4
°C, 3
5°C
and
45°C
b
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35°C
45°C
4°C
Lot
1 (n
=15)
Lot
2 (n
=15)
Lot
1 (n
=15)
Lot
2 (n
=15)
Lot
1 (n
=15)
Lot
2 (n
=15)
Lot
1 (n
=15)
Lot
2 (n
=15)
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
Pf o
nly
ABON
™ M
alar
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apid
Tes
t Dev
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le
Bloo
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A-40
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ON B
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gzho
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00.
015
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01.
115
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01.
00.
00.
00.
014
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01.
03.
00.
01.
014
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01.
02.
00.
01.
0
BIOC
REDI
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f(HRP
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3.0
15.0
0.0
3.0
15.0
0.0
3.0
15.0
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tSig
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alar
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-25
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med
Inte
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02.
015
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03.
015
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02.
015
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02.
215
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03.
015
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02.
115
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815
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01.
015
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01.
015
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01.
215
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011
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015
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015
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01.
0M
aler
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Mal
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Antig
en T
est
MAT
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at B
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ech
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te.)
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2.0
15.0
0.0
1.9
15.0
0.0
2.0
15.0
0.0
1.7
15.0
0.0
1.5
15.0
0.0
1.9
15.0
0.0
1.7
15.0
0.0
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One
Step
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aria
P.F
Tes
t (Ca
sset
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5223
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ross
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jing)
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02.
115
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02.
315
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03.
015
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02.
115
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02.
915
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02.
915
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02.
815
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02.
9
Para
chec
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pid
Test
for P
. fal
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M
alar
ia D
evic
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3010
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chid
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tem
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02.
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03.
915
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03.
015
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02.
915
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02.
915
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02.
915
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03.
015
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02.
7
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipa
rum
M
alar
ia D
ipst
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(Ver
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3030
2025
Orch
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15.0
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15.0
0.0
1.9
14.0
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1.6
15.0
0.0
1.9
15.0
0.0
1.9
15.0
0.0
2.0
15.0
0.0
1.8
Trus
ty™
Mal
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test
A03-
11-3
22Ar
tron
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s In
c.15
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015
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01.
015
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01.
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1Pf
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hole
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T402
ABON
Bio
phar
m (H
angz
hou)
Co
. Ltd
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0.0
2.0
15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
1.5
15.0
0.0
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Mal
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pf
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f (L
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214
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115
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Core
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Seru
ms
& V
acci
nes
Ltd.
)15
.00.
01.
715
.00.
02.
015
.00.
01.
915
.00.
02.
015
.00.
01.
915
.00.
02.
015
.00.
01.
115
.00.
02.
0
Firs
tSig
n™ P
araV
iew
(Pan
+Pf)
2101
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
14.0
1.0
2.0
15.0
0.0
3.0
15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
3.0
15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
2.0
Hum
asis
Mal
aria
P.f/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is, C
o., L
td.
15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
2.2
15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
3.0
ICT
MAL
ARIA
COM
BOM
L02
ICT
INTE
RNAT
ION
AL15
.00.
01.
714
.00.
01.
815
.00.
02.
014
.00.
01.
615
.00.
01.
913
.00.
01.
515
.00.
02.
015
.00.
01.
5IN
D ON
E ST
EP M
ALAR
IA A
NTI
GEN
P.f/
Pan
TEST
535-
10IN
D Di
agno
stic
s In
c.15
.00.
02.
115
.00.
02.
715
.00.
02.
715
.00.
02.
015
.00.
02.
015
.00.
03.
015
.00.
02.
215
.00.
03.
0
Mal
aria
Pf/
PAN
GM
004
Gen
omix
Mol
ecul
ar D
iagn
ostic
s Pv
t.Ltd
.3.
00.
01.
014
.00.
01.
06.
00.
01.
01.
00.
01.
00.
00.
00.
08.
00.
01.
015
.00.
01.
012
.00.
01.
1
Mal
aria
pf (
HRP
II)/P
AN (p
LDH)
Ant
igen
Det
ectio
n Te
st D
evic
e1-
13-1
01-1
Uni
ted
Biot
ech,
Inc.
15
.00.
01.
015
.00.
01.
614
.00.
01.
015
.00.
01.
315
.00.
01.
014
.00.
01.
015
.00.
01.
015
.00.
01.
0
Mal
eris
can®
Mal
aria
P.f/
PAN
(Pv,
Pm, P
o) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PA
N-5
0Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
15.0
0.0
2.0
15.0
0.0
1.5
15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
1.5
15.0
0.0
2.0
15.0
0.0
1.6
15.0
0.0
2.0
MeD
iPro
Mal
aria
Ag
HRP
2/pL
DH C
ombo
IR-0
051K
Form
osa
Biom
edic
al T
echn
olog
y Co
rp.
15.0
0.0
1.6
15.0
0.0
1.0
15.0
0.0
1.1
14.0
0.0
1.0
15.0
0.0
1.0
14.0
0.0
1.0
15.0
0.0
1.1
15.0
0.0
1.0
Nan
oSig
n M
alar
ia p
f/pa
n Ag
3.0
RMAP
10Bi
olan
d Lt
d.15
.00.
03.
015
.00.
02.
915
.00.
02.
215
.00.
02.
015
.00.
02.
015
.00.
02.
515
.00.
02.
215
.00.
02.
1On
Site
Pf/
Pan
Ag R
apid
Tes
tR0
113C
CTK
Biot
ech,
Inc.
15.0
0.0
2.0
15.0
0.0
1.0
15.0
0.0
1.0
15.0
0.0
1.0
15.0
0.0
1.0
13.0
0.0
1.0
15.0
0.0
2.0
15.0
0.0
1.0
Para
HIT
- T
otal
(Dip
stic
k)55
IC20
1-10
Span
Dia
gnos
tics
Ltd.
15.0
0.0
2.0
15.0
0.0
1.5
15.0
0.0
2.0
13.0
0.0
1.5
7.0
5.0
1.1
7.0
4.0
1.7
15.0
0.0
2.0
15.0
0.0
2.0
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 107
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35°C
45°C
4°C
Lot
1 (n
=15)
Lot
2 (n
=15)
Lot
1 (n
=15)
Lot
2 (n
=15)
Lot
1 (n
=15)
Lot
2 (n
=15)
Lot
1 (n
=15)
Lot
2 (n
=15)
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
Para
HIT
- T
otal
(Dev
ice)
55IC
202-
10Sp
an D
iagn
ostic
s Lt
d.15
.00.
02.
015
.00.
02.
015
.00.
02.
015
.00.
02.
015
.00.
02.
015
.00.
01.
915
.00.
02.
015
.00.
02.
0Pa
rasc
reen
® -
Rapi
d te
st fo
r Mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
edic
als
15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
3.0
15.0
0.0
2.3
15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
2.3
15.0
0.0
2.0
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
an05
FK66
Stan
dard
Dia
gnos
tics
Inc.
15
.00.
02.
914
.01.
02.
014
.01.
02.
315
.00.
02.
515
.00.
02.
115
.00.
02.
815
.00.
02.
715
.00.
03.
0Pf
and
Pv
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/P
v) C
OMBO
G01
61Ac
cess
Bio
, Inc
.15
.00.
02.
815
.00.
02.
415
.00.
03.
015
.00.
02.
515
.00.
01.
915
.00.
02.
015
.00.
02.
015
.00.
02.
0Ca
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/VOM
) COM
BOG
0171
Acce
ss B
io, I
nc.
15.0
0.0
2.7
15.0
0.0
2.9
15.0
0.0
2.9
15.0
0.0
2.8
15.0
0.0
2.0
15.0
0.0
2.3
15.0
0.0
2.8
15.0
0.0
1.9
Falc
iVax
™ -
Rap
id te
st fo
r Mal
aria
Pv/
Pf
5030
0025
Zeph
yr B
iom
edic
als
15.0
0.0
2.2
15.0
0.0
2.1
15.0
0.0
3.0
15.0
0.0
2.2
15.0
0.0
2.1
15.0
0.0
2.1
15.0
0.0
2.7
15.0
0.0
2.0
HiS
ens
Mal
aria
Ag
P.f/
P.v
Com
bo C
ard
HR3
123
HBI
Co.
, Ltd
.15
.00.
03.
015
.00.
02.
015
.00.
02.
715
.00.
02.
815
.00.
02.
515
.00.
01.
915
.00.
02.
515
.00.
02.
5H
iSen
s M
alar
ia A
g P.
f/VO
M C
ombo
Car
dH
R332
3H
BI C
o., L
td.
15.0
0.0
2.9
15.0
0.0
1.9
15.0
0.0
2.3
15.0
0.0
2.4
15.0
0.0
2.7
15.0
0.0
2.0
15.0
0.0
2.1
15.0
0.0
2.7
Hum
asis
Mal
aria
P.f/
P.v
Antig
en T
est
AMFV
-702
5H
umas
is, C
o., L
td.
15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
2.0
Mal
aria
Pf/
PvG
M00
2G
enom
ix M
olec
ular
Dia
gnos
tics
Pv
t.Ltd
.4.
00.
01.
08.
00.
01.
09.
00.
01.
01.
00.
01.
00.
00.
00.
012
.00.
01.
015
.00.
01.
013
.00.
01.
0
Mal
aria
pf (
HRP
II) /
pv (p
LDH)
Ant
igen
Det
ectio
n Te
st D
evic
e1-
13-1
01-3
Uni
ted
Biot
ech,
Inc.
15
.00.
01.
115
.00.
01.
815
.00.
01.
015
.00.
01.
615
.00.
01.
015
.00.
01.
015
.00.
01.
015
.00.
01.
1
Med
isens
or M
alar
ia H
RP2/
pLDH
(Pf/P
v) C
OMBO
M16
1M
edis
enso
r, In
c.15
.00.
02.
815
.00.
02.
415
.00.
03.
015
.00.
02.
515
.00.
01.
915
.00.
02.
015
.00.
02.
015
.00.
02.
0M
edise
nsor
Mal
aria
HRP
2/pL
DH (P
f/VOM
) COM
BOM
171
Med
isen
sor,
Inc.
15.0
0.0
2.7
15.0
0.0
2.9
15.0
0.0
2.9
15.0
0.0
2.8
15.0
0.0
2.0
15.0
0.0
2.3
15.0
0.0
2.8
15.0
0.0
1.9
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
52Bl
ue C
ross
Bio
-Med
ical
(Be
ijing
) Co
., Lt
d.8.
00.
01.
04.
00.
01.
02.
00.
01.
00.
00.
00.
00.
00.
00.
00.
00.
00.
04.
00.
01.
00.
00.
00.
0
OnSi
te P
f/Pv
Ag
Rapi
d Te
stR0
112C
CTK
Biot
ech,
Inc.
15.0
0.0
2.0
15.0
0.0
1.4
15.0
0.0
1.0
15.0
0.0
1.0
13.0
0.0
1.0
14.0
0.0
1.0
15.0
0.0
2.0
15.0
0.0
1.0
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOG
0161
Acce
ss B
io E
thio
pia
15.0
0.0
2.8
15.0
0.0
2.4
15.0
0.0
3.0
15.0
0.0
2.5
15.0
0.0
1.9
15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
2.0
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/VOM
) COM
BOG
0171
Acce
ss B
io E
thio
pia
15.0
0.0
2.7
15.0
0.0
2.9
15.0
0.0
2.9
15.0
0.0
2.8
15.0
0.0
2.0
15.0
0.0
2.3
15.0
0.0
2.8
15.0
0.0
1.9
RAPI
D 1-
2-3®
HEM
A CA
SSET
TE M
ALAR
IA P
F/PV
TES
TM
AL
-P
FV
-CA
S/25
(100
)H
ema
Diag
nost
ic S
yste
ms,
LLC
15.0
0.0
2.0
15.0
0.0
2.1
15.0
0.0
2.9
15.0
0.0
2.2
15.0
0.0
2.9
15.0
0.0
2.8
15.0
0.0
2.8
15.0
0.0
2.8
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
vc05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
15.0
0.0
2.5
15.0
0.0
2.5
15.0
0.0
2.5
15.0
0.0
3.4
15.0
0.0
2.5
14.0
1.0
2.9
15.0
0.0
2.7
15.0
0.0
3.0
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
vd05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
4.0
0.0
1.0
4.0
0.0
1.0
1.0
0.0
1.0
0.0
0.0
0.0
0.0
0.0
0.0
1.0
1.0
1.0
6.0
0.0
1.0
0.0
0.0
0.0
Trus
ty™
Mal
aria
Ant
igen
P.f.
/p.v.
test
A03-
12-3
22Ar
tron
Lab
orat
orie
s In
c.15
.00.
01.
615
.00.
01.
015
.00.
01.
015
.00.
01.
65.
00.
01.
06.
00.
01.
015
.00.
01.
115
.00.
01.
9Pa
n on
lyAZ
OG h
CG M
alar
ia D
etec
tion
Test
Dev
ice
MPT
-124
AZOG
, IN
C.15
.00.
01.
015
.00.
01.
515
.00.
01.
615
.00.
01.
315
.00.
00.
915
.00.
01.
015
.00.
01.
015
.00.
01.
0
ND,
not
det
erm
ined
Pf, P
lasm
odiu
m fa
lcip
arum
P
v, Pl
asm
odiu
m v
ivax
p
an, P
lasm
odiu
m sp
ecie
sa
For p
an-o
nly
test
sb
Posi
tive
resu
lts p
rese
nted
in th
e ta
ble
are
base
d on
sta
bilit
y of
a p
ositi
ve re
ader
1 o
r rea
der 2
resu
ltc
Resu
lts p
rese
nted
in th
e ta
ble
are
base
d on
ban
d in
tens
ity o
f a p
f-H
RP2
line
d Re
sults
pre
sent
ed in
the
tabl
e ar
e ba
sed
on b
and
inte
nsity
of a
pf-
pLDH
line
Tabl
e A
4.11
(co
ntin
ued)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)108
Tabl
e A
4.11
a: H
eat
stab
ility
tes
ting
resu
lts
for
pan
test
line
of
com
bina
tion
RDTs
on
a P.
fal
cipa
rum
sam
ple
at lo
w p
aras
ite
dens
ity
(200
par
asit
es/µ
l).
Posi
tivi
ty r
ate
at b
asel
ine,
and
aft
er 6
0 da
ys in
cuba
tion
at 4
°C, 3
5°C
and
45°C
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35°C
45°C
4°C
Lot
1 (n
=15)
Lot
2 (n
=15)
Lot
1 (n
=15)
Lot
2 (n
=15)
Lot
1 (n
=15)
Lot
2 (n
=15)
Lot
1 (n
=15)
Lot
2 (n
=15)
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
Pf a
nd P
anAB
ON™
Plu
s M
alar
ia P
.f/Pa
n Ra
pid
Test
Dev
ice
(Who
le B
lood
)IM
A-T4
02AB
ON B
ioph
arm
(Han
gzho
u) C
o. Lt
d0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
AZOG
Mal
aria
pf
(HRP
II)/p
f (L
DH)/
(PAN
-LDH
) An
tigen
Det
ectio
n De
vice
M
FV-1
24F
AZOG
, IN
C.0.
00.
00.
01.
00.
01.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Core
Mal
aria
Pan
Pf
MAL
-190
024
Core
Dia
gnos
tics
Ltd.
0.0
0.0
0.0
8.0
0.0
1.0
10.0
0.0
1.0
14.0
0.0
1.0
10.0
0.0
1.0
15.0
0.0
1.0
15.0
0.0
1.0
8.0
0.0
1.0
EzDx
™ M
alar
ia P
an/P
f Rap
id T
est D
etec
tion
kit
RK M
AL 0
01Ad
vy C
hem
ical
(Aff
iliat
e of
Bha
rat
Seru
ms
& V
acci
nes
Ltd.
)0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Firs
tSig
n™ P
araV
iew
(Pan
+Pf)
2101
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
0.0
1.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
3.0
0.0
1.0
1.0
0.0
1.0
0.0
0.0
0.0
0.0
0.0
0.0
Hum
asis
Mal
aria
P.f/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is, C
o., L
td.
15.0
0.0
1.0
8.0
0.0
1.0
15.0
0.0
1.1
15.0
0.0
1.0
15.0
0.0
1.0
15.0
0.0
1.0
15.0
0.0
1.0
15.0
0.0
1.0
ICT
MAL
ARIA
COM
BOM
L02
ICT
INTE
RNAT
ION
AL1.
00.
01.
00.
00.
00.
05.
00.
01.
01.
00.
01.
02.
00.
01.
02.
00.
01.
03.
00.
01.
70.
00.
00.
0IN
D ON
E ST
EP M
ALAR
IA A
NTI
GEN
P.f/
Pan
TEST
535-
10IN
D Di
agno
stic
s Inc
.0.
00.
00.
06.
00.
01.
00.
00.
00.
01.
00.
01.
00.
00.
00.
010
.00.
01.
09.
00.
01.
00.
00.
00.
0
Mal
aria
Pf/
PAN
GM
004
Gen
omix
Mol
ecul
ar D
iagn
osti
cs
Pvt.L
td.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Mal
aria
pf (
HRP
II)/P
AN (p
LDH)
Ant
igen
Det
ectio
n Te
st D
evic
e1-
13-1
01-1
Uni
ted
Biot
ech,
Inc.
0.
00.
00.
05.
00.
01.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Mal
eris
can®
Mal
aria
P.f/
PAN
(Pv,
Pm, P
o) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PA
N-5
0Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
MeD
iPro
Mal
aria
Ag
HRP
2/pL
DH C
ombo
IR-0
051K
Form
osa
Biom
edica
l Tec
hnol
ogy C
orp.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Nan
oSig
n M
alar
ia p
f/pa
n Ag
3.0
RMAP
10Bi
olan
d Lt
d.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0On
Site
Pf/
Pan
Ag R
apid
Tes
tR0
113C
CTK
Biot
ech,
Inc.
0.0
0.0
0.0
0.0
0.0
0.0
1.0
0.0
1.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Para
HIT
- T
otal
Ver
. 1.0
(Dip
stic
k)55
IC20
3-10
Span
Dia
gnos
tics
Ltd.
0.0
0.0
0.0
15.0
0.0
1.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
5.0
0.0
0.0
4.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Para
HIT
- T
otal
Ver
. 1.0
(Dev
ice)
55IC
204-
10Sp
an D
iagn
ostic
s Lt
d.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0Pa
rasc
reen
® -
Rapi
d te
st fo
r Mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
edic
als
12.0
0.0
1.0
14.0
0.0
1.0
3.0
0.0
1.0
1.0
0.0
1.0
14.0
0.0
1.0
11.0
0.0
1.0
15.0
0.0
1.0
0.0
0.0
0.0
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
an05
FK66
Stan
dard
Dia
gnos
tics
Inc.
0.
00.
00.
05.
01.
00.
80.
01.
00.
03.
00.
01.
00.
00.
00.
00.
00.
00.
09.
00.
01.
00.
00.
00.
0Pf
and
Pv
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/P
v) C
OMBO
G01
61Ac
cess
Bio
, Inc
.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
ACa
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/VOM
) COM
BOG
0171
Acce
ss B
io, I
nc.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Falc
iVax
™ -
Rap
id te
st fo
r Mal
aria
Pv/
Pf
5030
0025
Zeph
yr B
iom
edic
als
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
HiS
ens
Mal
aria
Ag
P.f/
P.v
Com
bo C
ard
HR3
123
HBI
Co.
, Ltd
.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AH
iSen
s M
alar
ia A
g P.
f/VO
M C
ombo
Car
dH
R332
3H
BI C
o., L
td.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Hum
asis
Mal
aria
P.f/
P.v
Antig
en T
est
AMFV
-702
5H
umas
is, C
o., L
td.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
aria
Pf/
PvG
M00
2G
enom
ix M
olec
ular
Dia
gnos
tics
Pvt.L
td.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
aria
pf (
HRP
II) /
pv
(pLD
H) A
ntig
en
Dete
ctio
n Te
st D
evic
e1-
13-1
01-3
Uni
ted
Biot
ech,
Inc.
N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Med
isens
or M
alar
ia H
RP2/
pLDH
(Pf/P
v) C
OMBO
M16
1M
edis
enso
r, In
c.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AM
edise
nsor
Mal
aria
HRP
2/pL
DH (P
f/VOM
) COM
BOM
171
Med
isen
sor,
Inc.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co
., Lt
d.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 109
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35°C
45°C
4°C
Lot
1 (n
=15)
Lot
2 (n
=15)
Lot
1 (n
=15)
Lot
2 (n
=15)
Lot
1 (n
=15)
Lot
2 (n
=15)
Lot
1 (n
=15)
Lot
2 (n
=15)
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
OnSi
te P
f/Pv
Ag
Rapi
d Te
stR0
112C
CTK
Biot
ech,
Inc.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOG
0161
Acce
ss B
io E
thio
pia
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/VOM
) COM
BOG
0171
Acce
ss B
io E
thio
pia
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
RAPI
D 1-
2-3®
HEM
A CA
SSET
TE M
ALAR
IA P
F/PV
TES
TM
AL-P
FV-
CAS/
25(1
00)
Hem
a Di
agno
stic
Sys
tem
s, LL
CN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
v05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Trus
ty™
Mal
aria
Ant
igen
P.f.
/p.v.
test
A03-
12-3
22Ar
tron
Lab
orat
orie
s In
c.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
a Po
sitiv
e re
sults
pre
sent
ed in
the
tabl
e ar
e ba
sed
on s
tabi
lity
of a
pos
itive
read
er 1
or r
eade
r 2 re
sult
Tabl
e A
4.11
a (c
ontin
ued)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)110
Tabl
e A
4.12
: Hea
t st
abili
ty t
estin
g re
sult
s fo
r P.
fal
cipa
rum
(or
pan
a ) t
est
line
on a
P. f
alci
paru
m s
ampl
es a
t hi
gh p
aras
ite
dens
ity
(200
0 pa
rasi
tes/
µl).
Po
siti
vity
rat
e at
bas
elin
e, a
nd a
fter
60
days
incu
batio
n at
4°C
, 35°
C an
d 45
°C
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35°C
45°C
4°C
Lot
1 (n
=5)
Lot
2 (n
=5)
Lot
1 (n
=5)
Lot
2 (n
=5)
Lot
1 (n
=5)
Lot
2 (n
=5)
Lot
1 (n
=5)
Lot
2 (n
=5)
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
Pf o
nly
ABON
™ M
alar
ia P.
f. Ra
pid
Test
Dev
ice (W
hole
Bloo
d)IM
A-40
2AB
ON B
ioph
arm
(Han
gzho
u) C
o. Lt
d5.
00.
02.
05.
00.
02.
05.
00.
01.
85.
00.
01.
45.
00.
02.
25.
00.
02.
05.
00.
01.
85.
00.
02.
0BI
OCRE
DIT
Mal
aria
pf(H
RP II
)H
R010
0Ra
piG
en In
c.5.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
0Fi
rstS
ign™
Mal
aria
Pf
2100
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN P
.f 53
5-11
IND
Diag
nost
ics
Inc.
5.0
0.0
2.8
5.0
0.0
3.2
5.0
0.0
4.0
5.0
0.0
3.0
5.0
0.0
2.0
5.0
0.0
2.6
5.0
0.0
2.6
5.0
0.0
4.0
Mal
eris
can
® M
alar
ia P
.f An
tigen
Tes
tM
AT-P
F-50
Bhat
Bio
-Tec
h In
dia
(Pte
.) Lt
d.5.
00.
03.
45.
00.
03.
65.
00.
03.
65.
00.
04.
05.
00.
03.
25.
00.
03.
85.
00.
03.
05.
00.
03.
0
One
Step
Mal
aria
P.F
Tes
t (Ca
sset
te)
5223
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co
., Ltd
.5.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
0
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipa
rum
M
alar
ia D
evic
e (V
er.3
)30
3010
25Or
chid
Bio
med
ical
Sys
tem
s 5.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
0
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipa
rum
M
alar
ia D
ipst
ick
(Ver
.3)
3030
2025
Orch
id B
iom
edic
al S
yste
ms
5.0
0.0
3.4
5.0
0.0
3.2
5.0
0.0
3.8
5.0
0.0
3.4
5.0
0.0
4.0
5.0
0.0
3.4
5.0
0.0
4.0
5.0
0.0
3.6
Trus
ty™
Mal
aria
Ant
igen
P.f.
test
A03-
11-3
22Ar
tron
Lab
orat
orie
s In
c.5.
00.
03.
45.
00.
04.
05.
00.
03.
05.
00.
03.
25.
00.
01.
65.
00.
02.
05.
00.
03.
05.
00.
04.
0W
ondf
o On
e St
ep M
alar
ia P
.f Te
st
W 3
7-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.5.
00.
04.
05.
00.
03.
85.
00.
04.
05.
00.
04.
05.
00.
03.
65.
00.
04.
05.
00.
04.
05.
00.
04.
0Pf
and
Pan
ABON
™ P
lus
Mal
aria
P.f/
Pan
Rapi
d Te
st D
evic
e (W
hole
Blo
od)
IMA-
T402
ABON
Bio
phar
m (H
angz
hou)
Co.
Ltd
5.0
0.0
4.0
5.0
0.0
3.6
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
3.0
5.0
0.0
3.4
5.0
0.0
4.0
AZOG
Mal
aria
pf
(HRP
II)/p
f (L
DH)/
(PAN
-LDH
) An
tigen
Det
ectio
n De
vice
cM
FV-1
24F
AZOG
, IN
C.5.
00.
03.
05.
00.
03.
05.
00.
02.
85.
00.
03.
65.
00.
03.
05.
00.
03.
05.
00.
03.
05.
00.
03.
0
AZOG
Mal
aria
pf
(HRP
II)/p
f (L
DH)/
(PAN
-LDH
) An
tigen
Det
ectio
n De
vice
dM
FV-1
24F
AZOG
, IN
C.1.
00.
01.
04.
00.
01.
01.
00.
01.
00.
00.
00.
00.
00.
00.
05.
00.
01.
05.
00.
01.
05.
00.
01.
0
Core
Mal
aria
Pan
Pf
MAL
-190
024
Core
Dia
gnos
tics
Ltd.
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
EzDx
™ M
alar
ia P
an/P
f Rap
id T
est D
etec
tion
kit
RK M
AL 0
01Ad
vy C
hem
ical
(Aff
iliat
e of
Bha
rat
Seru
ms
& V
acci
nes
Ltd.
)5.
00.
03.
65.
00.
04.
05.
00.
03.
85.
00.
03.
85.
00.
03.
65.
00.
04.
05.
00.
04.
05.
00.
04.
0
Firs
tSig
n™ P
araV
iew
(Pan
+Pf)
2101
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
Hum
asis
Mal
aria
P.f/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is, C
o., L
td.
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
3.8
5.0
0.0
3.4
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
ICT
MAL
ARIA
COM
BOM
L02
ICT
INTE
RNAT
ION
AL5.
00.
03.
85.
00.
04.
05.
00.
03.
25.
00.
03.
65.
00.
03.
05.
00.
02.
85.
00.
03.
65.
00.
03.
6IN
D ON
E ST
EP M
ALAR
IA A
NTI
GEN
P.f/
Pan
TEST
535-
10IN
D Di
agno
stic
s In
c.5.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
0
Mal
aria
Pf/
PAN
GM
004
Gen
omix
Mol
ecul
ar D
iagn
osti
cs
Pvt.L
td.
5.0
0.0
2.8
5.0
0.0
3.2
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
1.8
5.0
0.0
2.8
5.0
0.0
3.0
Mal
aria
pf (
HRP
II)/P
AN (p
LDH)
Ant
igen
Det
ectio
n Te
st D
evic
e1-
13-1
01-1
Uni
ted
Biot
ech,
Inc.
5.
00.
02.
85.
00.
03.
05.
00.
03.
25.
00.
03.
25.
00.
02.
85.
00.
02.
85.
00.
03.
05.
00.
03.
0
Mal
eris
can®
Mal
aria
P.f/
PAN
(Pv,
Pm, P
o) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PA
N-
50Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
5.0
0.0
4.0
5.0
0.0
3.8
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
3.8
5.0
0.0
3.0
5.0
0.0
3.0
MeD
iPro
Mal
aria
Ag
HRP
2/pL
DH C
ombo
IR-0
051K
Form
osa
Biom
edica
l Tec
hnol
ogy C
orp.
5.0
0.0
3.0
5.0
0.0
2.8
5.0
0.0
2.6
5.0
0.0
2.2
5.0
0.0
2.6
5.0
0.0
2.0
5.0
0.0
3.0
5.0
0.0
2.8
Nan
oSig
n M
alar
ia p
f/pa
n Ag
3.0
RMAP
10Bi
olan
d Lt
d.5.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
0On
Site
Pf/
Pan
Ag R
apid
Tes
tR0
113C
CTK
Biot
ech,
Inc.
5.0
0.0
3.0
5.0
0.0
3.0
5.0
0.0
3.0
5.0
0.0
3.0
5.0
0.0
2.4
5.0
0.0
3.0
5.0
0.0
3.0
5.0
0.0
3.0
Para
HIT
- T
otal
Ver
. 1.0
(Dip
stic
k)55
IC20
3-10
Span
Dia
gnos
tics
Ltd.
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
4.0
1.0
2.3
2.0
2.0
3.5
5.0
0.0
4.0
5.0
0.0
4.0
Para
HIT
- T
otal
Ver
. 1.0
(Dev
ice)
55IC
204-
10Sp
an D
iagn
ostic
s Lt
d.5.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
0Pa
rasc
reen
® -
Rapi
d te
st fo
r Mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
edic
als
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 111
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35°C
45°C
4°C
Lot
1 (n
=5)
Lot
2 (n
=5)
Lot
1 (n
=5)
Lot
2 (n
=5)
Lot
1 (n
=5)
Lot
2 (n
=5)
Lot
1 (n
=5)
Lot
2 (n
=5)
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
an05
FK66
Stan
dard
Dia
gnos
tics
Inc.
5.
00.
04.
04.
01.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
0Pf
and
Pv
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/P
v) C
OMBO
G01
61Ac
cess
Bio
, Inc
.5.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
0Ca
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/VOM
) COM
BOG
0171
Acce
ss B
io, I
nc.
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
Falc
iVax
™ -
Rap
id te
st fo
r Mal
aria
Pv/
Pf
5030
0025
Zeph
yr B
iom
edic
als
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
HiS
ens
Mal
aria
Ag
P.f/
P.v
Com
bo C
ard
HR3
123
HBI
Co.
, Ltd
.5.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
0H
iSen
s M
alar
ia A
g P.
f/VO
M C
ombo
Car
dH
R332
3H
BI C
o., L
td.
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
Hum
asis
Mal
aria
P.f/
P.v
Antig
en T
est
AMFV
-702
5H
umas
is, C
o., L
td.
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
3.8
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
Mal
aria
Pf/
PvG
M00
2G
enom
ix M
olec
ular
Dia
gnos
tics
Pv
t.Ltd
.5.
00.
03.
05.
00.
03.
25.
00.
02.
05.
00.
02.
05.
00.
02.
05.
00.
02.
05.
00.
03.
05.
00.
03.
0
Mal
aria
pf (
HRP
II) /
pv (p
LDH)
Ant
igen
Det
ectio
n Te
st D
evic
e1-
13-1
01-3
Uni
ted
Biot
ech,
Inc.
4.
00.
03.
85.
00.
03.
25.
00.
03.
65.
00.
03.
25.
00.
02.
85.
00.
02.
85.
00.
03.
05.
00.
03.
0
Med
isens
or M
alar
ia H
RP2/
pLDH
(Pf/P
v) C
OMBO
M16
1M
edis
enso
r, In
c.5.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
0M
edise
nsor
Mal
aria
HRP
2/pL
DH (P
f/VOM
) COM
BOM
171
Med
isen
sor,
Inc.
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
52Bl
ue C
ross
Bio
-Med
ical
(Be
ijing
) Co
., Lt
d.5.
00.
02.
05.
00.
02.
05.
00.
01.
05.
00.
01.
45.
00.
01.
04.
00.
00.
85.
00.
02.
05.
00.
01.
8
OnSi
te P
f/Pv
Ag
Rapi
d Te
stR0
112C
CTK
Biot
ech,
Inc.
5.0
0.0
3.2
5.0
0.0
3.8
5.0
0.0
4.0
5.0
0.0
3.0
5.0
0.0
3.2
5.0
0.0
2.8
5.0
0.0
3.4
5.0
0.0
3.4
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOG
0161
Acce
ss B
io E
thio
pia
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/VOM
) COM
BOG
0171
Acce
ss B
io E
thio
pia
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
RAPI
D 1-
2-3®
HEM
A CA
SSET
TE M
ALAR
IA P
F/PV
TES
TM
AL-P
FV-
CAS/
25(1
00)
Hem
a Di
agno
stic
Sys
tem
s, LL
C5.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
0
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
vc05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
vd05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
5.0
0.0
1.6
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
2.0
5.0
0.0
1.4
Trus
ty™
Mal
aria
Ant
igen
P.f.
/p.v.
test
A03-
12-3
22Ar
tron
Lab
orat
orie
s In
c.5.
00.
03.
05.
00.
03.
05.
00.
03.
05.
00.
02.
65.
00.
02.
05.
00.
01.
45.
00.
03.
05.
00.
03.
2Pa
n on
lyAZ
OG h
CG M
alar
ia D
etec
tion
Test
Dev
ice
MPT
-124
AZOG
, IN
C.5.
00.
04.
05.
00.
03.
05.
00.
03.
05.
00.
03.
45.
00.
00.
85.
00.
01.
05.
00.
03.
05.
00.
03.
4
ND,
not
det
erm
ined
Pf, P
lasm
odiu
m fa
lcip
arum
P
v, Pl
asm
odiu
m v
ivax
p
an, P
lasm
odiu
m sp
ecie
sa
For p
an-o
nly
test
sb
Posi
tive
resu
lts p
rese
nted
in th
e ta
ble
are
base
d on
sta
bilit
y of
a p
ositi
ve re
ader
1 o
r rea
der 2
resu
ltc
Resu
lts p
rese
nted
in
the
tabl
e ar
e ba
sed
on b
and
inte
nsity
of a
pf-
HRP
2 lin
ed
Resu
lts p
rese
nted
in
the
tabl
e ar
e ba
sed
on b
and
inte
nsity
of a
pf-
pLDH
line
Tabl
e A
4.12
(co
ntin
ued)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)112
Tabl
e A
4.12
a: H
eat
stab
ility
tes
ting
resu
lts
for
pan
test
line
of
com
bina
tion
RDTs
on
a P.
fal
cipa
rum
sam
ple
at h
igh
para
site
den
sity
(20
00 p
aras
ites
/µl)
. Po
siti
vity
rat
e at
bas
elin
e, a
nd a
fter
60
days
incu
batio
n at
4°C
, 35°
C an
d 45
°C
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35°C
45°C
4°C
Lot
1 (n
=5)
Lot
2 (n
=5)
Lot
1 (n
=5)
Lot
2 (n
=5)
Lot
1 (n
=5)
Lot
2 (n
=5)
Lot
1 (n
=5)
Lot
2 (n
=5)
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
Pf a
nd P
anAB
ON™
Plu
s M
alar
ia P
.f/Pa
n Ra
pid
Test
Dev
ice
(Who
le B
lood
)IM
A-T4
02AB
ON B
ioph
arm
(Han
gzho
u) C
o. Lt
d0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
AZOG
Mal
aria
pf
(HRP
II)/p
f (L
DH)/
(PAN
-LDH
) An
tigen
Det
ectio
n De
vice
M
FV-1
24F
AZOG
, IN
C.0.
00.
00.
02.
00.
01.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
05.
00.
01.
00.
00.
00.
0
Core
Mal
aria
Pan
Pf
MAL
-190
024
Core
Dia
gnos
tics
Ltd.
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
2.0
EzDx
™ M
alar
ia P
an/P
f Rap
id T
est D
etec
tion
kit
RK M
AL 0
01Ad
vy C
hem
ical
(Aff
iliat
e of
Bha
rat
Seru
ms
& V
acci
nes
Ltd.
)5.
00.
01.
05.
00.
01.
05.
00.
01.
05.
00.
01.
03.
00.
01.
04.
00.
01.
05.
00.
01.
05.
00.
01.
0
Firs
tSig
n™ P
araV
iew
(Pan
+Pf)
2101
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
5.0
0.0
1.2
5.0
0.0
1.0
5.0
0.0
2.0
5.0
0.0
1.2
5.0
0.0
1.2
5.0
0.0
2.0
5.0
0.0
1.8
5.0
0.0
1.4
Hum
asis
Mal
aria
P.f/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is, C
o., L
td.
5.0
0.0
1.8
5.0
0.0
1.0
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
1.4
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
2.0
ICT
MAL
ARIA
COM
BOM
L02
ICT
INTE
RNAT
ION
AL5.
00.
01.
05.
00.
01.
02.
00.
01.
03.
00.
01.
04.
00.
01.
03.
00.
01.
03.
00.
01.
02.
00.
01.
0IN
D ON
E ST
EP M
ALAR
IA A
NTI
GEN
P.f/
Pan
TEST
535-
10IN
D Di
agno
stic
s In
c.5.
00.
01.
65.
00.
01.
85.
00.
02.
05.
00.
02.
05.
00.
01.
45.
00.
01.
65.
00.
01.
25.
00.
01.
0
Mal
aria
Pf/
PAN
GM
004
Gen
omix
Mol
ecul
ar D
iagn
osti
cs
Pvt.L
td.
1.0
0.0
1.0
5.0
0.0
1.0
4.0
0.0
1.0
5.0
0.0
1.0
0.0
0.0
0.0
5.0
0.0
1.0
5.0
0.0
1.0
0.0
0.0
0.0
Mal
aria
pf (
HRP
II)/P
AN (p
LDH)
Ant
igen
Det
ectio
n Te
st D
evic
e1-
13-1
01-1
Uni
ted
Biot
ech,
Inc.
4.
00.
01.
05.
00.
01.
00.
00.
00.
04.
00.
01.
05.
00.
01.
00.
00.
00.
05.
00.
01.
05.
00.
01.
0
Mal
eris
can®
Mal
aria
P.f/
PAN
(Pv,
Pm, P
o) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PA
N-
50Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
MeD
iPro
Mal
aria
Ag
HRP
2/pL
DH C
ombo
IR-0
051K
Form
osa
Biom
edica
l Tec
hnol
ogy C
orp.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Nan
oSig
n M
alar
ia p
f/pa
n Ag
3.0
RMAP
10Bi
olan
d Lt
d.5.
00.
01.
05.
00.
01.
85.
00.
02.
05.
00.
01.
85.
00.
01.
85.
00.
02.
05.
00.
02.
05.
00.
01.
0On
Site
Pf/
Pan
Ag R
apid
Tes
tR0
113C
CTK
Biot
ech,
Inc.
5.0
0.0
1.0
2.0
0.0
1.0
0.0
0.0
0.0
2.0
0.0
1.0
1.0
0.0
1.0
0.0
0.0
0.0
0.0
0.0
0.0
2.0
0.0
1.0
Para
HIT
- T
otal
Ver
. 1.0
(Dip
stic
k)55
IC20
3-10
Span
Dia
gnos
tics
Ltd.
5.0
0.0
1.0
5.0
0.0
1.0
4.0
0.0
1.0
5.0
0.0
1.0
0.0
1.0
0.0
0.0
2.0
0.0
5.0
0.0
1.0
5.0
0.0
1.0
Para
HIT
- T
otal
Ver
. 1.0
(Dev
ice)
55IC
204-
10Sp
an D
iagn
ostic
s Lt
d.5.
00.
01.
05.
00.
01.
05.
00.
01.
05.
00.
01.
05.
00.
01.
05.
00.
01.
05.
00.
01.
45.
00.
01.
0Pa
rasc
reen
® -
Rapi
d te
st fo
r Mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
edic
als
5.0
0.0
1.8
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
2.0
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
an05
FK66
Stan
dard
Dia
gnos
tics
Inc.
5.
00.
01.
04.
01.
02.
05.
00.
02.
05.
00.
02.
05.
00.
02.
05.
00.
02.
05.
00.
02.
05.
00.
02.
0Pf
and
Pv
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/P
v) C
OMBO
G01
61Ac
cess
Bio
, Inc
.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
ACa
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/VOM
) COM
BOG0
171
Acce
ss B
io, I
nc.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Falc
iVax
™ -
Rap
id te
st fo
r Mal
aria
Pv/
Pf
5030
0025
Zeph
yr B
iom
edic
als
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
HiS
ens
Mal
aria
Ag
P.f/
P.v
Com
bo C
ard
HR31
23H
BI C
o., L
td.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
HiS
ens
Mal
aria
Ag
P.f/
VOM
Com
bo C
ard
HR33
23H
BI C
o., L
td.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Hum
asis
Mal
aria
P.f/
P.v
Antig
en T
est
AMFV
-702
5H
umas
is, C
o., L
td.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
aria
Pf/
PvGM
002
Gen
omix
Mol
ecul
ar D
iagn
osti
cs
Pvt.L
td.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
aria
pf (
HRP
II) /
pv (p
LDH)
Ant
igen
Det
ectio
n Te
st D
evic
e1-
13-1
01-3
Uni
ted
Biot
ech,
Inc.
N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Med
isens
or M
alar
ia H
RP2/
pLDH
(Pf/P
v) C
OMBO
M16
1M
edis
enso
r, In
c.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AM
edise
nsor
Mal
aria
HRP
2/pL
DH (P
f/VOM
) COM
BOM
171
Med
isen
sor,
Inc.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
52Bl
ue C
ross
Bio
-Med
ical
(Be
ijing
) Co
., Lt
d.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 113
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35°C
45°C
4°C
Lot
1 (n
=5)
Lot
2 (n
=5)
Lot
1 (n
=5)
Lot
2 (n
=5)
Lot
1 (n
=5)
Lot
2 (n
=5)
Lot
1 (n
=5)
Lot
2 (n
=5)
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
OnSi
te P
f/Pv
Ag
Rapi
d Te
stR0
112C
CTK
Biot
ech,
Inc.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOG0
161
Acce
ss B
io E
thio
pia
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/VOM
) COM
BOG0
171
Acce
ss B
io E
thio
pia
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
RAPI
D 1-
2-3®
HEM
A CA
SSET
TE M
ALAR
IA P
F/PV
TES
TM
AL-P
FV-
CAS/
25(1
00)
Hem
a Di
agno
stic
Sys
tem
s, LL
CN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
v05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Trus
ty™
Mal
aria
Ant
igen
P.f.
/p.v.
test
A03-
12-3
22Ar
tron
Lab
orat
orie
s In
c.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
a Po
sitiv
e re
sults
pre
sent
ed in
the
tabl
e ar
e ba
sed
on s
tabi
lity
of a
pos
itive
read
er 1
or r
eade
r 2 re
sult
Tabl
e A
4.12
a (c
ontin
ued)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)114
Tabl
e A
4.13
: Hea
t st
abili
ty t
estin
g re
sult
s fo
r P.
fal
cipa
rum
(or
pan
) te
st li
ne o
n pa
rasi
te n
egat
ive
sam
ples
. Pos
itivi
ty r
ate
at b
asel
ine,
and
aft
er 6
0 da
ys in
cuba
tion
at 4
°C, 3
5°C
and
45°C
b
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35°C
45°C
4°C
Lot
1 (n
=4)
Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
=4)
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
Pf o
nly
ABON
™ M
alar
ia P
.f. R
apid
Test
Dev
ice
(Who
le B
lood
)IM
A-40
2AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0BI
OCRE
DIT
Mal
aria
pf(H
RP II
)H
R010
0Ra
piG
en In
c.4.
00.
04.
00.
04.
00.
04.
00.
04.
00.
04.
00.
04.
00.
04.
00.
0Fi
rstS
ign™
Mal
aria
Pf
2100
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN P
.f 53
5-11
IND
Diag
nost
ics
Inc.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Mal
eris
can
® M
alar
ia P
.f An
tigen
Tes
tM
AT-P
F-50
Bhat
Bio
-Tec
h In
dia
(Pte
.) Lt
d.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0On
e St
ep M
alar
ia P
.F T
est (
Cass
ette
)52
2352
Blue
Cro
ss B
io-M
edic
al (B
eijin
g) C
o., L
td.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipa
rum
Mal
aria
De
vice
(Ver
.3)
3030
1025
Orch
id B
iom
edic
al S
yste
ms
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipa
rum
Mal
aria
Di
pstic
k (V
er.3
)30
3020
25Or
chid
Bio
med
ical
Sys
tem
s 0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Trus
ty™
Mal
aria
Ant
igen
P.f.
test
A03-
11-3
22Ar
tron
Lab
orat
orie
s In
c.3.
00.
04.
00.
01.
00.
00.
00.
00.
00.
00.
00.
04.
00.
04.
00.
0W
ondf
o On
e St
ep M
alar
ia P
.f Te
st
W 3
7-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0Pf
and
Pan
ABO
N™
Plu
s M
alar
ia P
.f/Pa
n Ra
pid
Test
Dev
ice
(Who
le B
lood
)IM
A-T4
02AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
AZOG
Mal
aria
pf (
HRPI
I)/pf
(LDH
)/ (P
AN-L
DH) A
ntig
en
Dete
ctio
n De
vice
cM
FV-1
24F
AZOG
, IN
C.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
01.
00.
0
AZOG
Mal
aria
pf (
HRPI
I)/pf
(LDH
)/ (P
AN-L
DH) A
ntig
en
Dete
ctio
n De
vice
dM
FV-1
24F
AZOG
, IN
C.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Core
Mal
aria
Pan
Pf
MAL
-190
024
Core
Dia
gnos
tics
Ltd.
0.0
0.0
2.0
0.0
0.0
0.0
4.0
0.0
4.0
0.0
4.0
0.0
0.0
0.0
4.0
0.0
EzDx
™ M
alar
ia P
an/P
f Rap
id T
est D
etec
tion
kit
RK M
AL 0
01Ad
vy C
hem
ical
(Aff
iliat
e of
Bha
rat S
erum
s &
Vac
cine
s Lt
d. )
0.0
0.0
1.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
1.0
0.0
0.0
0.0
Firs
tSig
n™ P
araV
iew
(Pan
+Pf)
2101
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Hum
asis
Mal
aria
P.f/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is, C
o., L
td.
4.0
0.0
4.0
0.0
4.0
0.0
4.0
0.0
4.0
0.0
4.0
0.0
4.0
0.0
4.0
0.0
ICT
MAL
ARIA
COM
BOM
L02
ICT
INTE
RNAT
ION
AL0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0IN
D ON
E ST
EP M
ALAR
IA A
NTI
GEN
P.f/
Pan
TEST
535-
10IN
D Di
agno
stic
s In
c.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0M
alar
ia P
f/ P
ANG
M00
4G
enom
ix M
olec
ular
Dia
gnos
tics
Pvt.L
td.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Mal
aria
pf (
HRP
II)/P
AN (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e1-
13-1
01-1
Uni
ted
Biot
ech,
Inc.
0.
00.
01.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Mal
eris
can®
Mal
aria
P.f/
PAN
(Pv,
Pm, P
o) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PA
N-5
0Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
MeD
iPro
Mal
aria
Ag
HRP
2/pL
DH C
ombo
IR-0
051K
Form
osa
Biom
edic
al T
echn
olog
y Co
rp.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Nan
oSig
n M
alar
ia p
f/pa
n Ag
3.0
RMAP
10Bi
olan
d Lt
d.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0On
Site
Pf/
Pan
Ag R
apid
Tes
tR0
113C
CTK
Biot
ech,
Inc.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
2.0
0.0
0.0
0.0
0.0
0.0
Para
HIT
- T
otal
Ver
. 1.0
(Dip
stic
k)55
IC20
3-10
Span
Dia
gnos
tics
Ltd.
0.0
0.0
4.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Para
HIT
- T
otal
Ver
. 1.0
(Dev
ice)
55IC
204-
10Sp
an D
iagn
ostic
s Lt
d.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0Pa
rasc
reen
® -
Rapi
d te
st fo
r Mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
edic
als
4.0
0.0
4.0
0.0
2.0
0.0
4.0
0.0
4.0
0.0
4.0
0.0
4.0
0.0
4.0
0.0
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
an05
FK66
Stan
dard
Dia
gnos
tics
Inc.
0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0Pf
and
Pv
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/
Pv) C
OMBO
G01
61Ac
cess
Bio
, Inc
.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0Ca
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/VO
M) C
OMBO
G01
71Ac
cess
Bio
, Inc
.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 115
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35°C
45°C
4°C
Lot
1 (n
=4)
Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
=4)
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
Falc
iVax
™ -
Rap
id te
st fo
r Mal
aria
Pv/
Pf
5030
0025
Zeph
yr B
iom
edic
als
0.0
0.0
0.0
0.0
0.0
0.0
3.0
0.0
3.0
0.0
0.0
0.0
4.0
0.0
0.0
0.0
HiS
ens
Mal
aria
Ag
P.f/
P.v
Com
bo C
ard
HR3
123
HBI
Co.
, Ltd
.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0H
iSen
s M
alar
ia A
g P.
f/VO
M C
ombo
Car
dH
R332
3H
BI C
o., L
td.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Hum
asis
Mal
aria
P.f/
P.v
Antig
en T
est
AMFV
-702
5H
umas
is, C
o., L
td.
0.0
0.0
0.0
0.0
4.0
0.0
2.0
0.0
4.0
0.0
4.0
0.0
0.0
0.0
0.0
0.0
Mal
aria
Pf/
PvG
M00
2G
enom
ix M
olec
ular
Dia
gnos
tics
Pvt.L
td.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Mal
aria
pf
(HRP
II) /
pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
1-13
-101
-3U
nite
d Bi
otec
h, In
c.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Med
isen
sor M
alar
ia H
RP2/
pLDH
(Pf/
Pv) C
OMBO
M16
1M
edis
enso
r, In
c.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0M
edis
enso
r Mal
aria
HRP
2/pL
DH (P
f/VO
M) C
OMBO
M17
1M
edis
enso
r, In
c.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0On
e St
ep M
alar
ia P
.F/P
.V T
est (
Cass
ette
)52
3352
Blue
Cro
ss B
io-M
edic
al (B
eijin
g) C
o., L
td.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
OnSi
te P
f/Pv
Ag
Rapi
d Te
stR0
112C
CTK
Biot
ech,
Inc.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
2.0
0.0
0.0
0.0
0.0
0.0
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOG
0161
Acce
ss B
io E
thio
pia
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/VO
M) C
OMBO
G01
71Ac
cess
Bio
Eth
iopi
a0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
RAPI
D 1-
2-3®
HEM
A CA
SSET
TE M
ALAR
IA P
F/PV
TEST
MA
L-
PF
V-
CAS/
25(1
00)
Hem
a Di
agno
stic
Sys
tem
s, LL
C0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
vc05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
vd05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Trus
ty™
Mal
aria
Ant
igen
P.f.
/p.v.
test
A03-
12-3
22Ar
tron
Lab
orat
orie
s In
c.3.
00.
04.
00.
04.
00.
01.
00.
00.
00.
00.
00.
04.
00.
04.
00.
0Pa
n on
lyAZ
OG h
CG M
alar
ia D
etec
tion
Test
Dev
ice
MPT
-124
AZOG
, INC
.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
02.
00.
00.
00.
0
Pf, P
lasm
odiu
m fa
lcip
arum
P
v, Pl
asm
odiu
m v
ivax
p
an, P
lasm
odiu
m sp
ecie
sa
For p
an-o
nly
test
sb
Posi
tive
resu
lts p
rese
nted
in th
e ta
ble
are
base
d on
sta
bilit
y of
a p
ositi
ve re
ader
1 o
r rea
der 2
resu
ltc
Resu
lts p
rese
nted
in
the
tabl
e ar
e ba
sed
on b
and
inte
nsity
of a
pf-
HRP
2 lin
ed
Resu
lts p
rese
nted
in
the
tabl
e ar
e ba
sed
on b
and
inte
nsity
of a
pf-
pLDH
line
Tabl
e A
4.13
(co
ntin
ued)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)116
Tabl
e A
4.13
a: H
eat
stab
ility
tes
ting
resu
lts
for
pan
test
line
of
com
bina
tion
RDTs
on
para
site
neg
ativ
e sa
mpl
es. P
ositi
vity
rat
e at
bas
elin
e, a
nd a
fter
60
days
incu
batio
n at
4°C
, 35°
C an
d 45
°C
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35°C
45°C
4°C
Lot
1 (n
=4)
Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
=4)
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
Pf a
nd P
an
ABO
N™
Plu
s M
alar
ia P
.f/Pa
n Ra
pid
Test
Dev
ice
(Who
le B
lood
)IM
A-T4
02AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
01.
00.
00.
00.
00.
00.
0
AZOG
Mal
aria
pf (
HRPI
I)/pf
(LDH
)/ (P
AN-L
DH) A
ntig
en
Dete
ctio
n De
vice
M
FV-1
24F
AZOG
, IN
C.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Core
Mal
aria
Pan
Pf
MAL
-190
024
Core
Dia
gnos
tics
Ltd.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
EzDx
™ M
alar
ia P
an/P
f Rap
id T
est D
etec
tion
kit
RK M
AL 0
01Ad
vy C
hem
ical
(Aff
iliat
e of
Bha
rat S
erum
s &
Vac
cine
s Lt
d. )
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Firs
tSig
n™ P
araV
iew
(Pan
+Pf)
2101
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Hum
asis
Mal
aria
P.f/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is, C
o., L
td.
4.0
0.0
4.0
0.0
4.0
0.0
4.0
0.0
4.0
0.0
4.0
0.0
4.0
0.0
4.0
0.0
ICT
MAL
ARIA
COM
BOM
L02
ICT
INTE
RNAT
ION
AL0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN P
.f/Pa
n TE
ST53
5-10
IND
Diag
nost
ics
Inc.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Mal
aria
Pf/
PAN
GM
004
Gen
omix
Mol
ecul
ar D
iagn
ostic
s Pv
t.Ltd
.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Mal
aria
pf
(HRP
II)/P
AN (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e1-
13-1
01-1
Uni
ted
Biot
ech,
Inc.
0.
00.
01.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Mal
eris
can®
Mal
aria
P.f/
PAN
(Pv
, Pm
, Po)
3 L
ine
Antig
en T
est
MAT
-PF/
PAN
-50
Bhat
Bio
-Tec
h In
dia
(Pte
.) Lt
d.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
MeD
iPro
Mal
aria
Ag
HRP
2/pL
DH C
ombo
IR-0
051K
Form
osa
Biom
edic
al T
echn
olog
y Co
rp.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Nan
oSig
n M
alar
ia p
f/pa
n Ag
3.0
RMAP
10Bi
olan
d Lt
d.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
OnSi
te P
f/Pa
n Ag
Rap
id T
est
R011
3CCT
K Bi
otec
h, In
c.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Para
HIT
- T
otal
Ver
. 1.0
(Dip
stic
k)55
IC20
3-10
Span
Dia
gnos
tics
Ltd.
0.0
0.0
3.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Para
HIT
- T
otal
Ver
. 1.0
(Dev
ice)
55IC
204-
10Sp
an D
iagn
ostic
s Lt
d.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Para
scre
en®
- Ra
pid
test
for M
alar
ia P
an/P
f50
3100
25Ze
phyr
Bio
med
ical
s0.
00.
00.
00.
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Pf a
nd P
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A
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ss B
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HiS
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Mal
aria
Ag
P.f/
P.v
Com
bo C
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123
HBI
Co.
, Ltd
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AN
AN
AN
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A
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Ag
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AN
A
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asis
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aria
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en T
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td.
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Mal
aria
Pf/
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td.
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NA
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Med
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sor M
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Med
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(Pf/
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Inc.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 117
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
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ue C
ross
Bio
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(Bei
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Para
Care
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f/Pv
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NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
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NA
Para
Care
Mal
aria
HRP
2/pL
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f/VO
M) C
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cess
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Eth
iopi
aN
AN
AN
AN
AN
AN
AN
AN
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AN
AN
AN
AN
AN
AN
AN
A
RAPI
D 1-
2-3®
HEM
A CA
SSET
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ALAR
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00)
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a Di
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tem
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CN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
v05
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0St
anda
rd D
iagn
ostic
s In
c.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Trus
ty™
Mal
aria
Ant
igen
P.f.
/p.v.
test
A03-
12-3
22Ar
tron
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orat
orie
s In
c.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
a Po
sitiv
e re
sults
pre
sent
ed in
the
tabl
e ar
e ba
sed
on s
tabi
lity
of a
pos
itive
read
er 1
or r
eade
r 2 re
sult
Tabl
e A
4.13
a (c
ontin
ued)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)118
Figure A5.1 How to select of an appropriate RDT
Step 1.1Definesettingofuse
What ?targetparasitespeciesandantigena
Pf or mixed Pf/non-Pf infections:- HRP2- pLDH-Pf
Pf or non-Pf infectionsb:- HRP2, aldolase ; HRP2, pLDH-pan- HRP2, pLDH-Pv; HRP2, pLDH-Pvom- HRP2, pLDH-pan; pLDH-Pv- pLDH-Pf, pLDH-pan; pLDH-Pf, pLDH-Pv- pLDH-Pf, pLDH-P vom
P.vivax, only:- aldolase- pLDH-pan- pLDH-Pv
**Pf with absent HRP2–DONOTUSEHRP2basedRDTsc
Where ? Exposurehightemperatureeg.tropicalenvironmentORTemperaturecontrolledenvironment,includingduringtransportandstorage
Who? LaboratorypersonnelORHealthworkersoutsideoflaboratories
Step 1.2Review RDT performance
WHO RDT Product Testing resultsdandapplyWHOrecommendedRDTselectioncriteriae
- Panel Detection Score (PDS)- False Positivity Rate (FPR)- Invalid Rate (IR)- Ease of use- Thermal stability- Ease of use
Sensitivity and specificity based on quality field studies in relevant populations
Generate RDT short list
Step 1.3Apply national guidelines and experience in use of RDTs
National malaria treatment guidelines
In-country experience: ease of use assessments (Annex 5b); availability of training materials
Step 1.4Other considerations
- Price- Supplier’s: production capacity, lead times, heat stability data- Delivery schedules (eg. staggered deliveries), box size, shelf life- Registration requirements of a national regulatory authorities- Product lot testing results- Overall budget requirements (Annex 6)
a Pf only or mixed Pf/non Pf infections: Most area of sub-Saharan Africa and lowland Papua New Guinea; : Pf and non-Pf invfections (single species): Most endemic areas of Asia and the Americas and isolated areas of the Horn of Africa; Mainly vivax-only: areas of East Asia, central Asia, South America, and some highland areas elsewhere
b Tests with a falciparum-specific line and pan-specific line will not distinguish P. falciparum-only infections from mixed falciparum infections. Distinguishing falciparum from mixed falciparum-vivax infections only becomes important if a full course of primaquine is routinely given for infections due to P. vivax. This must be weighed against the loss of ability to detect P. malariae and P. ovale if a test has only P. falciparum and P. vivax-specific lines. Inclusion of further test lines to detect these (eg. Pf-Pv-pan) increases complexity of test interpretation. A programme should prioritize these various advantages and dis-advantages according to local conditions in the initial stage of making procurement decisions.
c P. falciparum parasites lacking HRP2 +/- HRP3 genes have been identified in parts of South America (Gamboa D et al. PLoS ONE 5(1):e8091.doi:10.1371/journal.pone.000809)d Malaria Rapid Diagnostic Test Performance: Results of WHO product testing of malaria RDTs: Round 1(2008); Round 2 (2009); Round 3 (2011); Round 4 (2012); FIND Malaria
RDT Product Testing: Interactive Guide - http://www.finddiagnostics.org/programs/malaria-afs/malaria/rdt_quality_control/product_testing/interactive-guide/index.jspe WHO RDT procurement criteria : http://www.who.int/malaria/diagnosis_treatment/diagnosis/en/index.html
ForacomprehensiveguidetoprocurementofmalariaRDTsextendingbeyondselectiontoquantification,budgeting,technicalspecifications,managementoftenders,contracts,supplymanagementandmonitoringofsupplierperformanceandmanagingproductvariations,seethe“GoodPracticesforselectingandprocuringrapiddiagnostictestsformalaria”(6)
annex 5a: selection of an appropriate rdt
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 119
annex 5b: Malaria rdt field assessment and rdt anomaliesObtainsamplesofeachmalariaRDTunderconsideration(atleastoneboxpackagedasintendedfordeliverytoendusers.)
Obtainmalariaparasite-negativebloodsamples,andwherereadilyaccessible,parasite-positivebloodsamplesfortestingagainstRDTs.Thepurposeofthisevaluation,onalimitednumberofRDTs,istoassessaspectsofpackaging,safetyandease-of-use,and not to assess diagnostic accuracy.
Table A5.1 Field assessment of RDT packaging, safety and ease-of-use to guide product selection
Date of assessment Name of RDT
Yes No NA Problems /CommentsPackaging and accessories
The RDT box is in good conditionRDTs are in individual sealed packages
The correct number of RDTs are in the boxA desiccant is included
An expiry date is visible on the packageAll required accessories are included (test, buffer, blood transfer
device, alcohol swab, lancet, gloves, test tubes (for dipsticks)) If no, what is not included:
InstructionsInstructions are included
Instructions are in the national language(s)The instructions are for the correct product
The instructions include diagrams The diagrams are accurate (specifically order of test lines
and results interpretation)
Preparation and ProcedureIt is easy to write on the test device
It is easy to open the test pouchThe test lines on the device are clearly labelledIt is easy to use the device for blood collection
It is easy to open the buffer bottleThe buffer bottle dispenses even drops
It is easy to fill the sample well correctly with the provided blood transfer device
It is easy to fill the buffer well correctly (no overflow)The buffer flows well through the test strip
Result InterpretationControl and test lines
Control line is clearTest line(s) are clear
Good clearance of blood by time of reading If no, number of tests in the box affected:
Steps and reading time Reading time <30 minsTwo or less timed steps
Did you get 1 or more invalid tests (no control line) among the last 10 tests you performed?
If YES, how many?
SafetyAre there mixing wells (risk of blood splash)?
Retractable needle for finger prick?Is the RDT strip exposed eg. dipstick test format?
Do you have any safety problems/concerns regarding the waste disposal? (Please describe)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)120
Figure A5.2 Malaria RDT anomalies encountered in production lots
BelowareexamplesofRDTanomaliesencounteredduringWHOMalariaRDTProductTestingattheCDC.Sincemid-2012,WHO-FINDLotTestinglaboratoriesarereportingtheseanomaliestorequesters1.Inmostcases,theseanomaliesdonotinvalidatetheresults,asreactivityinthecontrolandtestlineareasarestillvisible,buttheymayposechallengestohealthworkersinterpretingtheresults.Furthermore,theyshouldbereportedtomanufacturers.
A – Red background (residual blood smear that could obscure test and control lines)
B - Incomplete clearing with residual streaking blood
Notes: Poor clearing of blood may obscure weak positive test lines, causing false negative results. Faint background staining is relatively common, and should only be commented on if intensity is significant, similar to the pictures shown. If a test line is visible despite blood streaking, the test result should be reported as ‘positive’.
C – Failure to Flow
Bloodandbufferdidnotrunthelengthofthestrip
D - Ghost test lines
Note: White lines appear on a blood-stained background. Ghost lines do not indicate a positive test result; positive test lines are those that are darker than the strip’s background color.
1 http://www.finddiagnostics.org/export/sites/default/programs/malaria-afs/docs/lot_testing/Malaria_RDT_functional_anomalies.pdf(accessed31October2012)
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 121
E – Patchy or broken test line(s)
F - Faint test line(s)
G - Diffuse test line(s)
Note: Test line appears wider than control line, without clearly defined edge.
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)122
Asparasite-baseddiagnosisisintroducedatsmallerclinicsandvillagelevelforcasemanagement,alargenumberofchallengesarisenotonlyinlogisticaladministrationbutalsoinmanagingthehealth-seekingandhealth-providingbehaviourofpatientsandhealthworkers.Thesecanbeaddressedbyaclear,time-boundstrategicplanthatspansplanning,implementation,monitoringandevaluationofthediagnosticprogramme;aprocessthatmustcommencewellbeforeRDTsareprocured.Furthermore,fundingfortheprogrammemustincludeasignificantcomponentforplan-ningandcoordination,sensitization/information,education,communication(IEC),training,qualityassurance,monitoringandsupervision,andlogistics,inadditiontoprocurement.Withoutthis,muchofthefundsexpendedonRDTsmaybewasted,andalossofconfidenceinRDT-baseddiagnosismay
hindertheprocessofstrengtheningappropriatemalariacasemanagement.Afocalperson,orpersons,willbeneededtocoordinatetheoverallimplementationplanandtoensurethatthevariousagenciesthatmaybeinvolvedunderstandtheprocessandtheirparticularroles.
Examplesofwide-scalesuccessfulintroductionofmalariaRDTsarenowinexistenceinvariousnationalprogrammesandcomprehensivetechnicalguidanceonachievinguniversalaccesstomalariadiagnostictestinghasbeenpublished(30,31).FiguresA6.1andA6.2giveexamplesofthestepsandtimelinesforRDTimplementationandbudgetcomponentsforamalariadiagnosisprogramme,respectively.Thiswillneedtobemodifiedconsiderablyforeachprogramme.
annex 6: introducing rdt-based malaria diagnosis into national programmes
Key challenges
Changing past thinking that “fever equals malaria unless proven otherwise”.
IntroducingRDTswilldemonstratethatthisisnotthecase.Tohaveanimpactonanti-malarialdiagnosisandtreatment,RDTsmustbeseentoprovideanaccuratediagnosisbybothhealthworkersandpatientsalike,thatis,theymustbeasgoodorbetterthanthosereliedonpreviously.Ahealthworkerwillalsoneedagoodalternativetoanti-malarialmedicinesforthemanagementofparasite-negativefebrilepatients.ToachieveandmaintainconfidenceinRDT-baseddiagnosis,agoodqualityassurancesystemmustbeinplace.Theremustbesatisfactoryeducationofhealthworkers,andwidespreadcommunitysensitization.Knowledgeofothercausesoffeverwillbenecessarytodevelopappropriatemanagementalgorithmsforparasite-negativecases.
Changing and enforcing regulatory requirements
Atthenationallevel,regulatoryrequirementsmayneedtobedevelopedtocontroltheimportationanduseofmalariaRDTs,andnewproceduresforstorage,distributionandinventorymanagement,suchasthoseusedformedicines,mayneedtobedeveloped.
ann
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 123
Figu
re A
6.1.
Exa
mpl
e of
mal
aria
RDT
impl
emen
tatio
n st
eps
and
timel
inea
RDT
IMPL
EMEN
TATI
ON
TIM
ELIN
E
Coor
dina
ting
grou
pAp
poin
t m
alar
ia d
iagn
osis
coor
dina
tor(
s)
Polic
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com
men
datio
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ritte
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oH e
ndor
esm
ent
Prog
ram
Pla
nnin
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idel
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bW
ritte
nM
oH e
ndor
sem
ent
Case
man
agem
ent
of f
ever
of
unkn
own
orig
in
Case
man
agem
ent
of m
alar
ia
RDT
(and
mic
rosc
opy)
qua
lity
assu
ranc
e
RDT
tran
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Deci
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istric
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itial
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ased
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ent
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DT r
egist
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ate
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peci
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ent
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Dist
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ield
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ite S
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ec
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)124
Trai
ning
Cond
uct
case
man
agem
ent
trai
ning
for
fev
erM
ay b
e co
nduc
ted
earli
er, o
r al
read
y in
pla
ce
Mod
ify R
DT in
stru
ctio
ns a
nd t
rain
ing
man
ual
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d-te
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odfie
d tr
aini
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ctio
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Trai
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and
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sors
Hea
lth W
orke
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aini
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Advo
cacy
, Com
mun
icat
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Soc
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obili
satio
nEn
gagi
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ivil
soci
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orga
nisa
tions
Com
mun
ity s
ensit
isatio
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ging
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nion
lead
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ealth
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alua
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lop/
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etho
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or c
aptu
ring
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eren
t in
dica
tors
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rgra
te R
DTs
in t
he r
outin
e H
MIS
Plan
for
a p
ost-
intr
oduc
tion
prog
ram
rev
iew
a Ad
apte
d w
ith p
erm
issi
on fr
om F
IND
and
Uga
nda
Nat
iona
l Mal
aria
Con
trol
Pro
gram
me
b M
ay a
lread
y be
in p
lace
c Se
ntin
el s
ite m
ciro
scop
y, po
ssib
ly p
ositi
ve c
ontr
ol w
ells
in fu
ture
Figu
re A
6.1
(con
tinue
d)
ann
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) 125
Figure A6.2. Components of the budget for a malaria diagnosis programmea
Component Activities specific to microscopy
Activities specific to RDTs
Activities for management of (malaria and non-malaria) fevers
Preparation of technical guidelines, standard operating procedures and checklists
Guidelines Laboratory supervisionb RDT transport and storage Fever management algorithm
Standard operating procedures for diagnostic testing Microscopy performance RDT performance Other tests used at primary
care level
Other standard operating procedures Proficiency testing, validation of routine slide results RDT storage
Training material Training manual for microscopy Training manual for RDTs
Training manuals for integrated management of fevers
Checklists for supervision Laboratory visitsb Health facility visits
Procurement and supply of commodities
Diagnostic tests Microscopes and related supplies RDT kits
Urine dipsticks, haemoglobin meter, hematocrit meter, glucometer
Medicines ACTs Antibiotics, zinc, inhaled salbutamol, rehydration salts
Other commodities Gloves, lancets, alcohol, cotton wool, timers, sharps boxes
Distribution of commodities to the field All items listed above
Quality management system
Pre-shipment testing Lot-testing
Training of focal people Quality management system focal people
Monitoring the quality management system
Quality monitoring supervision visits and compilation of health information management data
Training of health workers
Training of tutors Expert microscopists Tutors for RDT performance outside laboratories and clinical management of fever cases
Training of health workers Microscopists Health workers Clinicians
Training of supervisors Laboratory supervisorsb Clinical supervisors
Supervision
Supervisory visits Laboratory visitsb Health facility visits
Advocacy, communication and social mobilization
Design of strategies and material Communication on the need for malaria testing Communication on other causes of fever
Dissemination of key messages Through each delivery channel
Monitoring and evaluation
Updating the health information management system
Add row for RDTs in laboratory report and column for malaria test results in clinicians’ book
Column for other test results in clinicians’ book
Train health workers in the new health information management system
Training of person in charge or focal person for reporting on health information management in health facilities
a Adapted with permission (30)b To simplify, activities specific to laboratories have been mentioned under ‘Microscopy’, although both microscopy and RDT are generally performed in laboratories.
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)126
Notes
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Mala
ria R
apid
Diag
nost
ic Te
st Pe
rform
ance
Re
sults
of W
HO p
rodu
ct te
sting
of m
alaria
RDT
s: Ro
und
4 (2
012)
TDR/World Health Organization20,AvenueAppia1211Geneva27Switzerland
Fax:(+41)[email protected]/tdr
FINDAvenuedeBudé161202GenevaSwitzerland
Fax:(+41)[email protected]
DOI:10.2471/TDR.09.978-924-1504720
ISBN9789241504720
![LWL]TL = ?P^ ;P]QZ]XLYNP - World Health Organization · IV Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 2 (2009) 10. laboratorY](https://img.pdfslide.us/doc/110x75/602e14c8b9b27762a62be3df/lwltl-p-pqzxlynp-world-health-organization-iv-malaria-rapid-diagnostic.jpg)
