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UltraRapidDiagnosticTestingEarlyInfantHIVDiagnosis
PaoloMaggioreICREID
March12th,2018AddisAbaba
1. Public health case for point-of-care early infant HIV diagnosis
2. Implementation strategies
3. Financial case
Agenda
Thougheffortstoscale-upconventionalEIDtestinghaveincreasedaccess,longturnaroundtimes(TAT)ofresultavailabilityandreceiptbycaregiverunderminetheseefforts
17
17
26
26
7
7
6
32
32
19
19
14
14
4
6
2
9
0
7
0
2
0 20 40 60
Cam2016- Mar2017/Biker
Cam2016- Mar2017/SMS
Malawi2016/R4H
Malawi2016/SMS
Malawi2017/R4H
Malawi2017/SMSRaspPi
Kenya2017
SampleCollectiontoLabLabtoTestDateTesttoFacilityReceipt
0
11.5
20
23
26
7
28
14
23
5
0 10 20 30 40 50 60
Facility1
Facility2
Facility3
Facility4
Facility5
Facility6
Facility7
Facility8
Facility9
Facility10
TurnaroundTime(Days)
SampleCollectiontoReceivedinLabReceivedinLabtoTestDateTestDatetoDispatchDispatchtoFacilityReceiptFacilityReceipttoCaregiverReceipt
Alereqused atbaselineaccountsforTAT≤1day
Conventional testingwasavailableon-site
Referralsitessendingsampletoreferencelabforconventionaltesting
CountryXiNov2016toApr2017
2014 201820162013 2015 2017 2019
Assay Evaluator Sampletype
Sensitivity (95%CI) Specificity(95%CI)
ARDx qWHOPQCDC/NHLS WB 98.67% (95.27-99.84) 100.00% (97.59-100.00)
EIDConsortium WB 99.00%(96.45-99.88) 99.97%(99.83-100.00)
Xpert
WHOPQCDC/NHLS WB 98.86%(93.83-99.97) 100.00%(97.55-100.00)
EIDConsortium WB 96.79%(92.68-98.95) 99.91%(99.76-99.97)
WHOPQCDC/NHLS DBS 99.34% (96.40-100.00) 100.00%(97.60-100.00)
TwoPOCEIDdeviceshavebeenshowntohavehighdiagnosticaccuracyandhavebeenavailablesince2016
CepheidGeneXpert AbbottRapidDiagnosticsq
Inbothstudysettingsandroutineuseacrosscountries,POCEIDdramaticallyincreasesthenumberofinfantsonARTandreducesthetimetoinitiation
Country Setting Device/Sample
#ofsites n %resultreturntocaregiver
TATresultreturn
%ARTinitiation TATARTInitiation
≤30#days
Sameday
≤60days
Sameday
Mozambique(Maputo,Sofala)
cRCT AlereQ,WB
SOC - 8 1876 0.32% 0% 125 12.8%NA
127
POC- 8 2034 98.7% 98.2% 0 89.7% 0
Malawi Observa-tionalpre/post
AlereQ,WB
7pre 963 18.1% 0% 56 41.9% 43.8% 38
7post 789 100% 99.5% 0 91.1% 70.7% 0
#MozambiqueSOC:7.2%within60days;Malawipre:41%within60days.NA=notavailable
Nine-country(EGPAF)
M&E AlereQ,WB&Xpert,WB
SOC – 96 2,900 20.9% 0% 55 43.2% 0% 49
POC– 245 13,201 99.8% 69.8% 0 91.8% 66.7% 0
M&E– RoutineUse
StudyUse
1. Public health case
2. Implementation strategies
3. Financial case
Agenda
0123456789
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952
369
787
110
4512
1913
9315
6717
4119
1520
8922
6324
3726
1127
8529
5931
3333
0734
8136
5538
2940
0341
7743
51
EIDTestsp
erDay.
IndividualFacilities
Country#2
0
2
4
6
8
10
12
14
16
18
20
1 65 129
193
257
321
385
449
513
577
641
705
769
833
897
961
1025
1089
1153
1217
1281
1345
1409
1473
1537
1601
EIDTestsp
erDay
IndividualFacilities
Country#4
-1
1
3
5
7
9
11
13
15
1 34 67 100
133
166
199
232
265
298
331
364
397
430
463
496
529
562
595
628
661
694
EIDTestsp
erDay
IndividualFacilities
Country#3
0
20
40
60
80
100
120
1 72 143
214
285
356
427
498
569
640
711
782
853
924
995
1066
1137
1208
1279
1350
1421
1492
1563
1634
EIDTestsp
erDay
IndividualFacilities
Country#1
Amajority(>50%)ofHEIsareconcentratedinarelativelysmallproportionofsites(between67- 188sitespercountry),allowingahigh-yieldplacementstrategy
80%ofpatientsat26%ofsites10%ofsitesaccountfor59%ofpatients
5%ofsites=47%ofpatients1%ofsites=24%ofpatients
80%ofpatientsat36%ofsites10%ofsitesaccountfor47%ofpatients
(5%ofsites=33%ofpatients1%ofsites=13%ofpatients)
80%ofpatientsat42%ofsites10%ofsitesaccountfor39%ofpatients
(5%ofsites=26%ofpatients1%ofsites=9%ofpatients)
80%ofpatientsat19%ofsites10%ofsitesaccountfor69%ofpatients
(5%ofsites=55%ofpatients1%ofsites=25%ofpatients)
AcombinationofimplementationstrategiescanbeusedtoincreaseaccesstoPOCtestingwhileoptimizingdeviceutilizationrates
8
Stand-AloneSitesReceivesamplesdirectlyfromclientsand
performPOCEIDtestsonsite
Hub-and-SpokeNetworksHubsitesprovidetestingforpatientsatthatsiteandforspokesites.
Nearbyspokesitessendsamplestothehubsitesfortesting
Multiple-Entry-PointSitesReceivesamplesfromdifferentunitsorwardswithin
thesamehealthfacility
POCEID
Hub
Spoke Spoke
POCEID
IntegratedTestingSitesProcessdifferenttypesofPOCtests
(e.g.EID,TB,other)
Nutritionunit
POCEID
Pediatricward
MCHclinic
EID POC TB
Other
Hub-and-spoke:CourtesyEGPAF
WhileinfantsenrolledinPMTCTreceiveanHIVtestresultby2-monthsofage,thosenotenrolledintreatmentprogramsaremorelikelytobeinfectedandunlikelyeverbetested
AstudyinUgandacomparedroutineEIDtestingatalternativeentrypoint:68%ofHIV+ofinfantswerefoundoutsidethePMTCTprogram
0 4 8 12 16
EMTCT
Immunization
Outreach
Outpatient
Inpatient
Nutrition
HIV positivity rate (%)
p=0.000p=0.756p=0.041
p=0.001
p=0.002
• 3,600infantstested:117HIV+• Previousfacilityattendance:~50%ofinfantsin
last12mo.
• Medianageall:7months• MedianageHIV+:11months
Key Findings:• Nutrition and inpatient testing
combined identified the majority (68%) of infants.
Source:Kiyaga Cetal.“Wherehaveallthechildrengone?HighHIVprevalenceininfantsattendingnutritionandinpatiententrypoints.JIAS 2018,21:e25089
1. Public health case
2. Implementation strategies
3. Financial case
Agenda
Theall-incostpertestisimportantforcomparingthecostofdifferentplatforms,butonlytellspartofthestory
At80%utilizationthereagentsmakeupthemajorityofthecostpertestforalldevices• Thedevicecostper
testisminimal,exceptforthemoreexpensivePOCdevicesfromAlereandDRW
• SpecimentransportationmakesupasignificantcostforconventionalEIDtestingdevices
• WastemanagementforCepheidaddscost
$0$5
$10$15$20$25$30$35$40
Ceph
eid-
Omni
DRW-
SAMBA
II
Alere-
Q
Ceph
eid-C
onventional
Ceph
eid-N
ear-PO
C
Ceph
eid-
POC
Roche-
CAP/CT
M
Abbo
tt-
m20
00
Hologic-
Panthe
r
EID- AllinCostpertest-80%Utilization
Reagents(cartridges)- 80% Controls
Non-propriataryconsumables Device
Bundledincrementserviceandmaintenance Logistics
Distributormargins Sampletransportation
Specimencollectioncommodities Healthworkersalarytocollectspecimen
Healthworkersalarytoruntest WasteManagement
DistributorMargin DDP
ConventionalPoint-of-Care
Prod
uctA
Prod
uctB
Prod
uctC
Prod
uctA
Prod
uctB
Prod
uctC
Prod
uctA
Prod
uctB
Prod
uctC
NearPoint-of-Care
SystemdifferencesinthewayconventionalandPOCareimplementedandtheresultingresultreturnedrateshavealargeimpactonthecostperresultreturnedtothepatient
Aweightedaverageofresultsreturnedtothecaregiverorpatientfromeightstudiesis50%• Lostresultsincura
largefinancialcosttorepeattests
• WhenconsideringtheresultreturnedratesPOCEIDtestingbecomesmuchmorecomparablewithconventionalpricing
• TheCepheidGeneXpert couldbeappliedinseveralmodels
$0$10$20$30$40$50$60$70$80
Ceph
eid-
Omni
DRW-
SAMBA
II
Alere-
Q
Ceph
eid-
Conven
tional
Ceph
eid-N
ear-PO
C
Ceph
eid-
POC
Roche-
CAP/CT
M
Abbo
tt-
m20
00
Hologic-
Panthe
r
EID- AllinCostperresultreceived-80%Utilization
Reagents(cartridges)- 80% Controls
Non-propriataryconsumables Device
Bundledincrementserviceandmaintenance Logistics
Distributormargins Sampletransportation
Specimencollectioncommodities Healthworkersalarytocollectspecimen
Healthworkersalarytoruntest WasteManagement
DistributorMargin DDP
CostfromErrors- 80% CostfromLostResults- 80%
ConventionalNearPoint-of-CarePoint-of-Care
Prod
uctA
Prod
uctB
Prod
uctC
Prod
uctA
Prod
uctB
Prod
uctC
Prod
uctA
Prod
uctB
Prod
uctC
AnalysisofacountrypilotresultsindicatethatPOCEIDwaslessexpensivethanconventionaltestingperHIV+infantidentifiedandplacedontreatment2
CostperinfantinitiatedonART• Examiningthecostperinfantinitiatedontreatmentfromthei studyrevealsthatPOC
EIDwaslessexpensivethanconventionalEIDtesting.• ThiseffectwaslargelytheresultoflowerinitiationratesintheSOCarm,compared
withthePOCarmofthestudy,howeverHIVpositivityrateswerealsohigherinthePOCarmofthestudy
POCEIDtestingnearlyeliminates‘missing’resultsandincreasestheproportionofinfantsinitiated,butrequiresequipmentateachsite
Asite-by-siteanalysisofover10kPMTCTsitesineightcountrieswasconductedtodeterminethecostperHIV+infantinitiatedonARTateachsiteusingPOCEID.ThecostperHIV+infantinitiatedusingPOCranged from$551atthehighest-volumesiteto$35,882atthelowest-volumesite.
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