Embed Size (px)
Citation preview
RDTMalaria_Round6_CoverBlack2.indd 1 10/12/2015 12:03
Malaria Rapid Diagnostic Test Performance
Summary results of WHO product testing of malaria RDTs: rounds 1-6 (2008–2015)
Malaria Rapid Diagnostic Test Performance
Summary results of WHO product testing of malaria RDTs: rounds 1-6 (2008–2015)
I I II I
WHO Library Cataloguing-in-Publication Data:
Malaria rapid diagnostic test performance: summary results of WHO product testing of malaria RDTs: rounds 1-6 (2008-2015)
I.World Health Organization.
ISBN 978 92 4 151004 2 Subject headings are available from WHO institutional repository
© World Health Organization 2015
All rights reserved. Publications of the World Health Organization are available on the WHO website (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]).
Requests for permission to reproduce or translate WHO publications –whether for sale or for non-commercial distribution– should be addressed to WHO Press through the WHO website (www.who.int/about/licensing/copyright_form/en/index.html).
The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement.
The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use.
Printed in Italy
Layout: Bruno Duret - Editor: Elisabeth Heseltine
Reference to any company or product in this report, particularly those listed in any of the figures and tables, does not constitute an endorsement, certification, or warranty of fitness by WHO of such company or product for any purpose, and does not imply any preference over companies or products of a similar nature that are not mentioned.
WHO does not furthermore warrant that: (1) the lists and figures are complete and/or error free; and/or that (2) any products included in the figures and tables 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 of any products in this report, particularly in any of the figures and tables listed on pages V-VII, does not furthermore imply any approval by WHO of these products (which is the sole prerogative of national authorities).
The WHO Programme of Prequalification of Diagnostics and Medical Devices uses the results of the WHO Malaria RDT Product Testing Programme as the laboratory evaluation component of the prequalification process for malaria RDTs. Although not currently a requirement for WHO procurement, manufacturers are encouraged to apply for WHO prequalification. A regularly updated list of WHO-prequalified diagnostics, including malaria RDTs, is available at http://www.who.int/diagnostics_laboratory/evaluations/PQ_list/en/.
WHO recommendations for procurement of malaria RDTs are currently based on the attainment of a set of minimum performance criteria in the WHO Malaria RDT Product Testing Programme. These recommendations were established by the WHO Malaria Policy Advisory Committee in 2012 , are outlined in this report and presented in full in a WHO information note (available at http://www.who.int/malaria/publications/atoz/rdt_selection_criteria_en.pdf?ua=1).Products that do not meet the full set of minimum performance criteria are not eligible for procurement by WHO.
The lists of RDTs included in this report are not exhaustive lists of malaria RDTs. These lists reflect those products which have been submitted for evaluation in Rounds 3-6 of the WHO Malaria RDT Product Testing Programme, and indicate to what extent these products, as manufactured by the listed companies, were -at the time of their evaluation- found to meet the above mentioned set of minimum performance criteria. The evaluation results indicated in the figures and tables apply only to the specific product as listed with its unique product code / catalogue number and as manufactured by the listed company.
The improper storage, transport and handling of malaria RDTs may affect their level of performance.
The fact that certain products are not included in the lists and figures in this report indicates that they have not or not yet been submitted for evaluation in the WHO Malaria RDT Product Testing Programme, or that their evaluation has not yet been completed and published in [a new edition of this report]. It does not however indicate anything in respect of such products’ performance. The lists and figures are updated regularly, and malaria RDTs are added to the lists and figures as and when (following the voluntary participation in the WHO Malaria RDT Product Testing Programme) their evaluation against the above mentioned set of minimum performance criteria has been completed.
Although the malaria RDTs listed in the tables and figures are regularly re-evaluated, and updated evaluation results are published by WHO, WHO cannot represent that products included in the lists and figures will continue to meet the performance criteria in the same manner as indicated. WHO recommends therefore that before procurement of a malaria RDT, each lot of that product undergoes lot testing at one of the two following lot-testing laboratories: Institut Pasteur du Cambodge (IPC), Cambodia or Research Institute for Tropical Medicine (RITM), The Philippines.
WHO disclaims any and all liability and 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 included in this report and the figures and tables listed on pages V-VII.
This report may not be used by manufacturers and suppliers for commercial or promotional purposes.
I I II I Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Contents Acknowledgements V
AbbreViAtions Vi
1. summAry of performAnce of rApid diAgnostic tests for mAlAriA: wHo product testing rounds 1–6 11.1. introduction 11.2. the wHo product testing programme 11.3. panel detection score and other results of the evaluation 21.4. summary of outcomes 41.5. delisting of products in summary report 41.6. How can product testing results inform rdt procurement and use? 41.7. product testing and wHo programme for prequalification of
diagnostics and medical devices 5
2. references 21
Annexes 23Annex s1: characteristics of evaluation panels used in rounds 1–6 of wHo malaria rdt product testing, 2008–2015 24Annex s2: malaria rdt field assessment and anomalies 27Annex s3: selection of an appropriate rdt 30
VIV Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
figures
Figure S1. Malaria RDT performance in phase 2 of rounds 3–6 against wild-type (clinical) samples containing P. falciparum at low (200) and high (2000 or 5000) parasite density (parasites/µL) and clean-negative samples
Figure S2. Malaria RDT performance in phase 2 of rounds 3–6 against wild-type (clinical) samples containing P. vivax at low (200) and high (2000 or 5000) parasite density (parasites/µL) and clean-negative samples
Figure S3. Panel detection score of malaria combination RDTs meeting WHO procurement criteria for false-positive and invalid rates, in phase 2 of rounds 3–6 against wild-type (clinical) samples containing P. falciparum and P. vivax at low parasite density (200 parasites/µL)
Figure AS1.1. Box-and-whisker plot of distribution of P. falciparum HRP2 concentration (ng/mL) in product testing phase 2 (wild-type) panels
Figure AS1.2. Box-and-whisker plot of distribution of P. falciparum pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels
Figure AS1.3. Box-and-whisker plot of distribution of P. vivax pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels
Figure AS1.4. Box-and-whisker plot of distribution of P. falciparum aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels
Figure AS1.5. Box-and-whisker plot of distribution of P. vivax aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels
Figure AS2.1. Malaria RDT anomalies encountered in production lots
Figure AS3.1. Selecting an appropriate RDT
tAbles
Table S1. Product resubmissions: WHO malaria RDT product testing rounds 1–6
Table S2. Malaria RDT phase-2 performance in rounds 3–6 against wild-type (clinical) samples containing P. falciparum and P. vivax at low (200) and high (2000 or 5000) parasite density (parasites/µL) and clean-negative samples
Table S3. Malaria RDT rounds 3–6 heat stability results on a cultured P. falciparum sample at low (200) and high (2000) parasite density (parasites/µL). Positivity rate at baseline (room temperature) and after 60 days incubation at room temperature, 35 °C and 45 °C
Table S4. Products evaluated during rounds 1-6 that have been removed from summary results listings
Table AS1.1. Statistics for P. falciparum HRP2 concentration (ng/mL) in product testing phase 2 (wild-type) panels
Table AS1.2. Statistics for P. falciparum pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels
Table AS1.3. Statistics for P. vivax pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels.
Table AS1.4. Statistics for P. falciparum aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels
Table AS1.5. Statistics for P. vivax aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels
Table AS2.1. Field assessment of RDT packaging, safety and ease-of-use to guide product selection
VIV Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Acknowledgements
The evaluation reported here was a joint project of the WHO Global Malaria Programme, the Foundation for Innovative New Diagnostics (FIND) and the United States Centers for Disease Control and Prevention (CDC) within the WHO-FIND Malaria RDT Evaluation Programme. The project was financed by FIND through a grant from UNITAID. The project would not have been possible without the cooperation and support of the specimen collection sites and specimen characterization laboratories mentioned, and the authors acknowledge the technical advice from many malaria diagnostic manufacturers and developers. This summary report of round 1-6 of WHO malaria RDT product testing was compiled by Jane Cunningham (WHO, Global Malaria Programme, Switzerland), Michelle Gatton (Queensland University of Technology, University of Queensland, Australia) and Sophie Jones (WHO, consultant).
The malaria RDT evaluation programme of WHO and FIND are grateful to all those who contributed to the evaluation and to the preparation of this report:
Salim Abdullah Ifakara Health Research and Development Centre, United Republic of Tanzania
Yong Ah United States Centers for Disease Control and Prevention, National Center for Global Health, Division of Malaria and Parasitic Diseases, United States
Frederic Ariey Institut Pasteur, Cambodia
John Barnwell United States Centers for Disease Control and Prevention, National Center for Global Health, Division of Malaria and Parasitic Diseases, United States
David Bell Foundation for Innovative New Diagnostics, Switzerland1
Andrea Bosman WHO, Global Malaria Programme, Switzerland
Qin Cheng Army Malaria Institute, Australia
Peter Chiodini Hospital for Tropical Diseases, United Kingdom
Jane Cunningham WHO, Global Malaria Programme, Switzerland
Djibrine Djalle Institut Pasteur of Bangui, Central African Republic
Dany Doung Institut Pasteur, Cambodia
Babacar Faye Université Cheikh Anta Diop, Senegal
Dionicia Gamboa Universidad Peruana Cayetano Heredia Instituto de Medicina Tropical, Peru
Michelle Gatton Queensland University of Technology, Australia
Jeffrey Glenn United States Centers for Disease Control and Prevention, National Center for Global Health, Division of Malaria and Parasitic Diseases, United States
Iveth Gonzalez Foundation for Innovative New Diagnostics, Switzerland
Sandra Incardona Foundation for Innovative New Diagnostics, Switzerland
Cara Kosack Médecins sans Frontières, Netherlands
Myat Phone Kyaw Department of Medical Research, Myanmar
Jennifer Luchavez Research Institute of Tropical Medicine, Philippines
Christian Luna Research Institute of Tropical Medicine, Philippines
James McCarthy Queensland Institute of Medical Research, University of Queensland, Australia
Didier Menard Institut Pasteur, Madagascar; Institut Pasteur, Cambodia
Rathana Meth Institut Pasteur, Cambodia
Claribel Murillo Centro Internacional de Entrenamiento e Investigaciones Médicas, Colombia
Sina Nhem Institut Pasteur, National Malaria Centre, Cambodia
Bernhards Ogutu Kenya Medical Research Institute, Kenya
Pamela Onyor Kenya Medical Research Institute, Kenya
1 Currently affiliated with Global Health Technologies Global Good Fund (Intellectual Ventures Lab), United States
1VI Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Wellington Oyibo University of Lagos, Nigeria
Mark Perkins Foundation for Innovative New Diagnostics, Switzerland
Roxanne Rees-Channer Consultant, Foundation for Innovative New Diagnostics, Hospital for Tropical Diseases, United Kingdom
Muth Sinuon National Malaria Centre, Cambodia
Johanna Beulah Sornillo Research Institute of Tropical Medicine, Philippines
Scott Wilson United States Centers for Disease Control and Prevention, National Center for Global Health, Division of Malaria and Parasitic Diseases, United States
AbbreViAtions
CDC United States Centers for Disease Control and Prevention
ELISA enzyme-linked immunosorbent assay
FIND Foundation for Innovative New Diagnostics
HRP2 histidine-rich protein 2
ISO International Organization for Standardization
PCR polymerase chain reaction
PDS panel detection score
pLDH Plasmodium lactate dehydrogenase
RDT rapid diagnostic test (for the purposes of this report, immunochromatographic lateral flow devices for the detection of malaria parasite antigens)
TDR Special Programme for Research and Training in Tropical Diseases sponsored by UNICEF, UNDP, the World Bank and WHO
Sum
ma
ry
ro
un
dS
1-6
1VI Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
1. summAry of performAnce of rApid diAgnostic tests for mAlAriA: wHo product testing rounds 1–6
1.1. introductionWHO estimates that 3.2 billion people are at risk for malaria. In 2014, there were an estimated 214 million cases (with an uncertainty range of 149 million to 303 million) and an estimated 438 000 deaths (with an uncertainty range of 236 000 to 635 000). Approximately 90% of all malaria deaths occur in sub-Saharan Africa, and nearly 70% occur in children under 5 years. Malaria remains endemic in 97 countries, and, while parasite-based diagnosis is increasing, approximately 35% of suspected malaria cases in Africa were not confirmed with a diagnostic test during 2014, resulting in over-use of antimalarial drugs and poor disease monitoring (1).
WHO recommends that malaria case management be based on parasite diagnosis in all cases (2). The use of antigen-detecting rapid diagnostic tests (RDTs) is a vital part of this strategy, forming the basis for extending access to malaria diagnosis by providing parasite-based diagnosis in areas where good-quality microscopy cannot be maintained. The number of RDTs available and the scale of their use have increased rapidly over the past few years; however, limita-tions of field trials and the heterogeneous nature of malaria transmission have limited the availability of the good-quality data on performance that national malaria programmes require to make informed decisions on procurement and implementation, and it is difficult to extrapolate the results of field trials to different populations and times. Therefore, in 2006, the WHO Special Programme for Research and Training in Tropical Diseases (TDR) and the Foundation for Innovative New Diagnostics (FIND) launched a programme to systematically evaluate and compare the performance of commercially available malaria RDTs.
The results of WHO’s malaria RDT product testing have been published annually since 2009 and form the basis of the procurement criteria of WHO, other United Nations agencies, the Global Fund to Fight AIDS, Tuberculosis and Malaria, national governments and nongovernmental organi-zations. The data have guided procurement decisions, which, in turn, have shifted markets towards better-performing tests (1) and are driving overall improvements in the quality of manufacturing.
RDT sales increased from 46 million sold in 2008 (before implementation of the product testing programme) to 314 million in 2014 (according to manufacturer sales data), when for the second time the number of diagnostic tests provided (RDTs and microscopy combined) exceeded the total number of courses of artemisinin-based combination therapy
(ACT) administered in Africa. In 2014, it was confirmed that all the 97 countries with ongoing malaria transmission had adopted the WHO policy to test before administering treat-ment. Despite these achievements, a large number of cases remain undiagnosed, particularly within the private sector, indicating that there are still some gains to be made (1).
This summary presents an overview of the results of rounds 3–6 of malaria RDT product testing and key concepts for understanding and using the results. It is published in conjunction with the release of the full report on round 6. With the exception of products that are no longer manu-factured and/or are delisted because of failure to comply with compulsory resubmission requirements, the results of all rounds of testing should be considered as a single data set. The separate, full reports of each round (3–7) should be consulted for further details of methods, product performance and interpretation of the results.
1.2. the wHo product testing programmeThe RDT evaluations summarized here were performed in collaboration by WHO, TDR, FIND, the United States Centers for Disease Control and Prevention (CDC) and other partners1. All companies that manufacture RDTs according to the ISO 13485:2003 quality system standard were invited to submit one to three products for evaluation. In each round of testing, products were evaluated against geographically diverse, cryopreserved Plasmodium falciparum and P. vivax clinical samples diluted to 200 and 2000 parasites/µL with consist-ently comparable concentration ranges of histidine-rich protein II (HRP2), Plasmodium lactate dehydrogenase (pLDH) and aldolase determined by quantitative enzyme-linked immunosorbent assay (ELISA) (Annex S1). In the first round of testing, 41 products from 21 manufacturers were evalu-ated against prepared blood panels of cultured P. falciparum parasites, while 29, 50, 48, 42 and 41 products from 13, 23, 27, 34 and 22 manufacturers were evaluated in rounds 2, 3, 4, 5 and 6, respectively. Of these 251 products, 247 progressed to testing against panels of patient-derived P. falciparum and P. vivax parasites and a parasite-negative panel. Thermal stability was assessed after 2 months of storage at elevated temperature and humidity, and a rudimentary assessment of ease of use was made. In round 6, specific observations of RDT anomalies were also systematically recorded. Many manufacturers have decided voluntarily to submit products to
1 See full reports of rounds 1–6 for lists of collaborating partners.
32 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
one or more rounds of testing, and, in round 5, a requirement was instituted to resubmit products for re-evaluation within 5 years of original testing (Table S1). Of the 247 fully evaluated products in rounds 1–6, 36 have been evaluated twice, 12 have been evaluated three times, two evaluated four times and two evaluated five times. Of the 171 unique products tested in the programme, 45 detect P. falciparum alone, 115 detect and differentiate P. falciparum from non-P. falciparum malaria (either pan-specific or species-specific for P. vivax or P. vivax, ovale and malariae), 10 detect P. falciparum and non-P. falciparum malaria without distinguishing between them, and one product was designed to detect P. vivax only. Manufacturers submitted two lots of each product for evaluation. When the same products (8) were resubmitted in subsequent rounds of testing, the second set of results replaced those from the earlier round. Thus, the performance of some tests in the results below differs from that reported in rounds 1–5.
Of the 19 products due for compulsory retesting in round 6, two were submitted (Table S1). Round 2 products that were not resubmitted have been removed from the figures and tables in this summary performance document.
The aim of the evaluation is to provide comparative data on the performance of the submitted production lots of each product. These data will be used to guide procure-ment decisions by WHO, other United Nations agencies and national governments and constitute the laboratory evaluation component of the WHO prequalification process for malaria RDTs (9). Product testing is part of a continuing programme of work to improve the quality of RDTs in use and to ensure reliable malaria diagnosis in areas where malaria is prevalent. A seventh round of product testing will begin in December 2015. The WHO Global Malaria Programme is currently assessing the impact of making WHO prequali-fication a requirement for procurement, including dossier and manufacture site assessment in addition to laboratory evaluation.
1.3. panel detection score and other results of the evaluationThe results (summarized in Figs S1–S3 and Tables S2 and S3) provide comparative data on two lots of products against a panel of parasite samples diluted in blood to a low density (200 parasites/µL) and a higher density (2000 or 5000 parasites/µL). The former is well below the mean parasite density found in many populations with endemic malaria and is considered close to the threshold that must be detected in order to reliably identify clinical malaria in many settings (10). For the purposes of this report, the main measure of performance is the panel detection score (PDS); for each RDT evaluated, the PDS is measured separately at the lower and the higher parasite densities. The summary figures also show the false-positive rates against blood samples containing no malaria parasites or known markers of other diseases and the rate of invalid results.
The PDS is the percentage of malaria samples in the panel that give a positive result in two RDTs per lot at the lower parasite density or by a single RDT per lot at the higher parasite density. As each sample is tested with RDTs from two lots, for a sample to be positive at the lower parasite density, it must show a positive result in four tests (two RDTs per lot for two lots); at the higher parasite density, it must show a positive result in two tests (one RDT per lot for two lots). Thus, the PDS is a combined measure of positivity rate incorporating inter-test and inter-lot consistency. As all tests performed on each sample must show a positive result for the sample to be considered positive, the PDS for a given RDT will usually be lower than a simple positivity rate per panel, measured by comparing the number of positive tests among all tests performed per panel. The PDS is also different from clinical sensitivity, which is the ability of the test to detect malaria infection in a given population of infected patients. Boxes 1 and 2 illustrate how the PDS is calculated and how it differs from a simple positivity rate for all samples tested and from clinical sensitivity in a population.
The PDS for a given RDT is different from the clinical sensi-tivity of that RDT (also called the true positive rate), which is a measure of the proportion of people known to have the disease who test positive for it. The sensitivity of malaria RDTs is highly dependent on local conditions, including the parasite density in the population; it therefore varies among populations with different levels of transmission, as their level of immunity affects the parasite density at which they exhibit symptoms that warrant a diagnostic test. Where transmission rates are low, the parasite densities in people with symptoms of malaria are likely to be low, and tests will be less sensitive. Test performance at 200 parasites/µL is therefore particularly important. The results in this report show the comparative performance of RDTs and indicate which products are likely to be more sensitive in the field, particularly in populations with low-density infections.
In general, as countries reduce the prevalence of malaria and even move towards malaria elimination, detection of low parasite densities becomes increasingly important in case management. As the high PDS at 2000 parasites/µL indicates, the sensitivity of many of these products is similar in populations with higher parasite densities; therefore, it is not possible to discriminate RDTs with superior performance.
An important caveat to estimating field sensitivity from the PDS provided in this report is that the panels used include only parasites known to express the target antigens. While non-expression of the target antigens has not been recorded for aldolase or pLDH, it is known that parasites that infect people in some areas of South America and India do not express HRP2 (11–12). In areas where HRP2-deleted parasites exist, tests for HRP2 will have greatly reduced sensitivity or be incapable of detecting P. falciparum. In such populations, only tests for pLDH or aldolase in P. falciparum parasites will be effective.
Heat stability (summarized in Table S3) is vital to main-taining the sensitivity of tests in the field. As a result, for
Sum
ma
ry
ro
un
dS
1-6
32 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Box 1: Example calculation of panel detection score and positivity rate for product A against a sample density of 200 parasites/µL
The first reading was at the minimum time specified by the manufacturer; the second reading was up to 30 min latera. A sample is considered detected only if all first test readings, from both lots, are positive, i.e. readings a, b, c and d must be positive.
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
a second reading results are for internal use only
P. falciparum sample a b c d
1 + - + + Sample NOT detected
2 + - - + Sample NOT detected
3 + + + + Sample detected
In this example, only one of three samples was positive all four times it was tested; the PDS is therefore 1/3 = 33%.
The positivity rate is calculated as the percentage of all tests of a particular product that returned a positive test result at the manufacturers’ recommended minimum reading time when tested against a P. falciparum or P. vivax sample.
In the above example, the positivity rate is: 9/12 = 75%.
The positivity rate is always greater than the PDS, except when the PDS and the positivity rate are both 100%.
Box 2: Performance measures in WHO product testing and in field settings: PDS versus clinical sensitivity
WHO Malaria RDT Product TestingPrimary performance measure: PDS indicates which products are likely to be more sensitive in the field, particularly in populations with low‐density infections.
200 parasites/μL
2000 parasites/μL
Reference panels: two fixed parasite densities allows discrimination in RDT performance.
Malaria endemic settingPerformance measure: sensitivity is the proportion of the popu-lation studied who have malaria for whom the test is positive.
- high, moderate, low transmission- immune, non-immune- vulnerable groups
Patients have varying parasite density. Most RDTs for P. falciparum and P. vivax perform well for a parasite density > 2000 parasites/μL, but clinically significant densities < 200 parasites/μL may be missed. The “overall” test performance will nevertheless be classified as very good in a field evaluation.
54 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
procurement, careful consideration must be given to ensure that the products to be used in areas with high temperatures of transport and storage have demonstrated stability in the product testing programme. Requirements vary among countries; for example, if tests are to be deployed in areas where temperatures rarely rise above 30 °C, less emphasis is needed on stability at high temperatures than on other aspects of quality.
Ease-of-use requirements depend on the extent of training and the work environment of the users. Particularly in primary health care settings, the simpler the test, the easier it will be to avoid errors in preparation and interpretation. Certain anomalies resulting from defects in production lots or RDT degradation may affect the running of the test or interpretation and may warrant a field safety notice and corrective action.
Detailed results can be found in the report of each evalua-tion (3–7) and at http://www.who.int/malaria/publications/diagnostic_testing/en/.
1.4. summary of outcomesThis laboratory-based evaluation provides a comparative, standardized measure of RDT performance for distinguishing between well and poorly performing tests to serve as a basis for procurement decisions by malaria control programmes and to guide United Nations procurement policy.
In round 6, the proportion of tests that achieved a PDS ≥ 75% at 200 parasites/µL is higher than all previous rounds for both P. falciparum (92.7%) and for P. vivax, (58.6%).
Several RDTs in the six rounds of testing consistently detected malaria at a low parasite density (200 parasites/µL), had low false-positive rates, are stable at tropical temperatures, are relatively easy to use and can detect P. falciparum or P. vivax infections or both.
Although the performance of the products varied widely at low parasite density (200 parasites/µL), all products had a high rate of detection of P. falciparum at 2000 or 5000 parasites/µL, as did the majority of products for P. vivax at 2000 parasites/µL.
All RDTs submitted to round 6 used the HRP2 antigen to detect P. falciparum, and all tests had a falciparum PDS that was < 100%. Three products were submitted that also detected Pf-pLDH. One product combined Pf-pLDH with HRP2 in the same test line, while the other two had dual test lines for detecting P. falciparum: one HPR2 test line and one Pf-pLDH test line. While both of the latter products performed well overall, the Pf-pLDH-detecting lines had considerably poorer performance than the HPR2-detecting test line, with a PDS of 36% and 52%, respectively. Thus, after six rounds of testing, the choice of well-performing pLDH-based P. falciparum tests remains limited, as it does for pan-only-specific tests.
The test performance of lots in round 6 did not vary much (Tables A3.1 and A4.1); in previous rounds, however, large variation has been found, confirming the advisability of
testing lots after purchase and before use in the field. Anomalies that can interfere with test interpretation were recorded regularly during round 6, each product had between one and six different types of anomaly (Annex S2, Table 8, Fig. 30). The frequency of anomalies was recorded for the first time in round 6. Incomplete clearing and red background were the most common anomalies, seen in 95% and 85% of products, respectively. Cases of failed migration, incomplete migration and patchy broken test lines were the anomalies seen next most regularly, in 34%, 32% and 37% of products, respectively. Most products (29/41) had anomalies in < 5% of the tests; nine products had anomalies in 5–10% of tests and three had anomalies in 16–98% of all tests (Table 8).
All the RDTs evaluated in round 6 were in cassette format.
Only two of the 19 RDTs due for compulsory resubmission were retested, and both met the WHO procurement criteria on initial and repeat testing; however, both products had diminished performance on re-testing, with a decrease in PDS of 7% and 4% against P. falciparum. The combination RDT product showed a comparable PDS against P. vivax to that obtained at initial testing. Both products showed decreases of 3.0% and 1.6% in false-positive rates on re-testing.
1.5. delisting of products in summary reportManufacturers who choose not to submit products due for compulsory resubmission (every 5 years) are removed from the summary results listing (Tables S2 and S3) and the online interactive database (13) and are featured only in the full round-specific product testing report. They are also not eligible for WHO procurement. Furthermore, a product is delisted if WHO is notified by the manufacturer that its production has been discontinued. To date, 51 products have been delisted (Table S4).
1.6. How can product testing results inform rdt procurement and use?Accurate diagnosis is vital to good malaria case manage-ment, whether based on microscopy or RDTs. The results of this report should be used to make a short list of RDTs for procurement for use in settings where good microscopy is not available or appropriate. Box 3 lists WHO’s minimum criteria for RDT selection, and Annex S3 provides a step-by-step approach to selecting an RDT, taking into consideration local malaria transmission and illness where the tests will be used (e.g. Plasmodium spp., target antigen, parasite densities, climate) and other important considerations, including ease of use in the field (Annex S2), training or retraining require-ments and lot testing1.
The results in Table S2 indicate WHO prequalification status and are colour-coded to reflect achievement of WHO
1 The WHO-FIND malaria RDT evaluation programme provides lot-testing capacity in two regional laboratories free of charge; it can be accessed at [email protected] and [email protected].
Sum
ma
ry
ro
un
dS
1-6
54 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
performance requirements for RDT procurement. A web-based tool that allows filtering of product testing results by various parameters to assist in selecting products with the performance characteristics most suitable for a country’s health programme is available and maintained by FIND (13). This online database has been updated to allow filtering of results by RDT procedural characteristics, such as blood volume requirements, number of buffer drops and time to a result. This will allow identification of products with similar procedures so that, when product replacement is required, another product can be selected with the same or a similar protocol. Use of similar products may reduce the need for user retraining and reduce user error.
Comprehensive guidance on several aspects of procurement can be found in Good practices for selecting and procuring rapid diagnostic tests for malaria (14) and guidance on implementation in Universal access to malaria diagnosis (15).
1.7. product testing and wHo programme for prequalification of diagnostics and medical devicesIn the WHO programme for prequalification of diagnostics and medical devices, the results of product testing are used as the laboratory evaluation component of the prequalification process for malaria RDTs. These data are used to set priorities for dossier review and inspection. Although prequalification is not currently a requirement for WHO procurement, manu-facturers are encouraged to apply for it, as it may become a requirement for WHO procurement in the future. Prequalified RDTs are listed in summary tables and at http://www.who.int/diagnostics_laboratory/evaluations/PQ_list/en/.
Box 3: WHO selection criteria for the procurement of RDTs
Products should be selected in line with the following set of criteria, based on the results of the assessment of the WHO Malaria RDT Product Testing Programme:
(A) For the detection of Plasmodium falciparum (Pf) in all transmission settings the panel detection score (PDS) against Pf samples should be at least 75% at 200 parasites/µL.
(B) For the detection of Plasmodium vivax (Pv) in all transmission settings the panel detection score (PDS) against Pv samples should be at least 75% at 200 parasites/µL.
(C) The false positive rate should be less than 10%.
(D) The invalid rate should be less than 5%.
Only products meeting performance criteria outlined in A,B,C and D are recommended for procurement
76 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Figure S1: Malaria RDT performance in phase 2 of rounds 3-6 against wild-type (clinical) samples containing P. falciparum at low (200) and high (2000 or 5000) parasite density (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
Cor
e™ M
alar
ia P
an P
f MAL
-190
024
diag
nost
icks
MAL
ARIA
(Pan
/Pf)
Cas
sette
MPN
FWBC
1007
.4C
ore™
Mal
aria
Pv/
Pf M
AL-1
9002
2C
ore™
Mal
aria
Pf
MAL
-190
020
Para
chec
k® P
f - R
apid
test
for P
. fal
cipa
rum
Mal
aria
Dev
ice
Ver.
3 3
0203
0025
Firs
t Res
pons
e® M
alar
ia A
g P.
falc
ipar
um (H
RP2
) Car
d Te
st I1
3FR
C25
SD B
IOLI
NE
Mal
aria
Ag
Pf 0
5FK5
0M
alar
ia p
f (H
RP
II) /
(PAN
-pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
MFV
-124
RFi
rstS
ign™
Mal
aria
Pf 2
100C
B-25
One
Ste
p M
alar
ia P
.F T
est (
cass
ette
) 5
2235
2SD
BIO
LIN
E M
alar
ia A
g P.
f/Pan
05
FK60
/05F
K63
diag
nost
icks
MAL
ARIA
(Pan
/Pv/
Pf) C
asse
tte M
PNVF
C10
07.5
Rap
id 1
-2-3
® H
ema®
Cas
sette
Mal
aria
PF
MAL
-PF-
CAS
/25
(100
)IC
T M
alar
ia D
ual T
est
ML0
3C
ore™
Mal
aria
Pan
/Pv/
Pf M
AL-1
9002
6BI
ON
OTE
MAL
ARIA
P.f.
& P.
v. A
g R
apid
Tes
t Kit
RG
19-1
2N
anoS
ign
Mal
aria
Pf/P
an A
g 3.
0 R
MAP
10H
umas
is M
alar
ia P
.f/P.
v An
tigen
Tes
t AM
FV-7
025
RAP
ID 1
-2-3
® H
EMA
CAS
SETT
E M
ALAR
IA P
F/PV
TES
T M
AL-P
FV-C
AS/2
5(10
0)R
apiG
EN B
IOC
RED
IT M
alar
ia A
g Pf
/Pv
(HR
PII/p
LDH
) C40
RH
A25
One
Ste
p M
alar
ia P
.F/P
.V T
est (
Cas
sette
) 523
352
SD B
iolin
e M
alar
ia A
g P.
f/P.v
05F
K80
Car
eSta
rt™ M
alar
ia H
RP2
(Pf)
G01
41/G
0141
-ET
Car
eSta
rt™ M
alar
ia H
RP2
/pLD
H P
f tes
t G01
81/G
0181
-ET
Firs
t Res
pons
e® M
alar
ia A
g P.
falc
ipar
um (H
RP2
) Car
d Te
st P
I13F
RC
Mal
aria
Ant
igen
Tes
t-Pf M
AG01
040
BioT
race
r™ M
alar
ia P
.f/P.
v R
apid
Car
d 17
412
KHB®
Mal
aria
Ag
P.f/P
.v R
apid
Tes
t KH
-R-0
7-50
Car
eSta
rt™ M
alar
ia H
RP2
/pLD
H (P
f/Pv)
CO
MBO
G01
61/G
0161
-ET
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
an 0
5FK6
6AT
OM
OR
APID
™ M
ALAR
IA (P
F/PA
N) M
MAL
01C
areS
tart™
Mal
aria
HR
P2/p
LDH
(Pf/P
AN) C
OM
BO G
0131
/G01
31-E
TD
IAQ
UIC
K M
alar
ia P
.f/Pa
n C
asse
tte Z
1120
0CE
Rap
iGEN
BIO
CR
EDIT
Mal
aria
Ag
Pf/P
an (H
RPI
I/pLD
H) C
30R
HA2
5H
umas
is M
alar
ia P
.f/Pa
n An
tigen
Tes
t AM
AL-7
025
NG
-Tes
t MAL
ARIA
Pf/P
an (p
LDH
) N
G-M
AL-W
23-0
01M
alar
ia P
V/PF
(pLD
H/H
RP2
) Ant
igen
Tes
t Inf
-72
Car
eSta
rt™ M
alar
ia H
RP2
/pLD
H (P
f/VO
M) C
OM
BO G
0171
/G01
71-E
TH
iSen
s M
alar
ia A
g P.
f/VO
M C
ombo
Car
d H
R33
23H
iSen
s M
alar
ia A
g P.
f/P.v
Com
bo C
ard
HR
3123
Adva
ntag
e P.
f. M
alar
ia C
ard
IR01
6025
Mal
aria
Pf/P
an O
ne S
tep
Rap
id T
est
RT
2022
2H
umas
is M
alar
ia P
.f/Pa
n An
tigen
Tes
t AN
MAL
-702
5C
areS
tart™
Mal
aria
pLD
H 3
Lin
e Te
st G
0121
Trus
ty™
Mal
aria
Ant
igen
P.f.
test
A03
-11-
322
Trus
ty™
Mal
aria
Ant
igen
P.f.
/p.v
. tes
t A03
-12-
322
SD B
IOLI
NE
Mal
aria
Ag
P.f.
(HR
P2/p
LDH
) - 0
5FK9
0BI
ON
OTE
MAL
ARIA
P.f.
Ag
Rap
id T
est K
it R
G19
-11
Hum
asis
Mal
aria
P.f/
P.v
Antig
en T
est A
NM
IV-7
025
Rap
iGEN
BIO
CR
EDIT
Mal
aria
Ag
Pf (H
RPI
I) C
10R
HA2
5Ad
vanc
ed™
Qua
lity
Rap
id M
alar
ia T
est (
Pf/P
an)
ITP1
1005
Is It
… M
alar
ia P
f/Pv
Dev
ice
AL03
0Fi
rstS
ign™
- Pa
raVi
ew (P
an+P
f) M
alar
ia T
est 2
101C
B-25
Hum
asis
Mal
aria
P.f
Antig
en T
est A
NM
PF-7
025
Car
eSta
rt™ M
alar
ia S
cree
n G
0231
ICT
Dia
gnos
tics
Mal
aria
P.f.
M
L01
Viki
a® M
alar
ia A
g Pf
/Pan
412
499
ABO
N™
Plu
s M
alar
ia P
.f/Pa
n R
apid
Tes
t Dev
ice
(Who
le B
lood
) IM
A-T4
02Fi
rst R
espo
nse®
Mal
aria
pLD
H/H
RP2
Com
bo T
est I
16FR
CSD
Bio
line
Mal
aria
Ag
P.f/P
.f/P.
v 05
FK12
0Fi
rst R
espo
nse®
Mal
aria
Ag
Pf/P
v C
ard
Test
PI1
9FR
CO
ne S
tep
Mal
aria
P.f
Who
le b
lood
Tes
t W37
-CM
alar
ia P
f (H
RPI
I) PV
(PLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
GM
006
Para
HIT
® -
f Ve
r. 1
(Dev
ice)
55I
C10
4-50
Nan
oSig
n M
alar
ia P
f Ag
RM
AF10
Para
HIT
- To
tal V
er. 1
.0 (D
evic
e) 5
5IC
204-
10Ad
vant
age
Mal
aria
Pan
+ P
f Car
d IR
2310
25C
areS
tart™
Mal
aria
pLD
H (P
AN) G
0111
Mal
eris
can®
Mal
aria
P.f/
PAN
(Pv,
Pm
, Po)
3 L
ine
Antig
en T
est M
AT-P
F/PA
N-5
0G
enBo
dy™
Mal
aria
Pf/P
an A
g M
ALAG
100
Car
eSta
rt™ M
alar
ia/P
regn
ancy
Com
bo (p
LDH
/HR
P2/H
CG
) G
0221
Mal
eris
can
® M
alar
ia P
.f An
tigen
Tes
t MAT
-PF-
50Bi
oTra
cer™
Mal
aria
P.f/
PAN
Rap
id C
ard
1701
2BI
ON
OTE
MAL
ARIA
P.f
& Pa
n Ag
Rap
id T
est K
it R
G19
-08
Mal
asca
n™ D
evic
e - R
apid
test
for M
alar
ia P
f/Pan
50
4020
25Fi
rst R
espo
nse®
Mal
aria
Ag.
pLD
H/H
RP2
Com
bo C
ard
Test
PI1
6FR
CIM
MU
NO
QU
ICK
CO
NTA
CT
falc
ipar
um 0
519K
25AS
AN E
asy
Test
® M
alar
ia P
f/Pan
Ag
AM
4650
-KPa
raH
IT® -f
Ver
. 1 (D
ipst
ick)
55I
C10
3-50
Falc
ivax
™ R
apid
Tes
t for
Mal
aria
Pv/
Pf 5
0301
0025
Mal
aria
pf (
HR
P II)
/ pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
MFV
-124
VKH
B® M
alar
ia A
g P.
f Rap
id T
est
KH-R
-06-
20R
ight
Sign
® M
alar
ia P
.f. R
apid
Tes
t Cas
sette
(Who
le B
lood
) IM
PF-C
51Pa
rasc
reen
® -
Rap
id T
est f
or M
alar
ia P
an/P
f 503
0300
25Q
uick
Prof
ile™
Mal
aria
Pf/P
an T
est 7
1063
EzD
x™ M
alar
ia P
an/P
f Rap
id te
st d
etec
tion
Kit R
F M
AL 0
01C
oret
ests
® O
ne S
tep
Mal
aria
Pf/P
v Ag
Tes
t Dev
ice
B42-
21/B
42-2
2Q
uick
Prof
ile™
Mal
aria
Pf/P
v Te
st 7
1050
One
Ste
p M
alar
ia P
.f/P.
v W
hole
Blo
od T
est W
056-
CO
nSite
Mal
aria
Pf/P
an A
g R
apid
Tes
t R01
13C
Adva
ntag
e M
alar
ia C
ard
IR21
1025
Adva
ntag
e Pa
n M
alar
ia C
ard
IR01
3025
One
Ste
p M
alar
ia P
.f/Pa
n W
hole
Blo
od T
est W
62-C
Mer
iscr
een
Mal
aria
Pf/P
an A
g M
HLR
PD-0
1Pa
raH
IT -
Tota
l Ver
. 1.0
(Dip
stic
k) 5
5IC
203-
10M
eris
cree
n M
alar
ia P
f/Pv
Ag M
FLR
PD-0
1Ez
Dx™
Mal
aria
Pv/
Pf R
apid
Mal
aria
ant
igen
det
ectio
n te
st R
K M
AL 0
03IM
MU
NO
QU
ICK
CO
NTA
CT
MAL
ARIA
+4
052
5K25
OnS
ite M
alar
ia P
f Ag
Rap
id T
est R
0114
CAd
vanc
ed Q
ualit
y™ O
ne S
tep
Mal
aria
(Pf
/Pv)
Tri-
line
Test
(who
le b
lood
) ITP
1100
3 TC
40R
ight
Sign
™ M
alar
ia P
.f/Pa
n R
apid
Tes
t Cas
sette
IM
PN-C
52O
nSite
Mal
aria
Pf/P
v Ag
Rap
id T
est R
0112
CIm
mun
oqui
ck M
alar
ia F
alci
paru
m 0
502_
K25
EzD
x™ M
alar
ia P
f Rap
id M
alar
ia a
ntig
en d
etec
tion
test
RK
MAL
008
Para
chec
k® P
f - R
apid
test
for P
. fal
cipa
rum
Mal
aria
Dip
stic
k (V
er.3
) 302
0400
25M
eDiP
ro M
alar
ia A
g H
RP2
/pLD
H C
ombo
IR-0
051K
Gen
edia
® M
alar
ia P
.f/Pa
n Ag
Rap
id T
est
20-0
146-
01AC
CU
CAR
E O
NE
STEP
MAL
ARIA
Pf/P
an A
ntig
en T
est
MAG
C 2
5M
alar
ia p
f (H
RP
II)/P
AN (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e 1-
13-1
01-1
Para
HIT
®fV
Rap
id te
st fo
r P. f
alci
paru
m a
nd P
.viv
ax M
alar
ia -
Dev
ice
55IC
402-
50AZ
OG
Mal
aria
pf (
HR
PII)/
pf (L
DH
)/ (P
AN-L
DH
) Ant
igen
Det
ectio
n D
evic
e M
FV-1
24F
AZO
G h
CG
Mal
aria
Det
ectio
n Te
st D
evic
e M
PT-1
24M
alar
ia P
f./Pa
n An
tigen
(MAL
Pf/P
an) T
est K
it A
03-1
8-32
2M
alar
ia p
f (H
RP
II) /
pv (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e 1-
13-1
01-3
Mal
aria
Pan
Tes
t M
AL-W
23N
-001
Adva
nced
Qua
lity™
One
Ste
p M
alar
ia P
.f Te
st I
TP11
002T
C1/
TC40
Opt
iMAL
-IT 7
1002
4M
alar
ia p
f (pL
DH
) / P
AN-p
LDH
Tes
t Dev
ice
M
FV-1
24M
alar
ia P
f/Pv
GM
002
Mal
aria
Pf/
PAN
GM
004
One
Ste
p M
alar
ia P
.f/Pa
n Te
st
W56
-CAB
ON
™ M
alar
ia P
.f. R
apid
Tes
t Dev
ice
(Who
le B
lood
) IM
A-40
2Ad
vant
age
Mal
Car
d IR
2210
25Pa
raba
nk™
Dev
ice
- Rap
id te
st fo
r Mal
aria
Pan
50
3010
25SD
BIO
LIN
E M
alar
ia A
g 0
5FK4
0di
agno
stic
ks M
ALAR
IA (P
an) C
asse
tte M
PNW
BC10
07.3
Nan
oSig
n M
alar
ia P
f/Pv
Ag R
MAD
10
100
90
80
70
60
50
40
30
20
10
0
100
80
60
40
20
0
Fal
se-p
osi
tive Plasm
odium
sp
p.
rate
on
clea
n-ne
gat
ive
sam
ple
sb (%
)an
d in
valid
rat
e (%
)
Pan
el d
etec
tio
n s
core
a
200 parasites/µL (HRP2)200 parasites/µL (non-HRP2)2000 parasites/µL (HRP2)2000 parasites/µL (non-HRP2)False-positive Plasmodium spp. rate (%)Invalid rate (%)
Sum
ma
ry
ro
un
dS
1-6
76 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Figure S1: Malaria RDT performance in phase 2 of rounds 3-6 against wild-type (clinical) samples containing P. falciparum at low (200) and high (2000 or 5000) parasite density (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
Cor
e™ M
alar
ia P
an P
f MAL
-190
024
diag
nost
icks
MAL
ARIA
(Pan
/Pf)
Cas
sette
MPN
FWBC
1007
.4C
ore™
Mal
aria
Pv/
Pf M
AL-1
9002
2C
ore™
Mal
aria
Pf
MAL
-190
020
Para
chec
k® P
f - R
apid
test
for P
. fal
cipa
rum
Mal
aria
Dev
ice
Ver.
3 3
0203
0025
Firs
t Res
pons
e® M
alar
ia A
g P.
falc
ipar
um (H
RP2
) Car
d Te
st I1
3FR
C25
SD B
IOLI
NE
Mal
aria
Ag
Pf 0
5FK5
0M
alar
ia p
f (H
RP
II) /
(PAN
-pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
MFV
-124
RFi
rstS
ign™
Mal
aria
Pf 2
100C
B-25
One
Ste
p M
alar
ia P
.F T
est (
cass
ette
) 5
2235
2SD
BIO
LIN
E M
alar
ia A
g P.
f/Pan
05
FK60
/05F
K63
diag
nost
icks
MAL
ARIA
(Pan
/Pv/
Pf) C
asse
tte M
PNVF
C10
07.5
Rap
id 1
-2-3
® H
ema®
Cas
sette
Mal
aria
PF
MAL
-PF-
CAS
/25
(100
)IC
T M
alar
ia D
ual T
est
ML0
3C
ore™
Mal
aria
Pan
/Pv/
Pf M
AL-1
9002
6BI
ON
OTE
MAL
ARIA
P.f.
& P.
v. A
g R
apid
Tes
t Kit
RG
19-1
2N
anoS
ign
Mal
aria
Pf/P
an A
g 3.
0 R
MAP
10H
umas
is M
alar
ia P
.f/P.
v An
tigen
Tes
t AM
FV-7
025
RAP
ID 1
-2-3
® H
EMA
CAS
SETT
E M
ALAR
IA P
F/PV
TES
T M
AL-P
FV-C
AS/2
5(10
0)R
apiG
EN B
IOC
RED
IT M
alar
ia A
g Pf
/Pv
(HR
PII/p
LDH
) C40
RH
A25
One
Ste
p M
alar
ia P
.F/P
.V T
est (
Cas
sette
) 523
352
SD B
iolin
e M
alar
ia A
g P.
f/P.v
05F
K80
Car
eSta
rt™ M
alar
ia H
RP2
(Pf)
G01
41/G
0141
-ET
Car
eSta
rt™ M
alar
ia H
RP2
/pLD
H P
f tes
t G01
81/G
0181
-ET
Firs
t Res
pons
e® M
alar
ia A
g P.
falc
ipar
um (H
RP2
) Car
d Te
st P
I13F
RC
Mal
aria
Ant
igen
Tes
t-Pf M
AG01
040
BioT
race
r™ M
alar
ia P
.f/P.
v R
apid
Car
d 17
412
KHB®
Mal
aria
Ag
P.f/P
.v R
apid
Tes
t KH
-R-0
7-50
Car
eSta
rt™ M
alar
ia H
RP2
/pLD
H (P
f/Pv)
CO
MBO
G01
61/G
0161
-ET
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
an 0
5FK6
6AT
OM
OR
APID
™ M
ALAR
IA (P
F/PA
N) M
MAL
01C
areS
tart™
Mal
aria
HR
P2/p
LDH
(Pf/P
AN) C
OM
BO G
0131
/G01
31-E
TD
IAQ
UIC
K M
alar
ia P
.f/Pa
n C
asse
tte Z
1120
0CE
Rap
iGEN
BIO
CR
EDIT
Mal
aria
Ag
Pf/P
an (H
RPI
I/pLD
H) C
30R
HA2
5H
umas
is M
alar
ia P
.f/Pa
n An
tigen
Tes
t AM
AL-7
025
NG
-Tes
t MAL
ARIA
Pf/P
an (p
LDH
) N
G-M
AL-W
23-0
01M
alar
ia P
V/PF
(pLD
H/H
RP2
) Ant
igen
Tes
t Inf
-72
Car
eSta
rt™ M
alar
ia H
RP2
/pLD
H (P
f/VO
M) C
OM
BO G
0171
/G01
71-E
TH
iSen
s M
alar
ia A
g P.
f/VO
M C
ombo
Car
d H
R33
23H
iSen
s M
alar
ia A
g P.
f/P.v
Com
bo C
ard
HR
3123
Adva
ntag
e P.
f. M
alar
ia C
ard
IR01
6025
Mal
aria
Pf/P
an O
ne S
tep
Rap
id T
est
RT
2022
2H
umas
is M
alar
ia P
.f/Pa
n An
tigen
Tes
t AN
MAL
-702
5C
areS
tart™
Mal
aria
pLD
H 3
Lin
e Te
st G
0121
Trus
ty™
Mal
aria
Ant
igen
P.f.
test
A03
-11-
322
Trus
ty™
Mal
aria
Ant
igen
P.f.
/p.v
. tes
t A03
-12-
322
SD B
IOLI
NE
Mal
aria
Ag
P.f.
(HR
P2/p
LDH
) - 0
5FK9
0BI
ON
OTE
MAL
ARIA
P.f.
Ag
Rap
id T
est K
it R
G19
-11
Hum
asis
Mal
aria
P.f/
P.v
Antig
en T
est A
NM
IV-7
025
Rap
iGEN
BIO
CR
EDIT
Mal
aria
Ag
Pf (H
RPI
I) C
10R
HA2
5Ad
vanc
ed™
Qua
lity
Rap
id M
alar
ia T
est (
Pf/P
an)
ITP1
1005
Is It
… M
alar
ia P
f/Pv
Dev
ice
AL03
0Fi
rstS
ign™
- Pa
raVi
ew (P
an+P
f) M
alar
ia T
est 2
101C
B-25
Hum
asis
Mal
aria
P.f
Antig
en T
est A
NM
PF-7
025
Car
eSta
rt™ M
alar
ia S
cree
n G
0231
ICT
Dia
gnos
tics
Mal
aria
P.f.
M
L01
Viki
a® M
alar
ia A
g Pf
/Pan
412
499
ABO
N™
Plu
s M
alar
ia P
.f/Pa
n R
apid
Tes
t Dev
ice
(Who
le B
lood
) IM
A-T4
02Fi
rst R
espo
nse®
Mal
aria
pLD
H/H
RP2
Com
bo T
est I
16FR
CSD
Bio
line
Mal
aria
Ag
P.f/P
.f/P.
v 05
FK12
0Fi
rst R
espo
nse®
Mal
aria
Ag
Pf/P
v C
ard
Test
PI1
9FR
CO
ne S
tep
Mal
aria
P.f
Who
le b
lood
Tes
t W37
-CM
alar
ia P
f (H
RPI
I) PV
(PLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
GM
006
Para
HIT
® -
f Ve
r. 1
(Dev
ice)
55I
C10
4-50
Nan
oSig
n M
alar
ia P
f Ag
RM
AF10
Para
HIT
- To
tal V
er. 1
.0 (D
evic
e) 5
5IC
204-
10Ad
vant
age
Mal
aria
Pan
+ P
f Car
d IR
2310
25C
areS
tart™
Mal
aria
pLD
H (P
AN) G
0111
Mal
eris
can®
Mal
aria
P.f/
PAN
(Pv,
Pm
, Po)
3 L
ine
Antig
en T
est M
AT-P
F/PA
N-5
0G
enBo
dy™
Mal
aria
Pf/P
an A
g M
ALAG
100
Car
eSta
rt™ M
alar
ia/P
regn
ancy
Com
bo (p
LDH
/HR
P2/H
CG
) G
0221
Mal
eris
can
® M
alar
ia P
.f An
tigen
Tes
t MAT
-PF-
50Bi
oTra
cer™
Mal
aria
P.f/
PAN
Rap
id C
ard
1701
2BI
ON
OTE
MAL
ARIA
P.f
& Pa
n Ag
Rap
id T
est K
it R
G19
-08
Mal
asca
n™ D
evic
e - R
apid
test
for M
alar
ia P
f/Pan
50
4020
25Fi
rst R
espo
nse®
Mal
aria
Ag.
pLD
H/H
RP2
Com
bo C
ard
Test
PI1
6FR
CIM
MU
NO
QU
ICK
CO
NTA
CT
falc
ipar
um 0
519K
25AS
AN E
asy
Test
® M
alar
ia P
f/Pan
Ag
AM
4650
-KPa
raH
IT® -f
Ver
. 1 (D
ipst
ick)
55I
C10
3-50
Falc
ivax
™ R
apid
Tes
t for
Mal
aria
Pv/
Pf 5
0301
0025
Mal
aria
pf (
HR
P II)
/ pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
MFV
-124
VKH
B® M
alar
ia A
g P.
f Rap
id T
est
KH-R
-06-
20R
ight
Sign
® M
alar
ia P
.f. R
apid
Tes
t Cas
sette
(Who
le B
lood
) IM
PF-C
51Pa
rasc
reen
® -
Rap
id T
est f
or M
alar
ia P
an/P
f 503
0300
25Q
uick
Prof
ile™
Mal
aria
Pf/P
an T
est 7
1063
EzD
x™ M
alar
ia P
an/P
f Rap
id te
st d
etec
tion
Kit R
F M
AL 0
01C
oret
ests
® O
ne S
tep
Mal
aria
Pf/P
v Ag
Tes
t Dev
ice
B42-
21/B
42-2
2Q
uick
Prof
ile™
Mal
aria
Pf/P
v Te
st 7
1050
One
Ste
p M
alar
ia P
.f/P.
v W
hole
Blo
od T
est W
056-
CO
nSite
Mal
aria
Pf/P
an A
g R
apid
Tes
t R01
13C
Adva
ntag
e M
alar
ia C
ard
IR21
1025
Adva
ntag
e Pa
n M
alar
ia C
ard
IR01
3025
One
Ste
p M
alar
ia P
.f/Pa
n W
hole
Blo
od T
est W
62-C
Mer
iscr
een
Mal
aria
Pf/P
an A
g M
HLR
PD-0
1Pa
raH
IT -
Tota
l Ver
. 1.0
(Dip
stic
k) 5
5IC
203-
10M
eris
cree
n M
alar
ia P
f/Pv
Ag M
FLR
PD-0
1Ez
Dx™
Mal
aria
Pv/
Pf R
apid
Mal
aria
ant
igen
det
ectio
n te
st R
K M
AL 0
03IM
MU
NO
QU
ICK
CO
NTA
CT
MAL
ARIA
+4
052
5K25
OnS
ite M
alar
ia P
f Ag
Rap
id T
est R
0114
CAd
vanc
ed Q
ualit
y™ O
ne S
tep
Mal
aria
(Pf
/Pv)
Tri-
line
Test
(who
le b
lood
) ITP
1100
3 TC
40R
ight
Sign
™ M
alar
ia P
.f/Pa
n R
apid
Tes
t Cas
sette
IM
PN-C
52O
nSite
Mal
aria
Pf/P
v Ag
Rap
id T
est R
0112
CIm
mun
oqui
ck M
alar
ia F
alci
paru
m 0
502_
K25
EzD
x™ M
alar
ia P
f Rap
id M
alar
ia a
ntig
en d
etec
tion
test
RK
MAL
008
Para
chec
k® P
f - R
apid
test
for P
. fal
cipa
rum
Mal
aria
Dip
stic
k (V
er.3
) 302
0400
25M
eDiP
ro M
alar
ia A
g H
RP2
/pLD
H C
ombo
IR-0
051K
Gen
edia
® M
alar
ia P
.f/Pa
n Ag
Rap
id T
est
20-0
146-
01AC
CU
CAR
E O
NE
STEP
MAL
ARIA
Pf/P
an A
ntig
en T
est
MAG
C 2
5M
alar
ia p
f (H
RP
II)/P
AN (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e 1-
13-1
01-1
Para
HIT
®fV
Rap
id te
st fo
r P. f
alci
paru
m a
nd P
.viv
ax M
alar
ia -
Dev
ice
55IC
402-
50AZ
OG
Mal
aria
pf (
HR
PII)/
pf (L
DH
)/ (P
AN-L
DH
) Ant
igen
Det
ectio
n D
evic
e M
FV-1
24F
AZO
G h
CG
Mal
aria
Det
ectio
n Te
st D
evic
e M
PT-1
24M
alar
ia P
f./Pa
n An
tigen
(MAL
Pf/P
an) T
est K
it A
03-1
8-32
2M
alar
ia p
f (H
RP
II) /
pv (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e 1-
13-1
01-3
Mal
aria
Pan
Tes
t M
AL-W
23N
-001
Adva
nced
Qua
lity™
One
Ste
p M
alar
ia P
.f Te
st I
TP11
002T
C1/
TC40
Opt
iMAL
-IT 7
1002
4M
alar
ia p
f (pL
DH
) / P
AN-p
LDH
Tes
t Dev
ice
M
FV-1
24M
alar
ia P
f/Pv
GM
002
Mal
aria
Pf/
PAN
GM
004
One
Ste
p M
alar
ia P
.f/Pa
n Te
st
W56
-CAB
ON
™ M
alar
ia P
.f. R
apid
Tes
t Dev
ice
(Who
le B
lood
) IM
A-40
2Ad
vant
age
Mal
Car
d IR
2210
25Pa
raba
nk™
Dev
ice
- Rap
id te
st fo
r Mal
aria
Pan
50
3010
25SD
BIO
LIN
E M
alar
ia A
g 0
5FK4
0di
agno
stic
ks M
ALAR
IA (P
an) C
asse
tte M
PNW
BC10
07.3
Nan
oSig
n M
alar
ia P
f/Pv
Ag R
MAD
10
100
90
80
70
60
50
40
30
20
10
0
100
80
60
40
20
0
Fal
se-p
osi
tive Plasm
odium
sp
p.
rate
on
clea
n-ne
gat
ive
sam
ple
sb (%
)an
d in
valid
rat
e (%
)
Pan
el d
etec
tio
n s
core
a
200 parasites/µL (HRP2)200 parasites/µL (non-HRP2)2000 parasites/µL (HRP2)2000 parasites/µL (non-HRP2)False-positive Plasmodium spp. rate (%)Invalid rate (%)
98 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Figure S2: Malaria RDT performance in phase 2 of rounds 3-6 against wild-type (clinical) samples containing P. vivax at low (200) and high (2000 or 5000) parasite density (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 the minimum specified reading time, are positive. b Clean-negative - blood samples from healthy volunteers with no known current illness or blood abnormality.
100
90
80
70
60
50
40
30
20
10
0
100
80
60
40
20
0
Fals
e-p
ositi
ve Plasm
odium
sp
p.
rate
on
clea
n-ne
gativ
e sa
mp
lesb
(%)
and
inva
lid r
ate
(%)
Pan
el d
etec
tion
sco
rea
Ad
vant
age
Mal
aria
Pan
+ P
f Car
d I
R23
1025
Bio
Trac
er™
Mal
aria
P.f/
PA
N R
apid
Car
d 1
7012
Hum
asis
Mal
aria
P.f/
P.v
Ant
igen
Tes
t A
MFV
-702
5O
ne S
tep
Mal
aria
P.F
/P.V
Tes
t (C
asse
tte)
523
352
Falc
ivax
™ R
apid
Tes
t fo
r M
alar
ia P
v/P
f 503
0100
25A
dva
ntag
e P
an M
alar
ia C
ard
IR01
3025
SD
BIO
LIN
E M
alar
ia A
g 0
5FK
40P
aras
cree
n® -
Rap
id T
est
for
Mal
aria
Pan
/Pf 5
0303
0025
Nan
oSig
n M
alar
ia P
f/P
an A
g 3.
0 R
MA
P10
BIO
NO
TE M
ALA
RIA
P.f.
& P
.v. A
g R
apid
Tes
t K
it R
G19
-12
Op
tiMA
L-IT
710
024
Car
eSta
rt™
Mal
aria
HR
P2/
pLD
H (P
f/P
AN
) CO
MB
O G
0131
/G01
31-E
TS
D B
iolin
e M
alar
ia A
g P
.f/P
.v 0
5FK
80B
ioTr
acer
™ M
alar
ia P
.f/P
.v R
apid
Car
d 1
7412
Car
eSta
rt™
Mal
aria
/Pre
gnan
cy C
omb
o (p
LDH
/HR
P2/
HC
G)
G02
21A
dva
ntag
e M
al C
ard
IR22
1025
Car
eSta
rt™
Mal
aria
HR
P2/
pLD
H (P
f/P
v) C
OM
BO
G01
61/G
0161
-ET
SD
BIO
LIN
E M
alar
ia A
g P
f/ P
an 0
5FK
66S
D B
IOLI
NE
Mal
aria
Ag
P.f/
Pan
05
FK60
/05F
K63
SD
Bio
line
Mal
aria
Ag
P.f/
P.f/
P.v
05F
K12
0M
alar
ia P
f/P
an O
ne S
tep
Rap
id T
est
RT
2022
2C
areS
tart
™ M
alar
ia p
LDH
3 L
ine
Test
G01
21H
umas
is M
alar
ia P
.f/P
an A
ntig
en T
est
AM
AL-
7025
Hum
asis
Mal
aria
P.f/
P.v
Ant
igen
Tes
t A
NM
IV-7
025
Is It
… M
alar
ia P
f/P
v D
evic
e A
L030
Rap
iGE
N B
IOC
RE
DIT
Mal
aria
Ag
Pf/
Pv
(HR
PII/
pLD
H) C
40R
HA
25R
apiG
EN
BIO
CR
ED
IT M
alar
ia A
g P
f/P
an (H
RP
II/p
LDH
) C30
RH
A25
Qui
ckP
ro�l
e™ M
alar
ia P
f/P
an T
est
7106
3C
areS
tart
™ M
alar
ia H
RP
2/p
LDH
(Pf/
VO
M) C
OM
BO
G01
71/G
0171
-ET
Car
eSta
rt™
Mal
aria
Scr
een
G02
31C
areS
tart
™ M
alar
ia p
LDH
(PA
N) G
0111
EzD
x™ M
alar
ia P
an/P
f Rap
id t
est
det
ectio
n K
it R
F M
AL
001
OnS
ite M
alar
ia P
f/P
an A
g R
apid
Tes
t R
0113
CO
ne S
tep
Mal
aria
P.f/
Pan
Tes
t W
56-C
Cor
etes
ts® O
ne S
tep
Mal
aria
Pf/
Pv
Ag
Test
Dev
ice
B42
-21/
B42
-22
DIA
QU
ICK
Mal
aria
P.f/
Pan
Cas
sett
e Z
1120
0CE
Par
aHIT
- T
otal
Ver
. 1.0
(Dev
ice)
55I
C20
4-10
OnS
ite M
alar
ia P
f/P
v A
g R
apid
Tes
t R
0112
CR
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
omb
o C
ard
HR
3123
EzD
x™ M
alar
ia P
v/P
f Rap
id M
alar
ia a
ntig
en d
etec
tion
test
RK
MA
L 00
3H
iSen
s M
alar
ia A
g P
.f/V
OM
Com
bo
Car
d H
R33
23Fi
rst
Res
pon
se® M
alar
ia p
LDH
/HR
P2
Com
bo
Test
I16F
RC
Mal
aria
Pf (
HR
PII)
PV
(PLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
GM
006
Firs
t R
esp
onse
® M
alar
ia A
g P
f/P
v C
ard
Tes
t P
I19F
RC
Mer
iscr
een
Mal
aria
Pf/
Pan
Ag
MH
LRP
D-0
1B
ION
OTE
MA
LAR
IA P
.f &
Pan
Ag
Rap
id T
est
Kit
RG
19-0
8N
G-T
est
MA
LAR
IA P
f/P
an (p
LDH
) N
G-M
AL-
W23
-001
Hum
asis
Mal
aria
P.f/
Pan
Ant
igen
Tes
t A
NM
AL-
7025
Mal
eris
can®
Mal
aria
P.f/
PA
N (P
v, P
m, P
o) 3
Lin
e A
ntig
en T
est
MA
T-P
F/P
AN
-50
Par
aban
k™ D
evic
e -
Rap
id t
est
for
Mal
aria
Pan
50
3010
25Fi
rstS
ign™
- P
araV
iew
(Pan
+P
f) M
alar
ia T
est
2101
CB
-25
Par
aHIT
- T
otal
Ver
. 1.0
(Dip
stic
k) 5
5IC
203-
10C
ore™
Mal
aria
Pv/
Pf M
AL-
1900
22A
dva
nced
™ Q
ualit
y R
apid
Mal
aria
Tes
t (P
f/P
an)
ITP
1100
5Fi
rst
Res
pon
se® M
alar
ia A
g. p
LDH
/HR
P2
Com
bo
Car
d T
est
PI1
6FR
CM
alas
can™
Dev
ice
- R
apid
tes
t fo
r M
alar
ia P
f/P
an
5040
2025
Gen
Bod
y™ M
alar
ia P
f/P
an A
g M
ALA
G10
0d
iagn
ostic
ks M
ALA
RIA
(Pan
) Cas
sett
e M
PN
WB
C10
07.3
dia
gnos
ticks
MA
LAR
IA (P
an/P
f) C
asse
tte
MP
NFW
BC
1007
.4M
alar
ia P
V/P
F (p
LDH
/HR
P2)
Ant
igen
Tes
t In
f-72
KH
B® M
alar
ia A
g P
.f/P
.v R
apid
Tes
t K
H-R
-07-
50A
dvan
ced
Qua
lity™
One
Ste
p M
alar
ia (
Pf/
Pv)
Tri-
line
Test
(who
le b
lood
) ITP
1100
3 TC
40IC
T M
alar
ia D
ual T
est
ML0
3R
ight
Sig
n™ M
alar
ia P
.f/P
an R
apid
Tes
t C
asse
tte
IMP
N-C
52Tr
usty
™ M
alar
ia A
ntig
en P
.f./p
.v. t
est
A03
-12-
322
AC
CU
CA
RE
ON
E S
TEP
MA
LAR
IA P
f/P
an A
ntig
en T
est
MA
GC
25
Par
aHIT
®fV
Rap
id t
est
for
P. f
alci
par
um a
nd P
.viv
ax M
alar
ia -
Dev
ice
55IC
402-
50A
SA
N E
asy
Test
® M
alar
ia P
f/P
an A
g A
M46
50-K
Ad
vant
age
Mal
aria
Car
d I
R21
1025
Cor
e™ M
alar
ia P
an P
f MA
L-19
0024
Qui
ckP
ro�l
e™ M
alar
ia P
f/P
v Te
st 7
1050
Mer
iscr
een
Mal
aria
Pf/
Pv
Ag
MFL
RP
D-0
1A
TOM
OR
AP
ID™
MA
LAR
IA (P
F/P
AN
) MM
AL0
1IM
MU
NO
QU
ICK
CO
NTA
CT
MA
LAR
IA +
4 0
525K
25G
ened
ia® M
alar
ia P
.f/P
an A
g R
apid
Tes
t 2
0-01
46-0
1O
ne S
tep
Mal
aria
P.f/
Pan
Who
le B
lood
Tes
t W
62-C
dia
gnos
ticks
MA
LAR
IA (P
an/P
v/P
f) C
asse
tte
MP
NV
FC10
07.5
Cor
e™ M
alar
ia P
an/P
v/P
f M
AL-
1900
26M
alar
ia p
f (p
LDH
) / P
AN
-pLD
H T
est
Dev
ice
M
FV-1
24N
anoS
ign
Mal
aria
Pf/
Pv
Ag
RM
AD
10A
BO
N™
Plu
s M
alar
ia P
.f/P
an R
apid
Tes
t D
evic
e (W
hole
Blo
od) I
MA
-T40
2V
ikia
® M
alar
ia A
g P
f/P
an 4
1249
9M
eDiP
ro M
alar
ia A
g H
RP
2/p
LDH
Com
bo
IR-0
051K
Mal
aria
pf (
HR
P II
)/P
AN
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
1-13
-101
-1M
alar
ia P
f./P
an A
ntig
en (M
AL
Pf/
Pan
) Tes
t K
it A
03-1
8-32
2M
alar
ia P
f/ P
AN
GM
004
Mal
aria
pf (
HR
P II
) / (P
AN
-pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
MFV
-124
RM
alar
ia p
f (H
RP
II) /
pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
MFV
-124
VO
ne S
tep
Mal
aria
P.f/
P.v
Who
le B
lood
Tes
t W
056-
CA
ZO
G M
alar
ia p
f (H
RP
II)/p
f (LD
H)/
(PA
N-L
DH
) Ant
igen
Det
ectio
n D
evic
e M
FV-1
24F
AZ
OG
hC
G M
alar
ia D
etec
tion
Test
Dev
ice
MP
T-12
4M
alar
ia p
f (H
RP
II) /
pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
1-13
-101
-3M
alar
ia P
an T
est
MA
L-W
23N
-001
Mal
aria
Pf/
Pv
GM
002
Sum
ma
ry
ro
un
dS
1-6
98 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Figure S2: Malaria RDT performance in phase 2 of rounds 3-6 against wild-type (clinical) samples containing P. vivax at low (200) and high (2000 or 5000) parasite density (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 the minimum specified reading time, are positive. b Clean-negative - blood samples from healthy volunteers with no known current illness or blood abnormality.
100
90
80
70
60
50
40
30
20
10
0
100
80
60
40
20
0
Fals
e-p
ositi
ve Plasm
odium
sp
p.
rate
on
clea
n-ne
gativ
e sa
mp
lesb
(%)
and
inva
lid r
ate
(%)
Pan
el d
etec
tion
sco
rea
Ad
vant
age
Mal
aria
Pan
+ P
f Car
d I
R23
1025
Bio
Trac
er™
Mal
aria
P.f/
PA
N R
apid
Car
d 1
7012
Hum
asis
Mal
aria
P.f/
P.v
Ant
igen
Tes
t A
MFV
-702
5O
ne S
tep
Mal
aria
P.F
/P.V
Tes
t (C
asse
tte)
523
352
Falc
ivax
™ R
apid
Tes
t fo
r M
alar
ia P
v/P
f 503
0100
25A
dva
ntag
e P
an M
alar
ia C
ard
IR01
3025
SD
BIO
LIN
E M
alar
ia A
g 0
5FK
40P
aras
cree
n® -
Rap
id T
est
for
Mal
aria
Pan
/Pf 5
0303
0025
Nan
oSig
n M
alar
ia P
f/P
an A
g 3.
0 R
MA
P10
BIO
NO
TE M
ALA
RIA
P.f.
& P
.v. A
g R
apid
Tes
t K
it R
G19
-12
Op
tiMA
L-IT
710
024
Car
eSta
rt™
Mal
aria
HR
P2/
pLD
H (P
f/P
AN
) CO
MB
O G
0131
/G01
31-E
TS
D B
iolin
e M
alar
ia A
g P
.f/P
.v 0
5FK
80B
ioTr
acer
™ M
alar
ia P
.f/P
.v R
apid
Car
d 1
7412
Car
eSta
rt™
Mal
aria
/Pre
gnan
cy C
omb
o (p
LDH
/HR
P2/
HC
G)
G02
21A
dva
ntag
e M
al C
ard
IR22
1025
Car
eSta
rt™
Mal
aria
HR
P2/
pLD
H (P
f/P
v) C
OM
BO
G01
61/G
0161
-ET
SD
BIO
LIN
E M
alar
ia A
g P
f/ P
an 0
5FK
66S
D B
IOLI
NE
Mal
aria
Ag
P.f/
Pan
05
FK60
/05F
K63
SD
Bio
line
Mal
aria
Ag
P.f/
P.f/
P.v
05F
K12
0M
alar
ia P
f/P
an O
ne S
tep
Rap
id T
est
RT
2022
2C
areS
tart
™ M
alar
ia p
LDH
3 L
ine
Test
G01
21H
umas
is M
alar
ia P
.f/P
an A
ntig
en T
est
AM
AL-
7025
Hum
asis
Mal
aria
P.f/
P.v
Ant
igen
Tes
t A
NM
IV-7
025
Is It
… M
alar
ia P
f/P
v D
evic
e A
L030
Rap
iGE
N B
IOC
RE
DIT
Mal
aria
Ag
Pf/
Pv
(HR
PII/
pLD
H) C
40R
HA
25R
apiG
EN
BIO
CR
ED
IT M
alar
ia A
g P
f/P
an (H
RP
II/p
LDH
) C30
RH
A25
Qui
ckP
ro�l
e™ M
alar
ia P
f/P
an T
est
7106
3C
areS
tart
™ M
alar
ia H
RP
2/p
LDH
(Pf/
VO
M) C
OM
BO
G01
71/G
0171
-ET
Car
eSta
rt™
Mal
aria
Scr
een
G02
31C
areS
tart
™ M
alar
ia p
LDH
(PA
N) G
0111
EzD
x™ M
alar
ia P
an/P
f Rap
id t
est
det
ectio
n K
it R
F M
AL
001
OnS
ite M
alar
ia P
f/P
an A
g R
apid
Tes
t R
0113
CO
ne S
tep
Mal
aria
P.f/
Pan
Tes
t W
56-C
Cor
etes
ts® O
ne S
tep
Mal
aria
Pf/
Pv
Ag
Test
Dev
ice
B42
-21/
B42
-22
DIA
QU
ICK
Mal
aria
P.f/
Pan
Cas
sett
e Z
1120
0CE
Par
aHIT
- T
otal
Ver
. 1.0
(Dev
ice)
55I
C20
4-10
OnS
ite M
alar
ia P
f/P
v A
g R
apid
Tes
t R
0112
CR
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
omb
o C
ard
HR
3123
EzD
x™ M
alar
ia P
v/P
f Rap
id M
alar
ia a
ntig
en d
etec
tion
test
RK
MA
L 00
3H
iSen
s M
alar
ia A
g P
.f/V
OM
Com
bo
Car
d H
R33
23Fi
rst
Res
pon
se® M
alar
ia p
LDH
/HR
P2
Com
bo
Test
I16F
RC
Mal
aria
Pf (
HR
PII)
PV
(PLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
GM
006
Firs
t R
esp
onse
® M
alar
ia A
g P
f/P
v C
ard
Tes
t P
I19F
RC
Mer
iscr
een
Mal
aria
Pf/
Pan
Ag
MH
LRP
D-0
1B
ION
OTE
MA
LAR
IA P
.f &
Pan
Ag
Rap
id T
est
Kit
RG
19-0
8N
G-T
est
MA
LAR
IA P
f/P
an (p
LDH
) N
G-M
AL-
W23
-001
Hum
asis
Mal
aria
P.f/
Pan
Ant
igen
Tes
t A
NM
AL-
7025
Mal
eris
can®
Mal
aria
P.f/
PA
N (P
v, P
m, P
o) 3
Lin
e A
ntig
en T
est
MA
T-P
F/P
AN
-50
Par
aban
k™ D
evic
e -
Rap
id t
est
for
Mal
aria
Pan
50
3010
25Fi
rstS
ign™
- P
araV
iew
(Pan
+P
f) M
alar
ia T
est
2101
CB
-25
Par
aHIT
- T
otal
Ver
. 1.0
(Dip
stic
k) 5
5IC
203-
10C
ore™
Mal
aria
Pv/
Pf M
AL-
1900
22A
dva
nced
™ Q
ualit
y R
apid
Mal
aria
Tes
t (P
f/P
an)
ITP
1100
5Fi
rst
Res
pon
se® M
alar
ia A
g. p
LDH
/HR
P2
Com
bo
Car
d T
est
PI1
6FR
CM
alas
can™
Dev
ice
- R
apid
tes
t fo
r M
alar
ia P
f/P
an
5040
2025
Gen
Bod
y™ M
alar
ia P
f/P
an A
g M
ALA
G10
0d
iagn
ostic
ks M
ALA
RIA
(Pan
) Cas
sett
e M
PN
WB
C10
07.3
dia
gnos
ticks
MA
LAR
IA (P
an/P
f) C
asse
tte
MP
NFW
BC
1007
.4M
alar
ia P
V/P
F (p
LDH
/HR
P2)
Ant
igen
Tes
t In
f-72
KH
B® M
alar
ia A
g P
.f/P
.v R
apid
Tes
t K
H-R
-07-
50A
dvan
ced
Qua
lity™
One
Ste
p M
alar
ia (
Pf/
Pv)
Tri-
line
Test
(who
le b
lood
) ITP
1100
3 TC
40IC
T M
alar
ia D
ual T
est
ML0
3R
ight
Sig
n™ M
alar
ia P
.f/P
an R
apid
Tes
t C
asse
tte
IMP
N-C
52Tr
usty
™ M
alar
ia A
ntig
en P
.f./p
.v. t
est
A03
-12-
322
AC
CU
CA
RE
ON
E S
TEP
MA
LAR
IA P
f/P
an A
ntig
en T
est
MA
GC
25
Par
aHIT
®fV
Rap
id t
est
for
P. f
alci
par
um a
nd P
.viv
ax M
alar
ia -
Dev
ice
55IC
402-
50A
SA
N E
asy
Test
® M
alar
ia P
f/P
an A
g A
M46
50-K
Ad
vant
age
Mal
aria
Car
d I
R21
1025
Cor
e™ M
alar
ia P
an P
f MA
L-19
0024
Qui
ckP
ro�l
e™ M
alar
ia P
f/P
v Te
st 7
1050
Mer
iscr
een
Mal
aria
Pf/
Pv
Ag
MFL
RP
D-0
1A
TOM
OR
AP
ID™
MA
LAR
IA (P
F/P
AN
) MM
AL0
1IM
MU
NO
QU
ICK
CO
NTA
CT
MA
LAR
IA +
4 0
525K
25G
ened
ia® M
alar
ia P
.f/P
an A
g R
apid
Tes
t 2
0-01
46-0
1O
ne S
tep
Mal
aria
P.f/
Pan
Who
le B
lood
Tes
t W
62-C
dia
gnos
ticks
MA
LAR
IA (P
an/P
v/P
f) C
asse
tte
MP
NV
FC10
07.5
Cor
e™ M
alar
ia P
an/P
v/P
f M
AL-
1900
26M
alar
ia p
f (p
LDH
) / P
AN
-pLD
H T
est
Dev
ice
M
FV-1
24N
anoS
ign
Mal
aria
Pf/
Pv
Ag
RM
AD
10A
BO
N™
Plu
s M
alar
ia P
.f/P
an R
apid
Tes
t D
evic
e (W
hole
Blo
od) I
MA
-T40
2V
ikia
® M
alar
ia A
g P
f/P
an 4
1249
9M
eDiP
ro M
alar
ia A
g H
RP
2/p
LDH
Com
bo
IR-0
051K
Mal
aria
pf (
HR
P II
)/P
AN
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
1-13
-101
-1M
alar
ia P
f./P
an A
ntig
en (M
AL
Pf/
Pan
) Tes
t K
it A
03-1
8-32
2M
alar
ia P
f/ P
AN
GM
004
Mal
aria
pf (
HR
P II
) / (P
AN
-pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
MFV
-124
RM
alar
ia p
f (H
RP
II) /
pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
MFV
-124
VO
ne S
tep
Mal
aria
P.f/
P.v
Who
le B
lood
Tes
t W
056-
CA
ZO
G M
alar
ia p
f (H
RP
II)/p
f (LD
H)/
(PA
N-L
DH
) Ant
igen
Det
ectio
n D
evic
e M
FV-1
24F
AZ
OG
hC
G M
alar
ia D
etec
tion
Test
Dev
ice
MP
T-12
4M
alar
ia p
f (H
RP
II) /
pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
1-13
-101
-3M
alar
ia P
an T
est
MA
L-W
23N
-001
Mal
aria
Pf/
Pv
GM
002
200 parasites/µL2000 parasites/µLFalse-positive Plasmodium spp. rate (%)Invalid rate (%)
1110 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Figure S3: Panel detection score of malaria combination RDTs meeting WHO procurement criteria for false-positive and invalid rates, in phase 2 of rounds 3–6 against wild-type (clinical) samples containing P. falciparum and P. vivax at low parasite density (200 parasites/µL)
100
80
60
40
20
00 20 40 60 80 100
Panel detection score P. falciparuma
Pan
el d
etec
tion
sco
re P
. viv
axa 100
95
90
85
80
75
Panel detection score P. falciparuma
Pan
el d
etec
tion
sco
re P
. viv
axa
75 80 85 90 95 100
75 80 85 90 95 100
Panel detection score P. falciparuma
Pan
el d
etec
tion
sco
re P
. viv
axa
60
40
20
0
60
40
20
00 20 40 60
Panel detection score P. falciparuma
Pan
el d
etec
tion
sco
re P
. viv
axa
1 Core™ Malaria Pv/Pf MAL-1900222 diagnosticks MALARIA (Pan/Pf) Cassette MPNFWBC1007.43 Malaria pf (HRP II) / (PAN-pLDH) Antigen Detection Test Device MFV-124R4 SD BIOLINE Malaria Ag P.f/Pan 05FK60/05FK635 diagnosticks MALARIA (Pan/Pv/Pf) Cassette MPNVFC1007.56 ICT Malaria Dual Test ML037 NanoSign Malaria Pf/Pan Ag 3.0 RMAP108 BIONOTE MALARIA P.f.& P.v. Ag Rapid Test Kit RG19-129 RAPID 1-2-3® HEMA CASSETTE MALARIA PF/PV TEST MAL-PFV-CAS/25(100)10 Core™ Malaria Pan/Pv/Pf MAL-19002611 SD Bioline Malaria Ag P.f/P.v 05FK8012 BioTracer™ Malaria P.f/P.v Rapid Card 1741213 RapiGEN BIOCREDIT Malaria Ag Pf/Pv (HRPII/pLDH) C40RHA2514 KHB® Malaria Ag P.f/P.v Rapid Test KH-R-07-5015 CareStart™ Malaria HRP2/pLDH (Pf/Pv) COMBO G0161/G0161-ET17 SD BIOLINE Malaria Ag Pf/ Pan 05FK6618 CareStart™ Malaria HRP2/pLDH (Pf/PAN) COMBO G0131/G0131-ET19 DIAQUICK Malaria P.f/Pan Cassette Z11200CE20 Malaria PV/PF (pLDH/HRP2) Antigen Test Inf-7221 ATOMORAPID™ MALARIA (PF/PAN) MMAL0122 CareStart™ Malaria HRP2/pLDH (Pf/VOM) COMBO G0171/G0171-ET23 Humasis Malaria P.f/Pan Antigen Test AMAL-702524 HiSens Malaria Ag P.f/P.v Combo Card HR312325 HiSens Malaria Ag P.f/VOM Combo Card HR332326 Malaria Pf/Pan One Step Rapid Test RT 2022227 RapiGEN BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C30RHA2528 Humasis Malaria P.f/Pan Antigen Test ANMAL-702529 CareStart™ Malaria pLDH 3 Line Test G012130 Humasis Malaria P.f/P.v Antigen Test ANMIV-702531 Is It… Malaria Pf/Pv Device AL03032 Advanced™ Quality Rapid Malaria Test (Pf/Pan) ITP1100533 FirstSign™ - ParaView (Pan+Pf) Malaria Test 2101CB-2534 CareStart™ Malaria Screen G023135 Vikia® Malaria Ag Pf/Pan 41249936 ABON™ Plus Malaria P.f/Pan Rapid Test Device (Whole Blood) IMA-T40237 SD Bioline Malaria Ag P.f/P.f/P.v 05FK12038 First Response® Malaria pLDH/HRP2 Combo Test I16FRC39 Malaria Pf (HRPII) PV (PLDH) Antigen Detection Test Device GM00640 First Response® Malaria Ag Pf/Pv Card Test PI19FRC41 ParaHIT - Total Ver. 1.0 (Device) 55IC204-10
42 Advantage Malaria Pan + Pf Card IR23102543 CareStart™ Malaria pLDH (PAN) G011144 Maleriscan® Malaria P.f/PAN (Pv, Pm, Po) 3 Line Antigen Test MAT-PF/PAN-5045 GenBody™ Malaria Pf/Pan Ag MALAG10046 CareStart™ Malaria/Pregnancy Combo (pLDH/HRP2/HCG) G022147 BioTracer™ Malaria P.f/PAN Rapid Card 1701248 BIONOTE MALARIA P.f & Pan Ag Rapid Test Kit RG19-0849 First Response® Malaria Ag. pLDH/HRP2 Combo Card Test PI16FRC50 Malascan™ Device - Rapid test for Malaria Pf/Pan 5040202551 ASAN Easy Test® Malaria Pf/Pan Ag AM4650-K52 Falcivax™ Rapid Test for Malaria Pv/Pf 50301002553 Malaria pf (HRP II) / pv (pLDH) Antigen Detection Test Device MFV-124V54 Parascreen® - Rapid Test for Malaria Pan/Pf 50303002555 QuickProfile™ Malaria Pf/Pan Test 7106356 EzDx™ Malaria Pan/Pf Rapid test detection Kit RF MAL 00157 Coretests® One Step Malaria Pf/Pv Ag Test Device B42-21/B42-2258 QuickProfile™ Malaria Pf/Pv Test 7105059 One Step Malaria P.f/P.v Whole Blood Test W056-C60 OnSite Malaria Pf/Pan Ag Rapid Test R0113C61 Meriscreen Malaria Pf/Pan Ag MHLRPD-0162 One Step Malaria P.f/Pan Whole Blood Test W62-C63 ParaHIT - Total Ver. 1.0 (Dipstick) 55IC203-1064 EzDx™ Malaria Pv/Pf Rapid Malaria antigen detection test RK MAL 00365 Meriscreen Malaria Pf/Pv Ag MFLRPD-0166 IMMUNOQUICK CONTACT MALARIA +4 0525K2567 Advanced Quality™ One Step Malaria (Pf/Pv) Tri-line Test (whole blood) ITP11003 TC4068 OnSite Malaria Pf/Pv Ag Rapid Test R0112C69 MeDiPro Malaria Ag HRP2/pLDH Combo IR-0051K70 ACCUCARE ONE STEP MALARIA Pf/Pan Antigen Test MAGC 2571 Malaria pf (HRP II)/PAN (pLDH) Antigen Detection Test Device 1-13-101-172 ParaHIT®fV Rapid test for P. falciparum and P. vivax Malaria - Device 55IC402-5073 AZOG Malaria pf (HRPII)/pf (LDH)/ (PAN-LDH) Antigen Detection Device MFV-124F74 AZOG hCG Malaria Detection Test Device MPT-12475 Malaria Pf./Pan Antigen (MAL Pf/Pan) Test Kit A03-18-32276 Malaria pf (HRP II) / pv (pLDH) Antigen Detection Test Device 1-13-101-377 Malaria Pf/Pv GM00278 Malaria Pf/ PAN GM00479 One Step Malaria P.f/Pan Test W56-C80 Advantage Mal Card IR22102581 Humasis Malaria P.f/P.v Antigen Test AMFV-7025
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.
Sum
ma
ry
ro
un
dS
1-6
1110 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Table S1: Product resubmissions: WHO malaria RDT product testing rounds 1—6
Manufacturer Product name Product code
Product re-submission
Round
Voluntary Compulsory
Access Bio, Inc.
CareStart™ Malaria HRP2/pLDH (Pf/Pv) COMBO G0161/G0161-ET 2, 4CareStart™ Malaria HRP2/pLDH (Pf/VOM) COMBO G0171/G0171-ET 2, 4CareStart™Malaria HRP2 (Pf) G0141/G0141-ET 1 5CareStart™ Malaria HRP2/pLDH (Pf/PAN) Combo G0131/G0131-ET 1 5CareStart™Malaria pLDH (PAN) G0111 1 5CareStart™Malaria HRP2/pLDH (Pf) G0181/G0181-ET 2 6
Advy Chemical Pvt. Ltd. (Affiliate of Bharat Serums & Vaccines Ltd. ) EzDx™ Malaria Pan/Pf Rapid Test Detection Kit RK MAL 001 4, 5, 6
ARKRAY Healthcare Pvt. Ltd.aParaHIT® - f (Device)b 55IC102-10 1, 3ParaHIT® - f (Dipstick)c 55IC101-10 1, 3
AZOGMalaria pf (HRP II) / (PAN-LDH) Antigen Detection Test Deviced MFV-124R 1, 3Malaria pf (pLDH) / PAN-pLDH Test Device MFV-124 3, 5
Bhat Bio-Tech India (P) Ltd. Maleriscan® Malaria Pf/PAN (Pv, Pm, Po) 3 Line Antigen Test MAT-PF/PAN-50 4, 5Bioland NanoSign Malaria Pf/Pan Ag RMAP10 3, 4
Bionote, Inc.BIONOTE MALARIA P.f. Ag Rapid Test Kit RG19-11 3, 6BIONOTE MALARIA P.f & Pan Ag Rapid Test Kit RG19-08 3, 6
Biosynex IMMUNOQUICK® MALARIA falciparum 0502_K25 1 5Bio Focus Co., Ltd. BioTracer™ Malaria P.f/PAN Rapid Card 17012 5, 6
Blue Cross Bio-Medical (Beijing) Co., Ltd.One Step Malaria Pf Test (cassette) 522352 2, 3, 4One Step Malaria P.F/P.V Test (Cassette) 523352 4, 5
CTK Biotech, Inc.Onsite Pf Ag Rapid Test R0114C 2, 3, 6Onsite Malaria Pf/Pan Malaria Ag Rapid Test R0113C 2, 3, 4, 5, 6Onsite Malaria Pf/Pv Ag Rapid Test R0112C 2, 3, 4, 6
DiaMed - A Division of Bio-Rad OptiMAL-IT 710024 1, 3
Guangzhou Wondfo Biotech Co. Ltd.Wondfo One Step Malaria Pf/Pan Whole Blood Test W56-C 1, 3One Step Malaria P.f/P.v Whole Blood Test W056-C 5, 6One Step Malaria P.f Teste W37-C 2, 3, 4, 6
Humasis Co., Ltd. Humasis Malaria Pf/Pan Antigen Test AMAL-7025 4, 5
ICT INTERNATIONALICT Malaria Combo Cassette Test ML02 1, 3, 4ICT Malaria Pf Cassette Test ML01 1, 3ICT Malaria Dual Test ML03 3, 5
InTec Products, Inc.Advanced Quality™ One Step Malaria Pf Test ITP11002TC1/TC40 1, 3 5Advanced Quality™ One Step Malaria (Pf/Pv) Tri-line Test (whole blood) ITP11003 TC40 3, 6
J.Mitra & Co. Pvt. Ltd.Advantage Pan Malaria Card IR013025 1 5Advantage Mal Card IR221025 1 5Advantage P.f Malaria Card IR016025 1 5
Orchid Biomedical SystemsParacheck® Pf Device - Rapid test for P. falciparum Malaria (Ver. 3)f 30301025 1, 3, 4Paracheck® Pf Dipstick - Rapid test for P. falciparum Malaria (Ver.3)f 30302025 1, 3, 4
Premier Medical Corporation Ltd. First Response® Malaria Ag Combo (pLDH/HRP2)g I16FRC25 1, 2, 5First Response® Malaria Ag P. falciparum (HRP2) Card Test I13FRC25 1 5
RapiGEN Inc. RapiGEN BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C30RHA25 5, 6SSA Diagnostics & Biotech Systems diagnosticks- Malaria (Pf)Cassette WB KMFC6001 2, 5
Standard Diagnostics Inc.
SD BIOLINE Malaria Ag 05FK40 1, 3SD BIOLINE Malaria Ag Pf/Pan 05FK60 1, 3, 5SD BIOLINE Malaria Antigen 05FK50 1 5SD Bioline Malaria Ag P.f (HRP2/pLDH) 05FK90 3, 6SD Bioline Malaria Ag P.f/P.v 05FK80 2 6
Unimed International Inc. FirstSign™ - ParaView (Pan+Pf) Malaria Test 2101 CB-25 2, 4
Vision Biotech (Pty) Ltd / Orgenics (Alere Healthcare (Pty) Ltd subsidaries)
Malaria Rapid Combo/Clearview® Malaria Combo VB11h 1, 3Malaria Rapid Pf /Clearview® Malaria Pf VB01 1, 3, 5Malaria Rapid Dual/Clearview® Malaria Dual Test Device VB20h 1, 3, 5
Zephyr Biomedical Systems
Malascan™ Device - Rapid test for Malaria Pf/Pan 50402025 1, 3Parabank™ Device - Rapid test Malaria Pan 50301025 1, 3
Parascreen™ Device - Rapid test for Malaria Pan/Pf 50310025; 503030025 (rd 6) 1, 3, 4, 5, 6
Falcivax™ Rapid Test for Malaria Pv/Pf (device) 50300025; 503010025 (rd 6) 2, 4, 6
a Span Diagnostics Ltd. is now ARKRAY Healthcare Pvt.Ltd. b In round 1 product name and catalogue number was Parahit-f TEST DEVICE FOR FALCIPARUM MALARIA (25975)c In round 1 product name and catalogue number was Parahit-f DIPSTICK FOR FALCIPARUM MALARIA (25977)d Round 1 product name error : published - Malaria Pf (HRPII)/pv-LDH) Antigen Detection Test Device Code; corrected product name: Malaria Pf (HRPII/PAN-LDH) Antigen
Detection Test Device Code. No change in product code.e In round 2, product did not pass phase 1, therefore results do not feature in summary tables. f Ver.3 was introduced after round 1g Error in WHO Malaria RDT product testing: round 1 report: product code (II6FRC30) should have been ( I16FRC ), as in round 2h New company acquisition (Alere™), therefore change in product branding and catalogue numbers; VB011 to VB11 and VB020 to VB20. Manufacturer confirmed
compliance with product definition.
1312 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Tabl
e S2
: Mal
aria
RDT
pha
se-2
per
form
ance
in r
ound
s 3–
6 ag
ains
t w
ild-t
ype
(clin
ical
) sa
mpl
es c
onta
inin
g P.
falc
ipar
um (
Pf)
and
P. v
ivax
(Pv
) at
low
(200
)
and
high
(200
0 or
500
0) p
aras
ite
dens
ity
(par
asit
es/μ
L) a
nd c
lean
-neg
ativ
e sa
mpl
es
Prod
uct
Prod
uct
code
Man
ufac
ture
r
Pane
l det
ectio
n sc
orea
False
-pos
itive
rat
es (%
)To
tal f
alse
-pos
itive
ra
tesb
(%)
Inva
lid
rate
(%
)lRo
und
Mee
ts
WH
O
proc
urem
ent
crite
ria
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
False
-po
sitiv
e
non-
Pf
infe
ctio
ne
False
-po
sitiv
e
Pf
infe
ctio
nf
False
-po
sitiv
e
non-
Pf
infe
ctio
ng
False
-po
sitiv
e
Pf
infe
ctio
nh
False
-pos
itive
Pl
asm
odiu
m sp
p.
Infe
ctio
ni
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
td32
.7N
A99
.0N
AN
A0
NA
0.0
0.4
0.0
4N
oAd
vanc
ed Q
ualit
y™ O
ne S
tep
Mal
aria
Pf T
est
ITP11
002T
C1/TC
40In
Tec
Prod
ucts
, Inc
.53
.0N
A93
.0N
AN
A3.
6N
A5.
77.
7 (2
33)
0.4
5N
oAd
vant
age
P.f.
Mal
aria
Car
dIR
0160
25J.
Mitr
a &
Co.
Pvt
. Ltd
.89
.0N
A99
.0N
AN
A0.
7N
A0.
00.
00.
05
Yes
BION
OTE
MAL
ARIA
P.f.
Ag
Rapi
d Te
st K
itjRG
19-1
1Bi
onot
e,In
c.88
.0N
A10
0.0
NA
NA
0.0
NA
0.0
0.5
0.0
6Ye
sCa
reSt
art™
Mal
aria
HRP
2 (P
f)G0
141m
/G01
41-E
TAc
cess
Bio
, Inc
.91
.0N
A10
0.0
NA
NA
0.0
NA
0.0
0.9
0.0
5Ye
sm
Care
Star
t™ M
alar
ia H
RP2/
pLDH
Pf t
estj
G018
1m/G
0181
-ET
Acce
ss B
io, I
nc.
91.0
NA
99.0
NA
NA
0.7
NA
0.0
0.0
0.0
6Ye
sm
Core
™ M
alar
ia P
f M
AL-1
9002
0Co
re D
iagn
ostic
s97
.0N
A10
0.0
NA
NA
0.0
NA
0.0
1.0
(198
)0.
33
Yes
EzDx
™ M
alar
ia P
f Rap
id M
alar
ia a
ntig
en d
etec
tion
test
RK M
AL 0
08Ad
vy C
hem
ical
Priv
ate
Lim
ited
71.0
NA
100.
0N
AN
A1.
4N
A1.
41.
00.
16
No
Firs
t Res
pons
e® M
alar
ia A
g P.
falc
ipar
um (H
RP2)
Car
d Te
stI1
3FRC
25Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
95.0
NA
100.
0N
AN
A0.
7N
A0.
00.
40.
05
Yesm
Firs
t Res
pons
e® M
alar
ia A
g P.
falc
ipar
um (H
RP2)
Car
d Te
stPI
13FR
CPr
emie
r Med
ical
Cor
pora
tion
Ltd.
91.0
NA
100.
0N
AN
A0.
0N
A0.
01.
00.
06
Yes
Firs
tSig
n™ M
alar
ia P
f21
00CB
-25
Uni
med
Inte
rnat
iona
l Inc
.94
.9N
A10
0.0
NA
NA
0.7
NA
1.5
2.2
(231
)0.
24
Yes
Hum
asis
Mal
aria
P.f
Antig
en T
est
ANM
PF-7
025
Hum
asis
Co.
, Ltd
.87
.0N
A10
0.0
NA
NA
1.4
NA
1.4
1.4
0.0
6Ye
sIC
T Di
agno
stic
s M
alar
ia P
.f.M
L01
ICT
INTE
RNAT
ION
AL86
.9N
A98
.0N
AN
A0.
0N
A0.
00.
00.
03
Yes
IMM
UN
OQU
ICK
CON
TACT
falc
ipar
um
0519
K25
Bios
ynex
81.8
NA
100.
0N
AN
A3.
6 (1
39)
NA
1.4
4.0
(199
)0.
33
Yes
IMM
UN
OQU
ICK®
MAL
ARIA
falc
ipar
um05
02_K
25Bi
osyn
ex72
.0N
A93
.0N
AN
A3.
6N
A4.
35.
1 (2
34)
0.2
5N
oKH
B® M
alar
ia A
g P.
f Rap
id T
est
KH-R
-06-
20
Shan
ghai
Keh
ua B
io-e
ngin
eerin
g Co
.,Ltd
.79
.0N
A91
.8 (9
8)N
AN
A11
.4N
A12
.910
.6 (2
35)
0.7
5N
oM
alar
ia A
ntig
en T
est-
PfM
AG01
040
Osca
r Med
icar
e Pv
t. Lt
d.91
.0N
A10
0.0
NA
NA
1.4
NA
1.4
1.0
0.0
6Ye
sM
aler
isca
n ®
Mal
aria
P.f
Antig
en T
est
MAT
-PF-
50Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
83.7
NA
98.0
NA
NA
1.5
NA
0.0
0.4
0.2
4Ye
sN
anoS
ign
Mal
aria
Pf A
g RM
AF10
Biol
and,
Ltd
84.9
NA
100.
0N
AN
A0.
0N
A0.
00.
00.
33
Yes
One
Step
Mal
aria
P.f
Who
le b
lood
Tes
tjW
37-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
., Lt
d.85
.0N
A99
.0N
AN
A0.
0N
A0.
00.
00.
06
Yes
One
Step
Mal
aria
P.F
Tes
t (Ca
sset
te)
5223
52Bl
ue C
ross
Bio
-Med
ical (
Beiji
ng) C
o., L
td.
94.9
NA
99.0
NA
NA
0N
A1.
51.
30.
04
Yes
OnSi
te M
alar
ia P
f Ag
Rapi
d Te
stj
R011
4CCT
K Bi
otec
h, In
c.75
.0N
A99
.0N
AN
A0.
0N
A0.
00.
00.
26
Yes
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipa
rum
Mal
aria
Dev
ice
(Ver
.3)
3020
3002
5Or
chid
Bio
med
ical
Sys
tem
s 95
.9N
A98
.0N
AN
A0
NA
0.0
1.3
0.0
4Ye
sPa
rach
eck®
Pf-
Rapi
d Te
st fo
r P. f
alcip
arum
Mal
aria
Dip
stic
k (Ve
r.3)j
3020
4002
5Or
chid
Bio
med
ical
Sys
tem
s 70
.4N
A99
.0N
AN
A0
NA
0.0
0.9
0.0
4N
oPa
raH
IT®
- f
Ver.
1 (D
evic
e)55
IC10
4-50
ARKR
AY H
ealth
care
Pvt
. Ltd
.n84
.9N
A10
0.0
NA
NA
0.0
NA
0.0
0.0
0.0
3Ye
sm
Para
HIT
® -
f Ver
. 1 (D
ipst
ick)
55IC
103-
50AR
KRAY
Hea
lthca
re P
vt. L
td.n
80.8
NA
99.0
NA
NA
0.0
NA
1.4
2.5
0.0
3Ye
sm
Rapi
d 1-
2-3®
Hem
a® C
asse
tte
Mal
aria
PF
MAL
-PF-
CAS/
25 (1
00)
Hem
a Di
agno
stic
Sys
tem
s93
.0N
A10
0.0
NA
NA
2.9
(139
)N
A0.
00.
00.
26
Yes
Rapi
GEN
BIO
CRED
IT M
alar
ia A
g Pf
(HRP
II)C1
0RH
A25
Rapi
GEN
Inc.
88.0
NA
99.0
NA
NA
0.7
NA
0.0
0.5
(207
)0.
26
Yes
Righ
tSig
n® M
alar
ia P
.f. R
apid
Tes
t Cas
sett
e (W
hole
Blo
od)
IMPF
-C51
Han
gzho
u Bi
otes
t Bio
tech
Co.
, Ltd
.79
.0N
A10
0.0
NA
NA
0.0
NA
0.0
0.0
0.0
6Ye
sSD
Bio
line
Mal
aria
Ag
P.f (
HRP
2/pL
DH)j,k
05FK
90St
anda
rd D
iagn
ostic
s, In
c.88
.0N
A10
0.0
NA
NA
0.7
NA
0.0
0.0
0.0
6Ye
sm
SD B
IOLI
NE
Mal
aria
Ag
Pf05
FK50
Stan
dard
Dia
gnos
tics,
Inc.
95.0
NA
99.0
NA
NA
0.0
NA
2.9
0.0
0.0
5Ye
sm
Trus
ty™
Mal
aria
Ant
igen
P.f.
test
A03-
01-3
22Ar
tron
Lab
orat
orie
s In
c.88
.8N
A10
0.0
NA
NA
4.4
(135
)N
A2.
95.
2 (2
30)
0.7
4Ye
sPf
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
85.7
5.9
100.
097
.10.
00.
00.
00.
00.
40.
04
No
ACCU
CARE
ON
E ST
EP M
ALAR
IA P
f/Pa
n An
tigen
Tes
tM
AGC
25LA
B-CA
RE D
iagn
ostic
s (In
dia)
PVT
. LTD
.66
.037
.192
.097
.10.
30.
0 (1
39)
0.0
(199
)0.
07.
3 (2
34)
0.4
5N
oAd
vanc
ed Q
ualit
y™ R
apid
Mal
aria
Tes
t (Pf
/Pan
) IT
P110
05In
Tec
Prod
ucts
, Inc
.88
.060
.010
0.0
97.1
0.3
(389
)6.
7 (1
34)
0.0
(197
)1.
48.
7 (2
31)
2.1
5N
oAd
vant
age
Mal
Car
dIR
2210
25J.
Mitr
a &
Co.
Pvt
. Ltd
.30
.094
.394
.097
.11.
50.
70.
50.
00.
40.
05
No
Adva
ntag
e M
alar
ia P
an +
Pf C
ard
IR23
1025
J. M
itra
& C
o. P
vt. L
td.
84.0
100.
010
0.0
100.
03.
50.
00.
00.
0 (6
9)0.
00.
25
Yes
ATOM
ORAP
ID™
MAL
ARIA
(PF/
PAN
)M
MAL
01At
omo
Diag
nost
ics
PTY
Lim
ited
90.0
22.9
100.
097
.10.
0 (3
99)
2.9
0.0
0.0
0.0
(207
)0.
26
No
Sum
ma
ry
ro
un
dS
1-6
1312 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Prod
uct
Prod
uct
code
Man
ufac
ture
r
Pane
l det
ectio
n sc
orea
False
-pos
itive
rat
es (%
)To
tal f
alse
-pos
itive
ra
tesb
(%)
Inva
lid
rate
(%
)lRo
und
Mee
ts
WH
O
proc
urem
ent
crite
ria
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
False
-po
sitiv
e
non-
Pf
infe
ctio
ne
False
-po
sitiv
e
Pf
infe
ctio
nf
False
-po
sitiv
e
non-
Pf
infe
ctio
ng
False
-po
sitiv
e
Pf
infe
ctio
nh
False
-pos
itive
Pl
asm
odiu
m sp
p.
Infe
ctio
ni
AZOG
Mal
aria
pf (
HRPI
I)/pf
(LDH
)/ (P
AN-L
DH) A
ntig
en D
etec
tion
Devic
ekM
FV-1
24F
AZOG
, IN
C.62
.20.
098
.088
.20.
0 (3
90)
5.2
0.0
0.0
1.7
(231
)0.
34
No
BION
OTE
MAL
ARIA
P.f
& P
an A
g Ra
pid
Test
Kitj
RG19
-08
BioN
ote,
Inc.
83.0
68.6
100.
010
0.0
0.0
0.0
0.0
0.0
0.5
0.0
6N
oBi
oTra
cer™
Mal
aria
P.f/
PAN
Rap
id C
ardj
1701
2Bi
o Fo
cus
Co.,
Ltd.
83.0
100.
010
0.0
100.
04.
00.
00.
00.
00.
00.
06
Yes
Care
Star
t™ M
alar
ia/P
regn
ancy
Com
bo (p
LDH
/HRP
2/H
CG)
G02
21Ac
cess
Bio
, Inc
.83
.894
.310
0.0
97.1
2.3
1.4
(139
)0.
0 (1
94)
1.4
0.0
0.2
3Ye
sCa
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/PA
N) C
OMBO
G013
1m/G
0131
-ET
Acce
ss B
io, I
nc.
90.0
94.3
100.
010
0.0
1.5
0.7
0.0
0.0
0.4
0.0
5Ye
sm
Care
Star
t™ M
alar
ia p
LDH
3 L
ine
Test
G
0121
Acce
ss B
io, I
nc.
88.9
91.4
100.
010
0.0
1.3
0.7
6.1
0.0
0.5
0.0
3Ye
sCa
reSt
art™
Mal
aria
Scr
een
G02
31Ac
cess
Bio
, Inc
.86
.988
.610
0.0
100.
01.
82.
10.
00.
02.
5 (1
99)
0.1
3Ye
sCo
re™
Mal
aria
Pan
Pf
MAL
-190
024
Core
Dia
gnos
tics
Ltd.
99.0
26.5
100.
029
.40.
033
.80.
042
.732
.2 (2
30)
0.3
4N
odi
agno
stic
ks M
ALAR
IA (P
an/P
f) Ca
sset
te
MPN
FWBC
1007
.4SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
s98
.051
.410
0.0
97.1
0.0
(394
)0.
00.
00.
0 (6
9)2.
50.
33
No
DIAQ
UIC
K M
alar
ia P
.f/Pa
n Ca
sset
teZ1
1200
CEDI
ALAB
Gm
bH90
.082
.910
0.0
97.1
0.3
2.9
0.0
1.5
(67)
2.1
0.2
5Ye
sEz
Dx™
Mal
aria
Pan
/Pf R
apid
test
det
ectio
n Ki
tjRK
MAL
001
Advy
Che
mic
al P
rivat
e Li
mite
d78
.088
.610
0.0
100.
00.
30.
00.
00.
01.
40.
06
Yes
Firs
t Res
pons
e® M
alar
ia A
g. p
LDH
/HRP
2 Co
mbo
Car
d Te
stI1
6FRC
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.85
.074
.310
0.0
100.
00.
30.
00.
00.
00.
00.
05
No
Firs
t Res
pons
e® M
alar
ia A
g. p
LDH
/HRP
2 Co
mbo
Car
d Te
stPI
16FR
CPr
emie
r Med
ical
Cor
pora
tion
Ltd.
82.0
91.4
100.
010
0.0
1.5
0.0
0.0
0.0
1.9
(207
)0.
16
Yes
Firs
tSig
n™ P
araV
iew
(Pan
+Pf)
2101
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
87.8
61.8
100.
010
0.0
0.3
1.5
0.0
0.0
2.6
0.0
4N
oG
enBo
dy™
Mal
aria
Pf/
Pan
AgM
ALAG
100
Gen
Body
Inc.
84.0
54.3
100.
097
.10.
00.
00.
00.
00.
0 (2
35)
0.2
5N
oG
ened
ia®
Mal
aria
P.f/
Pan
Ag R
apid
Tes
t 20
-014
6-01
Gree
n Cr
oss M
edica
l Scie
nce C
orp.
(Kor
ea)
67.0
17.1
96.0
88.6
0.0
13.6
0.0
7.1
10.6
0.1
5N
oH
umas
is M
alar
ia P
.f/Pa
n An
tigen
Tes
tjAM
AL-7
025
Hum
asis,
Co.
, Ltd
.90
.091
.410
0.0
97.1
0.5
(396
)0.
0 (1
38)
0.0
(199
)1.
40.
9 (2
35)
0.7
5Ye
sH
umas
is M
alar
ia P
.f/Pa
n An
tigen
Tes
tAN
MAL
-702
5H
umas
is C
o., L
td.
89.0
62.9
99.0
97.1
0.0
0.7
(139
)0.
01.
40.
50.
16
No
ICT
Mal
aria
Dua
l Tes
tM
L03
ICT
INTE
RNAT
ION
AL93
.040
.098
.094
.30.
34.
30.
52.
93.
00.
05
No
IMM
UN
OQU
ICK
CON
TACT
MAL
ARIA
+4
0525
K25
Bios
ynex
75.8
17.1
98.0
94.3
1.8
(395
)5.
1 (1
38)
0.0
0.0
2.0
0.3
3N
oIs
It…
Mal
aria
Pf/
Pv D
evic
eAL
030
Med
sour
ce O
zone
Bio
med
ical
s88
.091
.499
.010
0.0
0.5
(395
)0.
00.
00
(68)
1.0
(206
)0.
86
Yes
Mal
aria
Pan
Tes
t M
AL-W
23N-
001
Dim
a • G
esell
scha
ft fü
r Dia
gnos
tika m
bH54
.60.
097
.048
.62.
815
.70.
017
.144
.00.
03
No
Mal
aria
Pf./
Pan
Antig
en (M
AL P
f/Pa
n) T
est K
itA0
3-18
-322
Artr
on L
abor
ator
ies
Inc.
61.0
2.9
95.0
97.1
0.0
(3.9
8)4.
30.
0 (1
99)
0.0
0.9
0.2
5N
oM
alar
ia p
f (H
RP II
) / (P
AN-p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
eM
FV-1
24R
AZOG
, Inc
.95
.00.
010
0.0
94.3
0.0
(395
)7.
98.
10.
05.
5 (1
99)
0.3
3N
oM
alar
ia p
f (H
RP 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
No
Mal
aria
pf (
pLDH
) / P
AN-p
LDH
Tes
t Dev
ice
MFV
-124
AZOG
, Inc
.41
.08.
697
.045
.722
.547
.91.
535
.781
.3 (2
35)
0.1
5N
oM
alar
ia P
f/ P
ANG
M00
4Ge
nom
ix M
olec
ular
Dia
gnos
tics P
vt.Lt
d.39
.82.
994
.997
.10.
30.
70.
00.
00.
00.
04
No
Mal
aria
Pf/
Pan
One
Step
Rap
id T
est
RT 2
0222
Zhej
iang
Orie
nt G
ene
Biot
ech
Co., L
td.
89.0
91.4
100.
010
0.0
0.0
(398
)0.
7 (1
38)
0.0
(199
)0.
0 (6
9)0.
4 (2
32)
1.0
5Ye
sM
alas
can™
Dev
ice
- Ra
pid
test
for M
alar
ia P
f/Pa
n50
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
3N
oM
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
No
Mer
iscr
een
Mal
aria
Pf/
Pan
Ag
MH
LRPD
-01
Mer
il Di
agno
stic
s Pr
ivat
e Lt
d.77
.071
.410
0.0
100.
01.
30.
00.
00.
00.
50.
06
No
Nan
oSig
n M
alar
ia p
f/pa
n Ag
3.0
RMAP
10Bi
olan
d, L
td.
92.9
97.1
100.
010
0.0
0.8
0.0
0.0
0.0
0.4
0.0
4Ye
sN
anoS
ign
Mal
aria
Pf/
Pv A
gRM
AD10
Biol
and,
Ltd
6.1
8.6
89.9
100.
00.
50.
0 (1
39)
0.0
0.0
0.0
0.1
3N
oN
G-T
est M
ALAR
IA P
f/Pa
n (p
LDH
)NG
-MAL
-W23
-001
SARL
NG
Bio
tech
, Z.A
.90
.065
.710
0.0
94.3
0.5
(399
)9.
30.
04.
315
.30.
15
No
One
Step
Mal
aria
P.f/
Pan
Test
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
No
One
Step
Mal
aria
P.f/
Pan
Who
le B
lood
Tes
tW
62-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
., Lt
d.77
.014
.310
0.0
100.
00.
00.
00.
00.
00.
00.
06
No
OnSi
te M
alar
ia P
f/Pa
n Ag
Rap
id T
estj
R011
3CCT
K Bi
otec
h, In
c.78
.085
.799
.097
.10.
0 (3
98)
0.0
0.5
1.4
0.0
(207
)0.
26
Yes
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
3N
oPa
raH
IT -
Tot
al V
er. 1
.0 (D
evic
e)55
IC20
4-10
ARKR
AY H
ealth
care
Pvt
. Ltd
.n84
.782
.499
.091
.20.
30.
00.
53.
0 (6
7)0.
00.
14
Yes
Para
HIT
- T
otal
Ver
. 1.0
(Dip
stic
k)55
IC20
3-10
ARKR
AY H
ealth
care
Pvt
. Ltd
.n76
.561
.810
0.0
94.1
0.8
0.0
0.0
1.5
0.0
0.0
4N
oPa
rasc
reen
® -
Rapi
d Te
st fo
r Mal
aria
Pan
/Pfj
5030
3002
5Ze
phyr
Bio
med
ical
s79
.097
.110
0.0
100.
02.
30.
00.
00.
00.
00.
06
Yes
Quic
kPro
file™
Mal
aria
Pf/
Pan
Test
7106
3Lu
miq
uick
Dia
gnos
tics,
Inc.
79.0
91.4
99.0
100.
06.
51.
40.
5 (1
99)
0.0
7.2
0.1
6Ye
s
Tabl
e S2
(con
tinue
d)
(con
tinue
d)
1514 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Prod
uct
Prod
uct
code
Man
ufac
ture
r
Pane
l det
ectio
n sc
orea
False
-pos
itive
rat
es (%
)To
tal f
alse
-pos
itive
ra
tesb
(%)
Inva
lid
rate
(%
)lRo
und
Mee
ts
WH
O
proc
urem
ent
crite
ria
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
False
-po
sitiv
e
non-
Pf
infe
ctio
ne
False
-po
sitiv
e
Pf
infe
ctio
nf
False
-po
sitiv
e
non-
Pf
infe
ctio
ng
False
-po
sitiv
e
Pf
infe
ctio
nh
False
-pos
itive
Pl
asm
odiu
m sp
p.
Infe
ctio
ni
Rapi
GEN
BIO
CRED
IT M
alar
ia A
g Pf
/Pan
(HRP
II/pL
DH)
C30R
HA2
5Ra
piG
EN In
c.90
.091
.410
0.0
94.3
0.0
(399
)0.
00.
02.
92.
4 (2
07)
0.1
6Ye
sRi
ghtS
ign™
Mal
aria
P.f.
/Pan
Rap
id T
est C
asse
tte
IMPN
-C52
Han
gzho
u Bi
otes
t Bio
tech
Co.
Ltd
.74
.040
.094
.088
.62.
02.
90.
55.
714
.00.
05
No
SD B
IOLI
NE
Mal
aria
Ag
P.f/
Pan
05FK
60St
anda
rd D
iagn
ostic
s In
c.94
.091
.499
.097
.10.
80.
70.
51.
40.
00.
05
Yesm
SD B
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
)0.
0 (1
95)
0.0
(67)
1.3
(226
)2.
84
Yes
SD B
IOLI
NE
Mal
aria
Ag
05FK
40St
anda
rd D
iagn
ostic
s In
c.16
.297
.193
.910
0.0
0.8
0.0
0.0
0.0
0.0
0.0
3N
oVi
kia®
Mal
aria
Ag
Pf/P
an41
2499
IMAC
CESS
S.A
.S86
.05.
797
.094
.30.
00.
7 (1
39)
0.5
(199
)0.
0 (6
9)1.
3 (2
35)
0.3
5N
oPf
and
Pv/
Pvom
Adva
nced
Qua
lity ™
One S
tep
Mal
aria
(Pf
/Pv)
Tri-l
ine T
est (
who
le bl
ood)
jIT
P110
03 T
C40
InTe
c Pr
oduc
ts, I
nc.
74.0
48.6
100.
010
0.0
0.0
(396
)0.
00.
0 (1
99)
0.0
(69)
0.0
(207
)0.
76
No
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
No
ASAN
Eas
y Te
st®
Mal
aria
Pf/
Pan
AgAM
4650
-KAS
AN P
harm
aceu
tical
Co.
, Ltd
81
.034
.399
.010
0.0
16.5
0.0
85.5
0.0
0.4
(235
)0.
25
No
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
3Ye
sBi
oTra
cer™
Mal
aria
P.f/
P.v
Rapi
d Ca
rd17
412
Bio
Focu
s Co
., Lt
d.91
.094
.310
0.0
100.
00.
00.
00.
00.
0 (6
9)0.
00.
16
Yes
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/
Pv) C
OMBO
G016
1m/G
0161
-ET
Acce
ss B
io, I
nc.
90.8
94.1
100.
010
0.0
0.3
0.0
1.0
1.5
0.0
0.0
4Ye
sm
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) COM
BOG0
171/
G017
1-ET
Acce
ss B
io, I
nc.
89.8
91.2
100.
010
0.0
0.3
0.7
0.5
2.9
0.0
0.0
4Ye
sCo
re™
Mal
aria
Pv/
PfM
AL-1
9002
2Co
re D
iagn
ostic
s98
.060
.010
0.0
97.1
0.3
0.0
0.0
0.0
4.0
0.1
3N
oCo
rete
sts®
One
Ste
p M
alar
ia P
f/Pv
Ag
Test
Dev
ice
B42-
21/B
42-2
2Co
re T
echn
olog
y Co
., Lt
d.78
.082
.998
.010
0.0
2.8
(399
)0.
0 (1
38)
1.0
0.0
0.0
(207
)0.
56
Yes
EzDx
™ M
alar
ia P
v/Pf
Rap
id M
alar
ia a
ntig
en d
etec
tion
test
RK M
AL 0
03Ad
vy C
hem
ical
Priv
ate
Lim
ited
76.0
77.1
100.
010
0.0
1.3
1.4
0.0
1.4
3.9
0.0
6Ye
sFa
lciV
ax™
- R
apid
Tes
t for
Mal
aria
Pv/
Pfj
5030
1002
5Ze
phyr
Bio
med
ical
s80
.010
0.0
99.0
100.
00.
50.
00.
50.
01.
40.
06
Yes
Firs
t Res
pons
e® M
alar
ia A
g Pf
/Pv
Card
Tes
tPI
19FR
CPr
emie
r Med
ical
Cor
pora
tion
Ltd.
85.0
71.4
100.
010
0.0
0.0
0.0
0.0
(199
)0.
00.
5 (2
07)
0.2
6N
oH
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
4Ye
sH
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
Yes
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
Yes
Hum
asis
Mal
aria
P.f/
P.v
Antig
en T
est
ANM
IV-7
025
Hum
asis,
Co.
, Ltd
.88
.091
.410
0.0
100.
00.
30.
70.
00.
01.
0 (2
07)
0.1
6Ye
sKH
B® M
alar
ia A
g P.
f/P.
v Ra
pid
Test
KH-R
-07-
50Sh
angh
ai K
ehua
Bio
-eng
inee
ring
Co., L
td.
91.0
48.6
100.
010
0.0
0.3
0.0
0.0
0.0
0.0
0.0
6N
oM
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.
60
.20.
092
.926
.50.
50.
0 (1
35)
3.1
(195
)1.
50.
0 (2
30)
0.5
4N
oM
alar
ia p
f (H
RP II
) / p
v (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e M
FV-1
24V
AZOG
, Inc
.79
.80.
010
0.0
20.0
0.0
1.4
0.0
0.0
0.0
(199
)0.
13
No
Mal
aria
Pf (
HRP
II)/ P
V (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e G
M00
6Ge
nom
ix M
olec
ular
Dia
gnos
tics P
vt. L
td.
85.0
74.3
97.0
94.3
1.5
(391
)6.
5 (1
38)
3.6
(195
)2.
90.
9 (2
32)
2.5
5N
oM
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
4N
oM
alar
ia P
V/PF
(pLD
H/H
RP2)
Ant
igen
Tes
t In
f-72
Nan
tong
Ege
ns B
iote
chno
logy
Co.
, Ltd
.90
.051
.410
0.0
97.1
0.0
(395
)0.
0 (1
37)
0.5
(198
)0.
00.
0 (2
03)
1.3
6N
oM
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
) Ltd
.84
.062
.910
0.0
100.
027
.3 (3
99)
5.8
(139
)87
.4 (1
99)
4.3
(69)
3.0
(232
)0.
75
No
Mer
iscr
een
Mal
aria
Pf/
Pv A
gM
FLRP
D-01
Mer
il Di
agno
stic
s Pr
ivat
e Lt
d.76
.025
.710
0.0
100.
02.
00.
74.
00.
01.
00.
06
No
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
52Bl
ue C
ross
Bio
-Med
ical (
Beiji
ng) C
o., L
td.
92.0
100.
010
0.0
100.
021
.553
.69.
034
.377
.10.
05
No
One
Step
Mal
aria
P.f/
P.v
Who
le B
lood
Tes
tjW
056-
CG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd.
78.0
0.0
99.0
74.3
0.0
(399
)0.
05.
50.
00.
00.
16
No
OnSi
te M
alar
ia P
f/Pv
Ag
Rapi
d Te
stj
R011
2CCT
K Bi
otec
h, In
c.74
.080
.098
.010
0.0
0.0
(399
)1.
40.
00.
00.
0 (2
07)
0.2
6N
oPa
raHI
T®fV
Rap
id te
st fo
r P. f
alcip
arum
and
P. v
ivax M
alar
ia -
Devi
ce55
IC40
2-50
ARKR
AY H
ealth
care
Pvt
. Ltd
.n63
.037
.191
.085
.72.
0 (3
99)
5.7
0.5
2.9
6.4
0.1
5N
oQu
ickP
rofil
e™ M
alar
ia P
f/Pv
Tes
t71
050
Lum
iqui
ck D
iagn
ostic
s, In
c.78
.025
.710
0.0
100.
04.
00.
04.
00.
00.
00.
16
No
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
Yes
Rapi
GEN
BIO
CRED
IT M
alar
ia A
g Pf
/Pv
(HRP
II/pL
DH)
C40R
HA2
5Ra
piG
EN In
c.92
.091
.410
0.0
100.
02.
5 (3
99)
0.0
1.0
2.9
4.4
(207
)0.
26
Yes
SD B
iolin
e M
alar
ia A
g P.
f/P.
vj05
FK80
Stan
dard
Dia
gnos
tics,
Inc.
92.0
94.3
100.
010
0.0
0.5
0.7
0.0
0.0
1.9
0.0
6Ye
sm
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
No
Tabl
e S2
: Mal
aria
RDT
pha
se-2
per
form
ance
in r
ound
s 3–
6 ag
ains
t w
ild-t
ype
(clin
ical
) sa
mpl
es c
onta
inin
g P.
falc
ipar
um (
Pf)
and
P. v
ivax
(Pv
) at
low
(200
)
and
high
(200
0 or
500
0) p
aras
ite
dens
ity
(par
asit
es/μ
L) a
nd c
lean
-neg
ativ
e sa
mpl
es (c
ontin
ued)
Sum
ma
ry
ro
un
dS
1-6
1514 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Prod
uct
Prod
uct
code
Man
ufac
ture
r
Pane
l det
ectio
n sc
orea
False
-pos
itive
rat
es (%
)To
tal f
alse
-pos
itive
ra
tesb
(%)
Inva
lid
rate
(%
)lRo
und
Mee
ts
WH
O
proc
urem
ent
crite
ria
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
False
-po
sitiv
e
non-
Pf
infe
ctio
ne
False
-po
sitiv
e
Pf
infe
ctio
nf
False
-po
sitiv
e
non-
Pf
infe
ctio
ng
False
-po
sitiv
e
Pf
infe
ctio
nh
False
-pos
itive
Pl
asm
odiu
m sp
p.
Infe
ctio
ni
Pf, P
f an
d Pv
SD B
iolin
e M
alar
ia A
g P.
f/P.
f/P.
v05
FK12
0St
anda
rd D
iagn
ostic
s, In
c.85
.091
.410
0.0
100.
00.
00.
00.
50.
00.
00.
06
Yes
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
3N
odi
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
3N
oPa
n on
lyAd
vant
age
Pan
Mal
aria
Car
dIR
0130
25J.
Mitr
a &
Co.
Pvt
. Ltd
.77
.010
0.0
98.0
100.
0N
AN
AN
AN
A0.
40.
05
Yes
AZOG
hCG
Mal
aria
Det
ectio
n Te
st D
evic
eM
PT-1
24AZ
OG, I
NC.
61.2
0.0
9955
.9N
AN
AN
AN
A2.
20.
24
No
Care
Star
t™ M
alar
ia p
LDH
(PAN
)G
0111
Acce
ss B
io, I
nc.
84.0
88.6
99.0
97.1
NA
NA
NA
NA
0.0
0.0
5Ye
sm
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
No
Para
bank
™ D
evic
e -
Rapi
d te
st fo
r Mal
aria
Pan
50
3010
25Ze
phyr
Bio
med
ical
Sys
tem
s17
.262
.990
.910
0.0
NA
NA
NA
NA
0.5
0.2
3N
o
NA,
not
app
licab
lePf
, Plas
mod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
Pvom
, Pla
smod
ium
viv
ax, o
vale
and
mal
aria
ea
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
8; R
ound
5, n
=100
; Ro
und
6, n
=100
d Ro
und
1, n
=20;
Rou
nd 2
, n=4
0; R
ound
3, n
=35;
Rou
nd 4
, n=3
4; R
ound
5, n
=35;
Ro
und
6, n
=35
e Fo
r com
bina
tion
test
s, pa
n or
Pv
line,
onl
y, po
sitiv
e in
dica
tes
a fa
lse
posi
tive
non
P. fa
lcip
arum
infe
ctio
n (R
ound
1 n
=316
; Rou
nd 2
, n=4
00; R
ound
3, n
=396
; Ro
und
4, n
=392
; Rou
nd 5
, n=4
00);
Roun
d 6,
n=4
00)
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;
Roun
d 2,
n=1
60; R
ound
3, n
=140
; Rou
nd 4
, n=1
36; R
ound
5, n
=140
; Rou
nd 6
, n=1
40)
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
; Rou
nd 3
, n=1
98;
Roun
d 4,
n=1
96; R
ound
5, n
=200
; Rou
nd 6
, n=2
00)
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=4
0;
Roun
d 2,
n=8
0, R
ound
3, n
=70;
Rou
nd 4
, n=6
8; R
ound
5, n
=70;
Rou
nd 6
, n=7
0)i
Roun
d 1,
n=1
68; R
ound
2, n
=200
; Rou
nd 3
, n=2
00; R
ound
4, n
=232
; Rou
nd 5
, n=2
36;
Roun
d 6,
n=2
08j
Prod
uct r
esub
mis
sion
, re
sults
from
mos
t rec
ent R
ound
of t
estin
g re
plac
e pr
evio
us
resu
lts. R
efer
to T
able
S1.
k
PDS
pres
ente
d in
the
tabl
e is
bas
ed o
n a
posi
tive
Pf te
st li
ne (e
ither
HRP
2 or
Pf-
pLDH
). Fo
r tes
t lin
e sp
ecifi
c re
sults
refe
r to
the
tabl
es a
nd a
nnex
es in
the
full
repo
rts.
l Ro
und
1, n
=954
; Rou
nd 2
, n=1
240;
Rou
nd 3
, n=1
204;
Rou
nd 4
, n=1
192;
Ro
und
5, n
=121
4 ; R
ound
6, n
=121
0m
Indi
cate
s a
WH
O pr
equa
lified
pro
duct
n
Span
Dia
gnos
tics
Ltd.
is n
ow A
RKRA
Y H
ealth
care
Pvt
. Ltd
.
Perf
orm
ance
mea
sure
Reco
mm
ende
d W
HO
pr
ocur
emen
t cr
iteria
Pa
nel d
etec
tion
scor
e fo
r Pf a
nd P
v 20
0/µL
sam
ples
≥ 75
%
Fals
e-po
sitiv
e ra
tes
agai
nst c
lean
-neg
ativ
es
< 10
%
Inva
lid ra
te<
5% o
f tes
ts c
ondu
cted
Tabl
e S2
(con
tinue
d)
1716 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Tabl
e S3
: Mal
aria
RDT
rou
nds
3–6
heat
sta
bilit
y re
sult
s on
a c
ultu
red
P. fa
lcip
arum
sam
ple
at lo
w (2
00)
and
high
(200
0) p
aras
ite
dens
ity
(par
asit
es/μ
L).
Posi
tivi
ty r
ate
at b
asel
ine
(roo
m t
empe
ratu
re)
and
afte
r 60
day
s’ in
cuba
tion
at 3
5 °C
and
45
°C
Prod
uct
Prod
uct
code
Man
ufac
ture
r
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(P
f lin
e)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(P
f lin
e)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(p
an li
ne)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(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
Pf T
esta
ITP11
002T
C1/TC
40In
Tec
Prod
ucts
, Inc
.93
.396
.790
.010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
5Ad
vant
age
P.f.
Mal
aria
Car
dIR
0160
25J.
Mitr
a &
Co.
Pvt
. Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A5
BION
OTE
MAL
ARIA
P.f.
Ag
Rapi
d Te
st K
itaRG
19-1
1Bi
onot
e,In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A6
Care
Star
t™ M
alar
ia H
RP2
(Pf)
G014
1m/G
0141
-ET
Acce
ss B
io, I
nc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
5Ca
reSt
art™
Mal
aria
HRP
2/pL
DH P
f tes
taG0
181m
/G01
81-E
TAc
cess
Bio
, Inc
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A6
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
3Ez
Dx™
Mal
aria
Pf R
apid
Mal
aria
ant
igen
det
ectio
n te
stRK
MAL
008
Advy
Che
mic
al P
rivat
e Li
mite
d10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A6
Firs
t Res
pons
e® M
alar
ia A
g P.
falc
ipar
um (H
RP2)
Car
d Te
stI1
3FRC
25Pr
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
5Fi
rst R
espo
nse®
Mal
aria
Ag
P. fa
lcip
arum
(HRP
2) C
ard
Test
PI13
FRC
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A6
Firs
tSig
n™ M
alar
ia P
f21
00CB
-25
Uni
med
Inte
rnat
iona
l Inc
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Hum
asis
Mal
aria
P.f
Antig
en T
est
ANM
PF-7
025
Hum
asis
Co.
, Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A6
ICT
Diag
nost
ics
Mal
aria
P.f.
ML0
1IC
T In
tern
atio
nal
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3IM
MU
NOQ
UIC
K® C
ONTA
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
UN
OQU
ICK®
MAL
ARIA
falc
ipar
um05
02_K
25Bi
osyn
ex10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A5
KHB®
Mal
aria
Ag
P.f R
apid
Tes
tKH
-R-0
6-20
Sh
angh
ai K
ehua
Bio
-eng
inee
ring
Co.,L
td.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
5M
alar
ia A
ntig
en T
est-
PfM
AG01
040
Osca
r Med
icar
e Pv
t. Lt
d.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A6
Mal
eris
can®
Mal
aria
P.f
Antig
en T
est
MAT
-PF-
50Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4N
anoS
ign
Mal
aria
Pf A
g RM
AF10
Biol
and,
Ltd
96.7
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
One
Step
Mal
aria
P.F
Tes
t (Ca
sset
te)
5223
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co.
, Ltd
.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
Who
le b
lood
Tes
taW
37-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
., Lt
d.10
0.0
93.3
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
6On
Site
Mal
aria
Pf A
g Ra
pid
Test
aR0
114C
CTK
Biot
ech,
Inc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
6Pa
rach
eck®
Pf-
Rapi
d Te
st fo
r P. f
alci
paru
m M
alar
ia D
evic
e (V
er.3
)30
2030
025
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)
3020
4002
5Or
chid
Bio
med
ical
Sys
tem
s 10
0.0
96.7
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4Pa
raH
IT®
- f V
er. 1
(Dev
ice)
55IC
104-
50AR
KRAY
Hea
lthca
re P
vt. L
td.c
100.
096
.710
0.0
100.
010
0.0
90.0
NA
NA
NA
NA
NA
NA
3Pa
raH
IT®
- f V
er. 1
(Dip
stic
k)55
IC10
3-50
ARKR
AY H
ealth
care
Pvt
. Ltd
.c10
0.0
100.
056
.710
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3Ra
pid
1-2-
3® H
ema®
Cas
sett
e M
alar
ia P
FMA
L-PF-C
AS/25
(100
)H
ema
Diag
nost
ic S
yste
ms
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
6Ra
piG
EN B
IOCR
EDIT
Mal
aria
Ag
Pf (H
RPII)
C10R
HA2
5Ra
piG
EN In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A6
Righ
tSig
n® M
alar
ia P
.f. R
apid
Tes
t Cas
sett
e (W
hole
Blo
od)
IMPF
-C51
Han
gzho
u Bi
otes
t Bio
tech
Co.
, Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A6
SD B
IOLI
NE
Mal
aria
Ag
P.f.
(HRP
2/pL
DH)a,
b05
FK90
Stan
dard
Dia
gnos
tics
Inc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
6SD
BIO
LIN
E M
alar
ia A
g Pf
05FK
50St
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
A5
Trus
ty™
Mal
aria
Ant
igen
P.f.
test
A03-
01-3
22Ar
tron
Lab
orat
orie
s In
c.10
0.0
100.
056
.710
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4Pf
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
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
0.0
0.0
0.0
4AC
CUCA
RE O
NE
STEP
MAL
ARIA
Pf/
Pan
Antig
en T
est
MAG
C 25
LAB-
CARE
Dia
gnos
tics (
Indi
a) P
VT. L
TD.
83.3
73.3
10.0
100.
010
0.0
100.
03.
310
.00.
070
.090
.030
.05
Adva
nced
Qua
lity™
Rap
id M
alar
ia T
est (
Pf/P
an)
ITP1
1005
InTe
c Pr
oduc
ts, I
nc.
86.7
96.7
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
70.0
100.
080
.05
Adva
ntag
e M
al C
ard
IR22
1025
J. M
itra
& C
o. P
vt. L
td.
0.0
0.0
0.0
100.
010
0.0
100.
00.
00.
00.
070
.010
0.0
80.0
5Ad
vant
age
Mal
aria
Pan
+ P
f Car
dIR
2310
25J.
Mitr
a &
Co.
Pvt
. Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
080
.093
.326
.710
0.0
100.
010
0.0
5AT
OMOR
APID
™ M
ALAR
IA (P
F/PA
N)
MM
AL01
Atom
o Di
agno
stic
s PT
Y Li
mite
d10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
016
.70.
010
0.0
100.
010
0.0
6AZ
OG M
alar
ia p
f (HR
PII)/
pf (L
DH)/
(PAN
-LDH
) Ant
igen
Det
ectio
n De
viceb
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
4BI
ONOT
E M
ALAR
IA P
.f.&
Pan
Ag
Rapi
d Te
st K
itaRG
19-0
8Bi
onot
e, In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
00.
010
0.0
100.
010
0.0
6
Sum
ma
ry
ro
un
dS
1-6
1716 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Prod
uct
Prod
uct
code
Man
ufac
ture
r
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(P
f lin
e)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(P
f lin
e)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(p
an li
ne)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(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
BioT
race
r™ M
alar
ia P
.f/PA
N R
apid
Car
da17
012
Bio
Focu
s Co
., Lt
d.10
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
93.3
66.7
100.
010
0.0
100.
06
Care
Star
t™ M
alar
ia/P
regn
ancy
Com
bo (p
LDH
/HRP
2/H
CG)
GO2
21Ac
cess
Bio
Inc
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
3Ca
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/PA
N) C
OMBO
G013
1m/G
0131
-ET
Acce
ss B
io, I
nc.
100.
010
0.0
96.7
100.
010
0.0
100.
093
.386
.753
.310
0.0
100.
010
0.0
5Ca
reSt
art™
Mal
aria
pLD
H 3
Lin
e Te
st
GO1
21Ac
cess
Bio
, Inc
.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
ia S
cree
n G
O231
Acce
ss B
io, I
nc.
100.
010
0.0
93.3
100.
010
0.0
100.
010
0.0
100.
093
.310
0.0
100.
010
0.0
3Co
re M
alar
ia P
an P
fM
AL-1
9002
4Co
re D
iagn
ostic
s Lt
d.10
0.0
100.
010
0.0
100.
010
0.0
100.
026
.780
.083
.310
0.0
100.
010
0.0
4di
agno
stic
ks M
ALAR
IA (P
an/P
f) Ca
sset
te
MPN
FWBC
1007
.4SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
s10
0.0
100.
096
.710
0.0
100.
010
0.0
0.0
0.0
0.0
100.
090
.090
.03
DIAQ
UIC
K M
alar
ia P
.f/Pa
n Ca
sset
teZ1
1200
CEDI
ALAB
Gm
bH10
0.0
100.
096
.710
0.0
100.
010
0.0
0.0
0.0
0.0
100.
010
0.0
80.0
5Ez
Dx™
Mal
aria
Pan
/Pf R
apid
test
det
ectio
n Ki
taRK
MAL
001
Advy
Che
mic
al P
rivat
e Li
mite
d10
0.0
100.
010
0.0
100.
010
0.0
100.
03.
323
.310
.010
0.0
100.
010
0.0
6Fi
rst R
espo
nse®
Mal
aria
Ag.
pLD
H/H
RP2
Com
bo C
ard
Test
I16F
RCPr
emie
r Med
ical
Cor
pora
tion
Ltd.
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
10.0
0.0
100.
010
0.0
100.
05
Firs
t Res
pons
e® M
alar
ia A
g. p
LDH
/HRP
2 Co
mbo
Car
d Te
stPI
16FR
CPr
emie
r Med
ical
Cor
pora
tion
Ltd.
100.
010
0.0
100.
010
0.0
100.
010
0.0
96.7
100.
070
.010
0.0
100.
010
0.0
6Fi
rstS
ign™
Par
aVie
w (P
an+P
f)21
01CB
-25
Uni
med
Inte
rnat
iona
l Inc
.96
.710
0.0
100.
010
0.0
100.
010
0.0
0.0
0.0
13.3
100.
010
0.0
100.
04
Gen
Body
™M
alar
ia P
f/Pa
n Ag
MAL
AG10
0G
enBo
dy In
c.10
0.0
100.
093
.310
0.0
100.
010
0.0
0.0
0.0
0.0
50.0
100.
010
.05
Gen
edia
® M
alar
ia P
.f/Pa
n Ag
Rap
id T
est
20-0
146-
01Gr
een
Cros
s Med
ical S
cienc
e Cor
p. (K
orea
)10
0.0
100.
043
.310
0.0
100.
010
0.0
3.3
0.0
13.3
0.0
0.0
0.0
5H
umas
is M
alar
ia P
.f/Pa
n An
tigen
Tes
taAM
AL-7
025
Hum
asis,
Co.
, Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
00.
010
0.0
100.
010
0.0
5H
umas
is M
alar
ia P
.f/Pa
n An
tigen
Tes
tAN
MAL
-702
5H
umas
is, C
o., L
td.
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
100.
010
0.0
100.
06
ICT
Mal
aria
Dua
l Tes
tM
L03
ICT
Inte
rnat
iona
l10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
00.
090
.090
.090
.05
IMM
UN
OQU
ICK
CON
TACT
MAL
ARIA
+4
0525
K25
Bios
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
Is It
… M
alar
ia P
f/Pv
Dev
ice
AL03
0M
edso
urce
Ozo
ne B
iom
edic
als
100.
010
0.0
96.7
100.
010
0.0
100.
093
.196
.636
.710
0.0
100.
090
.06
Mal
aria
Pan
Tes
t M
AL-W
23N
-001
Dim
a •
Gese
llsch
aft f
ür D
iagn
ostik
a m
bH60
.033
.323
.310
0.0
100.
090
.013
.353
.340
.010
.060
.040
.03
Mal
aria
Pf./
Pan
Antig
en (M
AL P
f/Pa
n) T
est K
itA0
3-18
-322
Artr
on L
abor
ator
ies
Inc.
10.0
6.7
0.0
100.
010
0.0
100.
010
.03.
30.
010
0.0
100.
090
.05
Mal
aria
pf (
HRP
II) /
(PAN
-pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
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
4M
alar
ia p
f (pL
DH) /
PAN
-pLD
H T
est D
evic
eM
FV-1
24AZ
OG, I
nc.
46.7
56.7
66.7
100.
010
0.0
100.
013
.393
.310
0.0
60.0
100.
010
0.0
5M
alar
ia P
f/ P
ANG
M00
4Ge
nom
ix M
olec
ular
Dia
gnos
tics P
vt.Lt
d.56
.723
.326
.710
0.0
100.
010
0.0
0.0
0.0
0.0
60.0
90.0
50.0
4M
alar
ia P
f/Pa
n On
e St
ep R
apid
Tes
tRT
202
22Zh
ejia
ng O
rient
Gen
e Bi
otec
h Co
., Ltd
.10
0.0
100.
096
.710
0.0
90.0
100.
00.
00.
00.
010
0.0
90.0
100.
05
Mal
asca
n™ D
evic
e -
Rapi
d te
st fo
r Mal
aria
Pf/
Pan
5040
2025
Zeph
yr B
iom
edic
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
MeD
iPro
Mal
aria
Ag
HRP
2/pL
DH C
ombo
IR-0
051K
Form
osa
Biom
edic
al Te
chno
logy
Cor
p.10
0.0
96.7
96.7
100.
010
0.0
100.
00.
00.
00.
00.
00.
00.
04
Mer
iscr
een
Mal
aria
Pf/
Pan
Ag
MH
LRPD
-01
Mer
il Di
agno
stic
s Pr
ivat
e Lt
d.10
0.0
100.
010
0.0
100.
010
0.0
100.
046
.756
.70.
010
0.0
100.
010
0.0
6N
anoS
ign
Mal
aria
pf/
pan
Ag 3
.0RM
AP10
Biol
and
Ltd.
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
100.
010
0.0
100.
04
Nan
oSig
n M
alar
ia P
f/Pv
Ag
RMAD
10Bi
olan
d, L
td0.
00.
00.
020
.00.
00.
00.
00.
00.
00.
00.
00.
03
NG
-Tes
t MAL
ARIA
Pf/
Pan
(pLD
H)
NG-M
AL-W
23-0
01SA
RL N
G B
iote
ch, Z
.A.
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
6.7
0.0
100.
010
0.0
100.
05
One
Step
Mal
aria
P.f/
Pan
Test
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
e St
ep M
alar
ia P
.f/Pa
n W
hole
Blo
od T
est
W62
-CG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd.
100.
010
0.0
96.7
100.
010
0.0
100.
00.
00.
00.
090
.010
0.0
70.0
6On
Site
Mal
aria
Pf/
Pan
Ag R
apid
Tes
taR0
113C
CTK
Biot
ech,
Inc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
6.7
0.0
100.
010
0.0
100.
06
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
scre
en®
- Ra
pid
test
for M
alar
ia P
an/P
fa50
3030
025
Zeph
yr B
iom
edic
als
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
090
.093
.310
0.0
100.
010
0.0
6Qu
ickP
rofil
e™ M
alar
ia P
f/Pa
n Te
st71
063
Lum
iqui
ck D
iagn
ostic
s, In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
96.7
100.
010
0.0
100.
010
0.0
6Ra
piG
EN B
IOCR
EDIT
Mal
aria
Ag
Pf/P
an (H
RPII/
pLDH
)aC3
0RH
A25
Rapi
GEN
Inc.
100.
010
0.0
96.7
100.
010
0.0
100.
00.
010
.026
.710
0.0
100.
010
0.0
6Ri
ghtS
ign™
Mal
aria
P.f.
/Pan
Rap
id T
est C
asse
tte
IMPN
-C52
Han
gzho
u Bi
otes
t Bio
tech
Co.
Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
020
.010
0.0
100.
060
.010
0.0
5
Tabl
e S3
(con
tinue
d)
(con
tinue
d)
1918 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Prod
uct
Prod
uct
code
Man
ufac
ture
r
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(P
f lin
e)
P erc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(P
f lin
e)
P erc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(p
an li
ne)
P erc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(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/
Pan
05FK
60St
anda
rd D
iagn
ostic
s In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
00.
010
0.0
100.
010
0.0
5SD
BIO
LIN
E M
alar
ia A
g Pf
/ Pan
05FK
66St
anda
rd D
iagn
ostic
s In
c.
96.7
96.7
100.
090
.010
0.0
100.
016
.610
.00.
090
.010
0.0
100.
04
SD B
IOLI
NE
Mal
aria
Ag
05FK
40St
anda
rd D
iagn
ostic
s In
c.0.
00.
00.
010
0.0
80.0
90.0
0.0
0.0
0.0
80.0
20.0
90.0
3Vi
kia®
Mal
aria
Ag
Pf/P
an41
2499
IMAC
CESS
S.A
.S10
0.0
96.7
96.7
100.
010
0.0
100.
00.
00.
00.
060
.060
.00.
05
Pf a
nd P
v/Pv
omAd
vanc
ed Q
ualit
y™ O
ne St
ep M
alar
ia (P
f/Pv)
Tri-L
ine T
est (
who
le bl
ood)
a 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
A6
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
3AS
AN E
asy
Test
® M
alar
ia P
f/Pa
n Ag
AM46
50-K
ASAN
Pha
rmac
eutic
al C
o., L
td
100.
096
.763
.310
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
5BI
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
3Bi
oTra
cer™
Mal
aria
P.f/
P.v
Rapi
d Ca
rd17
412
Bio
Focu
s Co
., Lt
d.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A6
Care
Star
t Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOG0
161m
/G01
61-E
TAc
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 Mal
aria
HRP
2/pL
DH (P
f/VO
M) C
OMBO
G017
1/G0
171-
ETAc
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
3Co
rete
sts®
One
Ste
p M
alar
ia P
f/Pv
Ag
Test
Dev
ice
B42-
21/B
42-2
2Co
re T
echn
olog
y Co
., Lt
d.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A6
EzDx
™ M
alar
ia P
v/Pf
Rap
id M
alar
ia a
ntig
en d
etec
tion
test
RK M
AL 0
03Ad
vy C
hem
ical
Priv
ate
Lim
ited
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
6Fa
lciV
ax™
- R
apid
Tes
t for
Mal
aria
Pv/
Pfa
5030
1002
5Ze
phyr
Bio
med
ical
s10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A6
Firs
t Res
pons
e® M
alar
ia A
g Pf
/Pv
Card
Tes
tPI
19FR
CPr
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
6H
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
Hum
asis
Mal
aria
P.f/
P.v
Antig
en T
est
ANM
IV-7
025
Hum
asis,
Co.
, Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A6
KHB®
Mal
aria
Ag
P.f/
P.v
Rapi
d Te
stKH
-R-0
7-50
Shan
ghai
Keh
ua B
io-e
ngin
eerin
g Co
., Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A6
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 (
HRP
II)/ P
V (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e G
M00
6Ge
nom
ix M
olec
ular
Dia
gnos
tics P
vt. L
td.
83.3
90.0
83.3
100.
090
.070
.0N
AN
AN
AN
AN
AN
A5
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
alar
ia P
V/PF
(pLD
H/H
RP2)
Ant
igen
Tes
t In
f-72
Nan
tong
Ege
ns B
iote
chno
logy
Co.
, Ltd
.10
0.0
100.
096
.610
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
6M
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
(P) L
td.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
5M
eris
cree
n M
alar
ia P
f/Pv
Ag
MFL
RPD-
01M
eril
Diag
nost
ics
Priv
ate
Ltd.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
6On
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.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
5On
e St
ep M
alar
ia P
.f/P.
v W
hole
Blo
od T
esta
W05
6-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
., Lt
d.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A6
OnSi
te M
alar
ia P
f/Pv
Ag
Rapi
d Te
sta
R011
2CCT
K Bi
otec
h, In
c.10
0.0
100.
090
.010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
6Pa
raHI
T®fV
Rap
id te
st fo
r P. f
alcip
arum
and
P. v
ivax
Mal
aria
- De
vice
55IC
402-
50Sp
an D
iagn
ostic
s Lt
d.10
0.0
96.7
96.7
100.
010
0.0
90.0
NA
NA
NA
NA
NA
NA
5Qu
ickP
rofil
e™ M
alar
ia P
f/Pv
Tes
t71
050
Lum
iqui
ck D
iagn
ostic
s, In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A6
RAPI
D 1-
2-3®
HEM
A CA
SSET
TE M
ALAR
IA P
F/PV
TES
TMA
L-PFV
-CAS
/25(10
0)H
ema
Diag
nost
ic S
yste
ms,
LLC
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4Ra
piG
EN B
IOCR
EDIT
Mal
aria
Ag
Pf/P
v (H
RPII/
pLDH
)C4
0RH
A25
Rapi
GEN
Inc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
6SD
Bio
line
Mal
aria
Ag
P.f/
P.va
05FK
80St
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
A6
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
4Pf
, Pf
and
PvSD
Bio
line
Mal
aria
Ag
P.f/
P.f/
P.vb
05FK
120
Stan
dard
Dia
gnos
tics,
Inc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
6Pf
, Pv
and
pan
Core
™ M
alar
ia P
an/P
v/Pf
M
AL-1
9002
6Co
re D
iagn
ostic
s10
0.0
100.
010
0.0
100.
090
.010
0.0
0.0
0.0
0.0
80.0
50.0
70.0
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
96.7
100.
093
.310
0.0
100.
010
0.0
0.0
0.0
0.0
70.0
0.0
50.0
3
Tabl
e S3
: Mal
aria
RDT
rou
nds
3–6
heat
sta
bilit
y re
sult
s on
a c
ultu
red
P. fa
lcip
arum
sam
ple
at lo
w (2
00)
and
high
(200
0) p
aras
ite
dens
ity
(par
asit
es/μ
L).
Posi
tivi
ty r
ate
at b
asel
ine
(roo
m t
empe
ratu
re)
and
afte
r 60
day
s’ in
cuba
tion
at 3
5 °C
and
45
°C (c
ontin
ued)
Sum
ma
ry
ro
un
dS
1-6
1918 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Prod
uct
Prod
uct
code
Man
ufac
ture
r
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(P
f lin
e)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(P
f lin
e)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(p
an li
ne)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(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
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
IR01
3025
J. M
itra
& C
o. P
vt. L
td.
NA
NA
NA
NA
NA
NA
36.7
66.7
60.0
100.
010
0.0
90.0
5AZ
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
100.
010
0.0
100.
010
0.0
5di
agno
stic
ks M
ALAR
IA (P
an) C
asse
tte
MPN
WBC
1007
.3SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
sN
AN
AN
AN
AN
AN
A0.
00.
00.
080
.010
0.0
80.0
3Pa
raba
nk™
Dev
ice
- Ra
pid
test
for M
alar
ia P
an50
3010
25Ze
phyr
Bio
med
ical
Sys
tem
sN
AN
AN
AN
AN
AN
A0.
00.
00.
090
.010
0.0
100.
03
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
Pvo
m, P
lasm
odiu
m v
ivax
, ova
le a
nd m
alar
iae
Indi
cate
s re
sults
for t
hose
pro
duct
s th
at m
eet a
ll W
HO
reco
mm
ende
d pr
ocur
emen
t crit
eria
a 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
S1.
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:
c S
pan
Diag
nost
ics
Ltd.
is n
ow A
RKRA
Y H
ealth
care
Pvt
. Ltd
.
Prod
uct
Prod
uct
co
deM
anuf
actu
rer
Perc
enta
ge p
ositi
ve t
est
resu
lts
for
P. f
alci
paru
m (P
f lin
e)Pe
rcen
tage
pos
itive
tes
t re
sults
fo
r P.
fal
cipa
rum
(Pf l
ine)
Perc
enta
ge p
ositi
ve t
est
resu
lts
for
P. f
alci
paru
m (p
an li
ne)
Perc
enta
ge p
ositi
ve t
est
resu
lts
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/
µLBa
selin
e35
°C45
°CBa
selin
e35
°C45
°CBa
selin
e35
°C45
°CBa
selin
e35
°C45
°CN
umbe
r of
tes
ts p
ositi
veN
umbe
r of
tes
ts p
ositi
veN
umbe
r of
tes
ts p
ositi
veN
umbe
r of
tes
ts p
ositi
veLo
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
dSD
Bio
line
Mal
aria
Ag
P.f/
P.f/
P.v
- (P
F(H
RP2)
line
)05
FK12
0St
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
A6
SD B
iolin
e M
alar
ia A
g P.
f/P.
f/P.
v -
(PF(
pLDH
) lin
e)05
FK12
0St
anda
rd D
iagn
ostic
s, In
c.30
.030
.030
.010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
6SD
BIO
LIN
E M
alar
ia A
g P.
f. (H
RP2/
pLDH
) - (P
F(H
RP2)
line
)05
FK90
Stan
dard
Dia
gnos
tics,
Inc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
6SD
BIO
LIN
E M
alar
ia A
g P.
f. (H
RP2/
pLDH
)- (P
F(pL
DH) l
ine)
05
FK90
Stan
dard
Dia
gnos
tics,
Inc.
93.3
90.0
66.7
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A6
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
Tabl
e S3
(con
tinue
d)
2120 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Table S4: Products evaluated during rounds 1-6 that have been removed from summary results listings
Manufacturer Product Product code
Amgenix International, Inc.
OnSight™ - Malaria Pf Test 511-25-DBOnSight™ - ParaQuick-2 (Pv,Pf) Malaria Test 537-25-DBOnSight™ - PanScreen (Pan) Malaria Test 539-25-DBOnSight™ - ParaQuick (Pan, Pf) Test 536-25-DB
Abon Biopharm (Hangzhou) Co. Ltd. (Iverness Medical) ABON Malaria Pan/P.f.Rapid Test Device (whole blood) IMA-B402
Access Bio EthiopiaParaCare Malaria HRP2/pLDH (Pf/Pv) COMBO G0161ParaCare Malaria HRP2/pLDH (Pf/VOM) COMBO G0171
ACON Biotech (Hangzhou) Co. Ltd Surestep™ Malaria Pf/Pan Rapid Test Device (Whole Blood) IMA-T402
Acon Laboratories, Inc Malaria Plasmodium falciparum Rapid Test Device (Whole Blood) IMA-402
Bhat Bio-Tech India (P) Ltd Maleriscan® Malaria Pf/Pv MAT-50Biosynex Immunoquick Malaria +4 0506_K25Diagnostics Automation/Cortez Diagnostics Inc. Malaria P.F/Vivax 172110P-25
HBI Co., Ltd.HiSens Malaria Ag P.f/P.v Card HR2823HiSens Malaria Ag Pf/Pv (HRP2/pLDH) Card HR2923HiSens Malaria Ag Pf HRP2 Card HR3023
Human GmbHHexagon Malaria 58051Hexagon Malaria Combi 58024
ICT INTERNATIONALICT Malaria Combo ML02ICT MALARIA P.F. ML04
IND Diagnostic Inc.One Step Malaria Antigen Strip 820-1IND ONE STEP MALARIA ANTIGEN P.f/Pan TEST 535-10IND ONE STEP MALARIA ANTIGEN P.f 535-11
Innovatek Medical Inc. Quickstick Malaria Antigen TestInverness Medical Innovations, Inc. Binax Now Malaria IN660050Medical Diagnostech (Pty) Ltd MD Malaria Pf/Pan (pLDH) test MDMALLDH001
Medisensor, Inc.Medisensor Malaria HRP2/pLDH (Pf/Pv) COMBO M161Medisensor Malaria HRP2/pLDH (Pf/VOM) COMBO M171
Orgenics Ltd. (Inverness Innovations) Clearview® Malaria pLDH 70884025Orgenics Ltd.(IS) Clearview® Malaria Dual VB20Premier Medical Corporation Ltd. First Response® Malaria Ag pLDH I12FRC30RapiGen inc. BIOCREDIT Malaria pf(HRP II) HR0100
Span Diagnostics
ParaHIT®-f Dipstick 55IC101-50/25977ParaHIT®- f Device 55IC102-50/25975ParaHIT - Total (Device) 55IC202-10/25989ParaHIT Pan M (dipstick) 55IC301-10ParaHIT total (dipstick) 55IC201-10/25988
SSA Diagnostics & Biotech Systemsdiagnosticks- Malaria (Pf) Cassette KMFC6001diagnosticks- Malaria (Pf) Dipstick KMFD6007diagnosticks- Malaria (Pv/Pf) Cassette KMVFC6002
Standard Diagnostics Inc.
SD BIOLINE Malaria Ag Pf/ Pf/ Pv 05FK100SD BIOLINE Malaria Ag Pv 05FK70SD BIOLINE Malaria Ag P.f/Pan 05FK63a
SD Bioline Malaria Ag P.f/P.v 05FK83b
SD BIOLINE Malaria Ag Pf 05FK53c
Unimed International
FirstSign – Malaria Pf Card Test -FirstSign – ParaView-2 (Pv + Pf) Card Test 2102CB-25FirstSign™ - PanCheck (Pan) Malaria Test 2104 CB-25FirstSign™ - ParaView-3 (Pan+Pv+Pf) Malaria Test 2103 CB-25
Vision Biotech (Pty) LtdVision Malaria Pf VB01Clearview® Malaria Combo VB11
Zephyr Biomedicals Paramax-3 Rapid Test for Malaria Pan/Pv/Pf (device) 50320025
Pf, P. falciparum Pv, P. vivax Pvom, P. vivax, ovale, malariae HRP2, histidine-rich protein 2 pLDH, Plasmodium lactate dehydrogenase
a Previously co-listed with 05FK60 (multi-use pack), but removed because single pack format (05FK63) not evaluated at CDC b Previously co-listed with 05FK80 (multi-use pack), but removed because single pack format (05FK83) not evaluated at CDCc Previously co-listed with 05FK50 (multi-use pack), but removed because single pack format (05FK53) not evaluated at CDC
Sum
ma
ry
ro
un
dS
1-6
2120 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
2. references
1. World malaria report 2015. Geneva: World Health Organization; 2015.
2. Guidelines for the treatment of malaria. 2nd edition. Geneva: World Health Organization; 2010.
3. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 1 (2008). Geneva: World Health Organization; 2009.
4. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 2 (2009). Geneva: World Health Organization; 2010.
5. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 3 (2010–11). Geneva: World Health Organization; 2011.
6. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 4 (2012). Geneva: World Health Organization; 2012.
7. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 5 (2013). Geneva: World Health Organization; 2014.
8. Informal consultation on laboratory methods for quality assurance of malaria rapid diagnostic tests. Manila: WHO Regional Office for the Western Pacific; 2004 (RS/2004/GE/26(PHL).
9. Prequalification of in vitro diagnostics. Geneva: World Health Organization (http://www.who.int/
diagnostics_laboratory/evaluations/en/, accessed 13 October 2015).
10. Parasitological confirmation of malaria diagnosis. Report of a WHO technical consultation. Geneva, 6–8 October 2009. Geneva: World Health Organization; 2010.
11. Gamboa D, Ho MF, Bendezu J, et al. 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.
12. Kumar N, Pande V, Bhatt RM, Shah NK, Mishra N, Srivastava B, et al. Genetic deletion of HRP2 and HRP3 in Indian Plasmodium falciparum population and false negative malaria rapid diagnostic test. Acta Trop 2013;125(1):119-121.
13. Malaria RDT interactive guide. Geneva: Foundation for Innovative New Diagnostics (http://www.find-diagnostics.org/programs/malaria-afs/malaria/current-projects/rdt_quality_control/interactiveguide-intro/, accessed 13 October 2015).
14. Good practices for selecting and procuring rapid diagnostic tests for malaria. Geneva: World Health Organization; 2011.
15. Universal access to malaria diagnostic testing: an oper-ational manual. Geneva: World Health Organization; 2011.
2322 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
An
ne
xes
2322 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Annexes
2524 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Annex s1: characteristics of evaluation panels used in rounds 1–6 of wHo malaria rdt product testing, 2008–2015Currently, the basis for diagnosing malaria with antigen-detecting RDTs is the detection in a patient’s blood of one or more target malaria antigens, including HRP2 (P. falci-parum only), pLDH (Plasmodium spp.pan-pLDH), P. falciparum (Pf-pLDH), non-falciparum (Pv-pLDH, Pvom-pLDH) and aldolase (all Plasmodium spp). The antigen concentration in samples with the same parasite density varies. Therefore, the concentrations of malaria antigens in the samples that comprise evaluation panels must be consistent in successive rounds of WHO malaria RDT product testing to ensure that the results of each round are highly comparable (statistically equivalent).
Therefore, antigen concentrations were quantified in triplicate in all panel samples, including dilution pairs of 200 and 2000 parasites/µL, by quantitative ELISA. Only results that were consistent in the triplicate runs and showed a value factor between the 200 and the 2000 parasites/µL dilutions close to 10 were considered acceptable and eligible for the performance evaluation panel. In some instances, the antigen concentration was below the detection limit of the ELISA, particularly for aldolase, which is present in malaria parasite samples at much lower concentrations than the other two antigens. Samples that gave inconsistent results for more than one of the three antigens were excluded from the panel.
Despite careful standardization of procedures, the tables and figures below show a wide variation in antigen concentra-tions for the same parasite density. There are a number of possible explanations, including differences in the level of antigen expression by isolates; different durations of infection (accumulating antigens); different parasite growth stages at the time of collection (expressing different levels of antigen); the presence of circulating HRP2 from previous growth cycles; and HRP2 produced by parasites sequestered in the host’s vascular tissues that cannot be accounted for in the estimate of parasite density on the blood slide.
Before each round of WHO malaria RDT product testing, the distribution of HRP2, pLDH and aldolase concentrations at 200 parasites/µL dilution of the wild-type P. falciparum and wild-type P. vivax samples selected for the phase-2 panels were systematically compared with those in the previous round to ensure there was no statistically significant differ-ence. The figures and tables below show the distribution of antigen concentrations in all six performance evaluation panels. No statistically significant differences were seen (Kruskal-Wallis test; p > 0.5), confirming that the results of each new round are additive (and comparable) to the previous ones. In the following box and whisker plots, the end of whiskers represent minimum and maximum values; the box represents middle 50% of data and the line through box represents median values; the crosses represent the mean values.
Figure AS1.1: Box-and-whisker plot of distribution of P. falciparum HRP2 concentration (ng/mL) in product testing phase 2 (wildtype) panels.
10.5 2 4 8 16 32 64 128
P. falciparum HRP2 concentration (ng/ml)
Round 6
Round 5
Round 4
Round 3
Round 2
Round 1
Figure AS1.3: Box-and-whisker plot of distribution of P. vivax pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels.
Round 6
Round 5
Round 4
Round 3
Round 2
Round 1
1 2 4 8 16 32 64
P. vivax pLDH concentration (ng/ml)
Figure AS1.2: Box-and-whisker plot of distribution of P. falciparum pLDH concentration (ng/mL) in product testing phase 2 (wildtype) panels.
Round 6
Round 5
Round 4
Round 3
Round 2
Round 1
0.5
0.25
0.12
5 1 2 4 8 16 32 64
P. falciparum pLDH concentration (ng/ml)
Figure AS1.4: Box-and-whisker plot of distribution of P. falciparum aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels.
0.062
50.2
5
0.015
625 1 4 16
P. falciparum aldolase concentration (ng/ml)
Round 6
Round 5
Round 4
Round 3
Round 2
Round 1
An
ne
xes
2524 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Figure AS1.5: Box-and-whisker plot of distribution of P. vivax aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels.
1 2 4 8 16P. vivax aldolase concentration (ng/ml)
Round 6
Round 5
Round 4
Round 3
Round 2
Round 1
Table AS1.1: Statistics for P. falciparum HRP2 concentration (ng/mL) in product testing phase 2 (wild-type) panels.
Round 1 Round 2 Round 3 Round 4 Round 5 Round 6
Number of valuesa 78 99 99 98 99 99
Minimum 0.80 0.62 0.62 0.62 0.59 0.67
25th percentile 2.90 1.90 2.10 2.97 2.15 2.48
Median 9.57 6.76 6.83 6.98 6.76 8.12
75th percentile 18.94 16.91 17.37 15.65 15.31 15.51
Maximum 73.70 73.70 66.70 62.48 62.48 62.48
Mean 15.28 12.70 12.77 12.72 11.65 12.15
Std. Deviation 16.98 15.75 15.19 14.72 13.25 13.29a The number of values is the number of samples for which consistent ELISA results were obtained.
Table AS1.2: Statistics for P. falciparum pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels.
Round 1 Round 2 Round 3 Round 4 Round 5 Round 6
Number of valuesa 74 93 92 92 94 98
Minimum 0.71 0.19 0.19 0.19 0.19 0.19
25th percentile 6.68 6.27 6.23 6.20 6.90 7.04
Median 11.95 10.31 11.18 10.92 12.24 11.85
75th percentile 23.75 20.10 22.70 21.28 23.05 20.36
Maximum 47.15 47.15 47.15 53.53 43.02 53.53
Mean 15.31 13.71 15.08 14.97 15.53 15.61
Std. Deviation 11.47 10.90 11.72 11.98 11.43 12.00a The number of values is the number of samples for which consistent ELISA results were obtained.
Table AS1.3: Statistics for P. vivax pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels.
Round 1 Round 2 Round 3 Round 4 Round 5 Round 6
Number of valuesa 20 37 33 32 34 34
Minimum 5.10 1.64 1.64 1.64 1.64 1.64
25th percentile 8.10 8.40 7.30 6.96 6.26 6.72
Median 12.65 17.00 19.78 17.50 13.22 15.17
75th percentile 27.40 29.69 31.89 29.84 23.42 23.14
Maximum 44.40 47.90 47.90 47.90 47.90 44.79
Mean 17.38 20.24 20.99 20.00 16.84 16.90
Std. Deviation 11.57 13.27 13.55 13.00 12.59 11.78a The number of values is the number of samples for which consistent ELISA results were obtained.
2726 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Table AS1.4: Statistics for P. falciparum aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels.
Round 1 Round 2 Round 3 Round 4 Round 5 Round 6
Number of valuesa 77 98 99 97 98 99
Minimum 0.00 0.00 0.00 0.00 0.00 0.00
25th percentile 0.84 0.74 0.67 0.64 0.52 0.44
Median 1.58 1.49 1.40 1.25 1.17 1.18
75th percentile 2.25 2.25 2.23 2.25 2.07 2.02
Maximum 9.90 9.90 9.90 9.08 7.74 9.08
Mean 1.93 1.79 1.76 1.72 1.52 1.50
Std. Deviation 1.73 1.66 1.69 1.68 1.52 1.61a The number of values is the number of samples for which consistent ELISA results were obtained.
Table AS1.5: Statistics for P. vivax aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels.
Round 1 Round 2 Round 3 Round 4 Round 5 Round 6
Number of valuesa 20 40 34 33 35 35
Minimum 3.21 1.70 1.70 1.70 3.21 1.70
25th percentile 4.02 4.11 4.07 4.41 5.55 4.94
Median 6.33 6.15 6.10 6.16 6.86 6.54
75th percentile 8.47 8.47 8.32 9.10 9.43 9.68
Maximum 13.15 13.40 13.30 15.00 15.00 15.08
Mean 6.73 6.81 6.45 6.86 7.78 7.74
Std. Deviation 2.89 3.15 2.90 3.23 3.30 3.69a The number of values is the number of samples for which consistent ELISA results were obtained.
An
ne
xes
2726 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Annex s2: malaria rdt field assessment and anomaliesThe purpose of this assessment, on a limited number of RDTs, is to assess aspects of packaging, safety and ease-of-use and not to evaluate diagnostic accuracy.
Obtain samples of each malaria RDT under consideration (at least one box packaged as intended for delivery to end users).
Obtain malaria parasite-negative blood samples, and where readily accessible, parasite-positive blood samples for testing against RDTs.
Table AS2.1: Field assessment of RDT packaging, safety and ease-of-use to guide product selection
Date of assessment Commercial name Product code Lot number(s)
Yes No NA Problems /CommentsPackaging and accessories
The RDT box is in good conditionRDTs are in individual sealed package
The correctly indicated number of RDTs are in the boxDesiccant is included in each individual RDT package
An expiry date is visible on each RDT packageAll required accessories are included in the correct quantities
(RDT, buffer, blood transfer device, alcohol swab, lancet, gloves, test tubes (for dipsticks, only)
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 figures displaying
all possible interpretations of the RDT resultsThe text and figures are accurate and consistent
(specifically order of test lines and results interpretation)Preparation and procedure
The test package is easy to openIt is easy to write on the test device
The test lines on the device are clearly labelledIt is easy to use the device for blood collection
It is easy to open the buffer bottle or vialThe buffer bottle or vial have sufficient volume
for testing all RDTs in the boxThe buffer bottle or vial 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 and sample flow well along 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 min
Two or fewer timed steps Was one or more of the last 10 tests
you performed invalid (no control line)?If YES, how many?
SafetyAre there mixing wells (risk of blood splash)?
Retractable needle for finger prick?Is the RDT in a cassette format (unexposed strip)?
Have waste disposal safety concerns been addressed? (If no, please describe)
NA, not applicable
2928 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Figure AS2.1 illustrates examples of RDT observations/anomalies encountered and routinely recorded during round 6 of WHO Malaria RDT Product Testing at the CDC. In most cases, these anomalies do not invalidate the results, as reactivity in the control and test line areas are still visible, but they may pose challenges to health workers interpreting the results. Furthermore, they should be reported to manufacturers.
An expanded list of notable observations concerning RDT packaging, kit accessories (buffer vials, desiccants) and instruc-tions for use, is under development for use in both product testing and lot testing activities of the WHO-FIND Malaria RDT Evaluation Programme.
Figure AS2.1: Malaria RDT anomalies encountered in production lots
a) Observations on the test strip
Red background Background staining is relatively common. In this example, the result is positive as test lines are positive; however, a more intense red background may obscure weak positive test lines, giving false-negative results.
Incomplete clearing In this example, the result is positive as the test line is visible. Poor clearing of blood may obscure weak positive test lines, giving false-negative results.
b) Observations of flow problems
Failed migration Blood and buffer did not run the length of the strip
Incomplete migration One portion of the nitrocellulose near the test band was not absorptive and remained dry during wicking, creating irregular migra-tion of blood/buffer with red background. In this example, the result is positive, as the test line is clearly visible.
c) Observations on test lines
Ghost test lines White lines on a stained background. In this example, the result is negative, as the test line is not dark and is thus not visible.
Patchy broken test line(s)
The test line is visible but interrupted (broken).
Diffuse test line(s) Test line wider than control, without clearly defined edge.
C T1 T2
C T
C T
C T1
C T1 T2 T3
C T1 T2
C T
An
ne
xes
2928 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
d) RDT structural problems
Strip misplaced in the cassette (shift)
Strip can be seen only partially in the results window.
Specimen pad not seen in sample window
Normally, the colour of the conjugated antibody can be seen in the sample window (commonly purple, pink or blue).
Buffer remains pooled in the buffer well
The buffer is not completely absorbed and this may result in failed migration or incomplete clearing.
C T1 T2
3130 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Figure AS3.1: How to select of an appropriate RDT
Step 1.1Define setting of use
What? target parasite species and antigena
Pf-only or mixed Pf/non-Pf infections:- HRP2- pLDH-Pf; pLDH-pan
Pf and non-Pf infections (single species)b:- 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-Pvom
P. vivax, only:- aldolase- pLDH-pan- pLDH-Pv
**Pf without HRP2 – Do not use HRP2-based RDTsc
Where? Exposure to high temperature e.g. tropical environment ORtemperature-controlled environment, including during transport and storage
Who? Laboratory personnel ORhealth workers outside laboratories
Step 1.2Review RDT performance
WHO RDT product testing resultsd and apply WHO recommended RDT selection criteriae
- Panel detection score - False-positivity rate - Invalid rate - Ease-of-use- Thermal stability
Sensitivity and specificity based on high-quality field studies in relevant populations
Generate short-list of RDTs
Step 1.3Apply national guidelines and experience in use of RDTs
National malaria treatment guidelines
In-country experience, ease-of-use assessments (Annex S2), availability of training materials
Step 1.4Other considerations
- Price- Manufacturer: production capacity, lead times, heat stability data and storage conditions- Delivery schedules (e.g. staggered deliveries), box size, shelf life- Registration requirements of national regulatory authorities- Product lot testing results- Overall budget requirements (Annex 5)
a Pf-only or mixed Pf/non-Pf infections: Most areas of sub-Saharan Africa and lowland Papua New Guinea; Pf and non-Pf infections (single species): Most endemic areas of Asia and the Americas and isolated areas of the Horn of Africa; Mainly P. vivax-only: areas of East Asia, central Asia, South America, and some highland areas elsewhere
b Tests with a P. falciparum-specific line and pan-specific line will not distinguish P. falciparum-only infections from mixed P. falciparum infections. Distinguishing P. falciparum from mixed P. falciparum-vivax infections is important only 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 (e.g. Pf-Pv-pan-pLDH) to detect these increases the complexity of test interpretation. A programme should prioritize these various advantages and disadvantages according to local conditions in the initial stage of making procurement decisions.
c P. falciparum parasites lacking HRP2 +/- HRP3 genes have been identified with high frequency in parts of South America (1). d See references (2–6).e WHO RDT procurement criteria : http://www.who.int/malaria/publications/atoz/rdt_selection_criteria/en/ (accessed 29 september 2015).
For a comprehensive guide to procurement of malaria RDTs extending beyond selection to quantification, budgeting, technical specifications, management of tenders, contracts, supply management and monitoring of supplier performance and managing product variations, see reference (7).
Annex s3: selection of an appropriate rdt
An
ne
xes
3130 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
3332 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)
Notes
3332
RDTMalaria_Round6_CoverBlack2.indd 1 10/12/2015 12:03
Global Malaria Programme World Health Organization20, Avenue Appia1211 Geneva 27Switzerland
[email protected]/malaria
FINDCampus BiotechBuilding B2, Level 09, Chemin des Mines1202 Geneva, SwitzerlandP.O. Box 87CH - 1211 Geneva 20
T: + 41 (22) 710 05 [email protected]
ISBN 978 92 4 151004 2
