（英文）行業(yè)資料 WHO lot testing programme for malaria rapid diagnostic tests (RDTs),2007–2022

WHOLOTTESTINGPROGRAMMEFORMALARIARAPIDDIAGNOSTICTESTS(RDTs)

2007–2022

WHOLOTTESTINGPROGRAMMEFORMALARIARAPIDDIAGNOSTICTESTS(RDTs)

2007–2022

WHO/UCN/GMP/2023.04

?WorldHealthOrganization2023

Somerightsreserved.ThisworkisavailableundertheCreativeCommonsAttribution-NonCommercial-ShareAlike3.0IGOlicence(CCBY-NC-SA3.0IGO;/licenses/by-nc-sa/3.0/igo).

Underthetermsofthislicence,youmaycopy,redistributeandadapttheworkfornon-commercialpurposes,providedtheworkisappropriatelycited,asindicatedbelow.Inanyuseofthiswork,thereshouldbenosuggestionthatWHOendorsesanyspecificorganization,productsorservices.TheuseoftheWHOlogoisnotpermitted.Ifyouadaptthework,thenyoumustlicenseyourworkunderthesameorequivalentCreativeCommonslicence.Ifyoucreateatranslationofthiswork,youshouldaddthefollowingdisclaimeralongwiththesuggestedcitation:“ThistranslationwasnotcreatedbytheWorldHealthOrganization(WHO).WHOisnotresponsibleforthecontentoraccuracyofthistranslation.TheoriginalEnglisheditionshallbethebindingandauthenticedition”.

AnymediationrelatingtodisputesarisingunderthelicenceshallbeconductedinaccordancewiththemediationrulesoftheWorldIntellectualPropertyOrganization

(/amc/en/mediation/rules/

).

Suggestedcitation.WHOlottestingprogrammeformalariarapiddiagnostictests(RDTs),2007–2022.Geneva:WorldHealthOrganization;2023(WHO/UCN/GMP/2023.04).Licence:

CCBY-NC-SA3.0IGO

.

Cataloguing-in-Publication(CIP)data.CIPdataareavailableat

/iris

.

Sales,rightsandlicensing.TopurchaseWHOpublications,see/publications/book-

orders.Tosubmitrequestsforcommercialuseandqueriesonrightsandlicensing,see

/copyright

.

Third-partymaterials.Ifyouwishtoreusematerialfromthisworkthatisattributedtoathirdparty,suchastables,figuresorimages,itisyourresponsibilitytodeterminewhetherpermissionisneededforthatreuseandtoobtainpermissionfromthecopyrightholder.Theriskofclaimsresultingfrominfringementofanythird-party-ownedcomponentintheworkrestssolelywiththeuser.

Generaldisclaimers.ThedesignationsemployedandthepresentationofthematerialinthispublicationdonotimplytheexpressionofanyopinionwhatsoeveronthepartofWHOconcerningthelegalstatusofanycountry,territory,cityorareaorofitsauthorities,orconcerningthedelimitationofitsfrontiersorboundaries.Dottedanddashedlinesonmapsrepresentapproximateborderlinesforwhichtheremaynotyetbefullagreement.

Thementionofspecificcompaniesorofcertainmanufacturers’productsdoesnotimplythattheyareendorsedorrecommendedbyWHOinpreferencetoothersofasimilarnaturethatarenotmentioned.Errorsandomissionsexcepted,thenamesofproprietaryproductsaredistinguishedbyinitialcapitalletters.

AllreasonableprecautionshavebeentakenbyWHOtoverifytheinformationcontainedinthispublication.However,thepublishedmaterialisbeingdistributedwithoutwarrantyofanykind,eitherexpressedorimplied.Theresponsibilityfortheinterpretationanduseofthemateriallieswiththereader.InnoeventshallWHObeliablefordamagesarisingfromitsuse.

CONTENTS

ABOUT1

MALARIARDTLOTTESTINGRESULTS,2022(INITIALTESTING)2

MALARIARDTLOTTESTINGRESULTS,2022(NON-ROUTINETESTING)3

MALARIARDTLOTTESTINGRESULTS,2007–2022(CUMULATIVESUMMARYBYPRODUCT)4

MALARIARDTLOTTESTINGRESULTSSUMMARY,2007–202210

PRE-QUALIFIEDPRODUCTSSUBMITTEDFORMALARIARDTLOT-TESTING,202211

ANNUALDEMANDFORMALARIARDTLOTTESTING,2007-202212

REQUESTERSANDRECIPIENTCOUNTRIESOFLOT-TESTEDMALARIARDTs,202214

WHOLOTTESTINGPROGRAMMEFORMALARIARAPIDDIAGNOSTICTESTS(RDTs),(20072022)1

ABOUT

TheWHOlottestingprogrammeformalariarapiddiagnostictests(RDTs)isanindependentqualitycontrolsystemdesignedtoevaluatelottolotvariationinperformanceofmalariaRDTs.ThepurposeofthisprogrammeistoensurethatonlythehighestqualitymalariaRDTlotsareprocuredandusedinendemiccountries.Currently,theResearchInstituteforTropicalMedicine(RITM)(Philippines)servesastheonlyWHO-sponsoredandmonitoredlaboratoryevaluatingRDTlotsaccordingtoWHOprocedures,usingwell-characterizedandstandardizedparasitesamplesforqualitycontrolofmalariaRDTs.Historically,WHOhascommissionedindependent,externalqualitylaboratoryassessmentsoftheNationalInstituteofMalariaResearch(NIMR),NewDelhi,IndiaandtheANDICentreofExcellenceforMalariaDiagnosis,UniversityofLagos,NigeriaandtheselaboratorieshavebeenfoundtobecompliantwithWHOmalariaRDTlottestingstandardoperatingprocedures.TheselaboratoriesconductlotverificationforRDTbatchesimportedintotheirrespectivecountriesandtheyarenotaccountedforinthisreport.Representativesfromtheselaboratoriesshouldbecontactedforinformationregardingtheir

ongoingcompliancewithWHOproceduresandavailabilityoflottestingservices(India:

nks.nimr@;Nigeria:

andimalariacentre@.ng

).

RDTsaresentfromanywhereintheworldtoRITMonrequestbyMinistriesofHealth,nationalmalariacontrolprogrammes,NGOs,RDTmanufacturers,procurementagenciesandother

internationalorganizations.LottestingisperformedatRITMaccordingtoproceduresoutlined

MethodsManualforLaboratoryQualityControlTestingofMalariaRDTs()

.RDTlotsare

testedwithinfourteendaysofreceipt.MalariaRDTlottestingresultsprovideinformationaboutadequacyofRDTsforclinicaluse,andanomaliesnotedduringtestingthatcanalsobeencounteredduringuseinthefield.ReportsprovidedtolottestingrequestersincludephotosoftheRDTstested,observations(e.g.,redbackground,fainttestline,invalidresult,etc.),andresultsoftheaccessoryassessment.

ThisreportisupdatedannuallybythestaffoftheMalariaRDTLotTestingLaboratory,Research

InstituteforTropicalMedicine(RITM),Philippines(

ritm.malariardtlt@

)andreviewedbytheresponsibleWHOtechnicalofficer

(malaria_rdt@

).Furtherinformationabout

procedurestorequestRDTlottestingservicesaswellasotherrelatedresourcesareavailable

at

GlobalMalariaProgramme().

WHOLOTTESTINGPROGRAMMEFORMALARIARAPIDDIAGNOSTICTESTS(RDTs),(20072022)2

MALARIARDTLOTTESTINGRESULTS,2022

(INITIALTESTING)

ProductNames

CatalogNo.

Manufacturer

No.of

lots

tested

No.oflotspassed

AdvDxMalariaPfRapidMalariaAgDetectionTest

00-DKM-RK-MAL-ADX-004-024

AdvyChemicalPvt.Ltd.

12

11

BiocreditMalariaAg.P.f/P.v(pLDH/pLDH)

C61RHF25

Rapigen,Inc.

2

2

BiolineMalariaAgPf

05FK50

AbbottDiagnosticsKorea,

Inc.

13

13

BiolineMalariaAgPfPOCT

05FK53

4

4

BiolineMalariaAg.P.f/P.f/P.v

05FK63

9

9

BiolineMalariaAg.P.f/P.v

05FK83

1

1

BiolineMalariaAg.P.f/Pan

05FK60

3

3

EzDxMalariaPan/PfRapidTestDetectionKit

00-DKM-RK-MAL-EDX-001-025

AdvyChemicalPvt.Ltd.

1

0

FalciVaxDeviceRapidTestforMalariaPv/Pf

503010025

ZephyrBiomedicals

1

1

FirstResponseMalariaAgP.falciparum(HRP2)CardTest

PI13FRC25

PremierMedicalCorporationPvt.Ltd.

81

81

FirstResponseMalariaAgPf/PvCardTest

PI19FRC25

12

12

FirstResponseMalariaAgpLDH/HRP2ComboCardTest

PI16FRC25

30

30

PI16FRC25CE

3

3

PI16FRC25s

1

1

MeriscreenMalariaP.f/P.vAg

MFLRPD-03

MerilDiagnostics,Pvt.Ltd.

3

3

ParacheckPfDevice-RapidTestforP.falciparumMalaria(Ver3)

302030010

OrchidBiomedicalSystems

20

20

302030025

57

57

ParaHITf.ver1.0RapidTestforP.falciparumMalariaDevice

55IC104-25

ArkrayHealthcarePvt.Ltd.

74

74

55IC104-10

10

10

ParascreenDeviceRapidTestforMalariaPAN/Pf

503030025

ZephyrBiomedicals

6

6

SDBiolineMalariaAgP.f/P.vPOCT

05FK83

StandardDiagnostics,Inc.

1

1

STANDARDQMalariaPfAg

09MAL10D

SDBiosensor,Inc.

2

2

STANDARDQMalariaPf/PANAg

09MAL30D

3

3

STANDARDQMalariaPf/PvAg

09MAL20D

1

1

TOTAL

350

348

WHOLOTTESTINGPROGRAMMEFORMALARIARAPIDDIAGNOSTICTESTS(RDTs),(20072022)3

MALARIARDTLOTTESTINGRESULTS,2022

(NON-ROUTINETESTING)

Atotalof23lotswerereceivedfornon-routinetesting.Sixteen(16)oftheseweresenttotheRITMfortestingafterbeingretrievedfromfieldsitesinRwanda(6lots)andhealthfacilitiesinMalawi(10lots)duetocomplaintsontheirperformance.Twoofthe6lotsfromRwandafailedtheQCassessmentduetoinsufficientbufferwhichdidnotallowtesting.ConcerninglotsthatoriginatedfromMalawi,9outof10lotspassedtheQCassessment;1lotreturnedfalsepositiveresults(3/13)onnegativeQCsamples.

Theother7lotswereforconfirmatorytestingafterdeferredQCassessmentresultsfromNIMR,India.Four(4)ofthe7lotsobtainedfailedQCassessmentresultsintheconfirmatorytestingbecausethelotsshowednegativeresultsonPfQCsamples(3/4samples),consistentwiththeprimarytestingresultsfromNIMR.

ProductNames

CatalogNo.

Manufacturer

No.oflotstested

No.oflotspassed

AdvantageMALCard

IRI21050

DiagnosticEnterprises

1

0

ErbaQik?MalariaPANAntigenTest

132213

TransasiaBio-MedicalsLimited

3

0

EdgeXpressMalariaPanAntigenDetectionTest

EL011C25

EdgeLabsLLP

3

3

SDBiolineMalariaAgP.f/PANPOCT

05FK67

StandardDiagnosticsInc.

6

4

FirstResponseMalariaAg.P.falciparum(HRP2)CardTest

PI13FRC25

PremierMedicalCorporationPrivateLimited

10

9

TOTAL

23

16

WHOLOTTESTINGPROGRAMMEFORMALARIARAPIDDIAGNOSTICTESTS(RDTs),(20072022)4

MALARIARDTLOTTESTINGRESULTS,2007–2022(Cumulativesummarybyproduct)

Manufacturer

CatalogueNo.

Productname

No.

lotstested

Year(s)tested

Pass

Ratet

(%)

Comment

(s)

AbbottDiagnosticsKorea,Inc.

05FK50/53

BiolineMalariaAgPf

39

2021

100

AbbottDiagnosticsKorea,Inc.

05FK60/63

BiolineMalariaAgPf/PAN

22

2021

100

AbbottDiagnosticsKorea,Inc.

05FK83

BiolineMalariaAg.P.f/P.v

1

2022

AbbottDiagnosticsKorea,Inc.

05FK123

BiolineMalariaAg.P.f/P.f/P.v

9

2022

AccessBioInc.

RMLC-02571/RMLM-02571(G0121)

CareStart?MalariaPf/PAN(pLDH)AgRDT

11

2008-2009-

2016-2017

91

1lotfailed

initial

testingin

2016

AccessBioInc.

RMOM-02571/RMOU-02571(G0141/141-SK)

CareStart?MalariaPf(HRP2)AgRDT

866

2010-2011-

2012-2013-

2014-2015-

2016-2017-

2018-2019-2021

100

AccessBioInc.

RMRM-01071/RMRM-02571/RMRU-02571(G0131/131-SK)

CareStart?MalariaPf/PAN

(HRP2/pLDH)Ag

ComboRDT

349

2007-2008-

2009-2010-

2011-2012-

2013-2014-

2015-2016-

2017-2018-

2019-2021

98

6lotsfailed

initial

testingin

2016

AccessBioInc.

RMVM-01071/RMVM-02571/RMVC-02571(G0161)

CareStart?MalariaPf/Pv(HRP2/pLDH)AgComboRDT

57

2012-2013-

2014-2015-

2016-2017-

2018-2019-2021

100

AccessBioInc.

RMWM-02571

CareStart?MalariaPf/VOM

(HRP2/pLDH)Ag

ComboRDT

2

2018

100

AccessBioInc.

G0221

CareStart?Malaria/PregnancyCombo

(HRP2/pLDH/HCG)

1

2015

100

AccessBioInc.

G0231

CareStart?MalariaScreen

16

2008-2009

100

AccessBioInc.

RMNM-02571/RMNC-02571(G0111)

CareStart?MalariapLDH(Pan)

64

2011-2014-

2015-2016-

2017-2018-

2019-2021

100

AccessBioInc.

RMPC-02571

(G0181/181-

ET/181-SK)

CareStart?MalariaHRP2/pLDH(Pf)

37

2013-2014-

2015-2016

100

AdvyChemical

PrivateLimited

RKMAL001

EzDx?MalariaPan/PfRapidtestdetectionKit

9

2011-2013

100

WHOLOTTESTINGPROGRAMMEFORMALARIARAPIDDIAGNOSTICTESTS(RDTs),(20072022)5

Manufacturer

CatalogueNo.

Productname

No.

lotstested

Year(s)tested

Pass

Ratet

(%)

Comment

(s)

AdvyChemical

PrivateLimited

RKMAL003

EzDx?Malaria

Pv/PfRapidMalariaantigendetectiontest

2

2013

100

AdvyChemical

PrivateLimited

00-DKM-RK-MAL-ADX-004-025

AdvDx?MalariaPfRapidMalariaAgDetectionTest

24

2020-2021-2022

96

1lotfailedinitialtestingin2022.

AdvyChemical

PrivateLimited

00-DKM-RK-MAL-EDX-001-025

EzDxMalariaPan/PfRapidTestDetectionKit

1

2022

1

ARKRAYHealthcarePvtLtd*

55IC104-10/25/50

Parahit?fVer1.0RapidTestforP.falciparumMalaria-Device

199

2013-2014-

2015-2016-

2017-2018-

2019-2020-

2021-2022

100

ARKRAYHealthcarePvtLtd*

55IC102-10

ParaHIT-f(device)

7

2007-2009

100

ARKRAYHealthcarePvtLtd*

55IC201-10

ParaHIT-Total

(dipstick)

1

2008

0

1lotfailedinitialtestingin2008

ArtronLaboratoriesInc.

A03-18-322

MalariaPf./Pan

Antigen(MAL

Pf/Pan)TestKit

1

2016

100

ArtronLaboratories,Inc.

A03-12-322

MalariaP.f/Pv(MalPf/Pv)AntigenTestKit

1

2016

100

Athenese-DxPvt.Ltd.

AR0112C

TRUSTlineMalariaPf/PvAg

1

2021

100

BioFootprintsHealthcarePvt.Ltd.

MTR00250

Mytest?MalariaAgPf/Pan

2

2015

100

BioNoteInc.Korea

RG19-11

BionoteMalariaP.fAgRapidTestKit

2

2015

100

BioNote,Inc.

RG19-08

BIONOTEMALARIAP.f&PanAgRapidTestKit

1

2014

100

Clearview

VB11

ClearviewMalariaCombo

1

2010

100

CTKBiotech,Inc.

R0112C

OnSiteMalariaPf/PvAgRapidTest

8

2013-2014

100

CTKBiotech,Inc.

R0113C

OnSiteMalaria

Pf/PanAgRapid

Test

1

2012

100

CTKBiotech,Inc.

R0114C

OnSiteMalariaPfAgRapidTest

6

2007-2013-2014

100

DeangelBiologicalEngineeringCo.,Ltd.

MAL-MD02

MalariaPf/PanRapidTestDevice

2

2015-2017

100

DeangelBiologicalEngineeringCo.,Ltd.

MAL-ND02

MalariaPf/PvRapidTestDevice

1

2017

100

Diagnostic

Enterprises

IRI21050

AdvantageMAL

Card

1

2022

0

1lotfailedRITMconfirmatorytestingin2022.

WHOLOTTESTINGPROGRAMMEFORMALARIARAPIDDIAGNOSTICTESTS(RDTs),(20072022)6

Manufacturer

CatalogueNo.

Productname

No.

lotstested

Year(s)tested

Pass

Ratet

(%)

Comment

(s)

DiamedAG

710024

OptiMAL-IT

1

2008

100

EdgeLabsLLP

EL011C25

EdgeXpressMalariaPanAntigenDetectionTest

3

2022

100

GuangzhouWondfoBiotechCo.Ltd.

W56-C(4.0mm)

OnestepMalariaPf/Panwholebloodtest

4

2008-2009

100

HemaDiagnostic

Systems,LCC

MAL-PFV-CAS25

Rapid1-2-3HemaCassetteMalaria(PFV)

3

2015

100

HumanGmbH

58024

HexagonMalaria

Combi

1

2008

0

1lotfailedinitialtestingin2008

ICTDiagnostics

ML02

ICTMalariaComboCassetteTest

68

2007-2008-

2009-2010-

2011-2012

88

8lotsfailedinitialtesting;2007(1),2008(1),2011(2)&2012(4)

ICTINTERNATIONAL

ML01

ICTMALARIAP.F.CASSETTETEST

249

2007-2008-

2009-2010-

2011-2014

100

ICTINTERNATIONAL

ML03

ICTMALARIADUALTEST

2

2012-2014

100

InnovitaBiologicalTechnologyCo.Ltd.

YF503C

MalariaPf/PanAntigenWholeBloodTestCassette(ColloidalGold)

2

2017-2018

50

1lotwasdeferredduringinitialtestingin2007.Noconfirmatorytestingresultavailable.

J.Mitra&Co.Pvt.Ltd.

IR016025

AdvantageP.f.

MalariaCard

15

2013-2014-

2015-2017-2018

100

J.Mitra&Co.Pvt.Ltd.

IR211025

AdvantageMalariaCard

1

2010

100

J.Mitra&Co.Pvt.Ltd.

IR231025

AdvantageMalariaPan+PfCard

4

2016-2018

100

Lumiquick

DiagnosticsInc.

71050

QuickProfile?

MalariaPf/Pv

AntigenTest

3

2013-2016

100

Lumiquick

Diagnostics,Inc.

71063

QuickProfile?MalariaPf/PanTest

2

2016

100

MerilDiagnostics,Pvt.Ltd.

MFLRDP-03

MeriScreenMalariaPf/PvAg

8

2020-2021-2022

100

NanongEgensBiotechnologyCo.,LTD.

Inf-73

MalariaP.f./Pv

AntigenTest

Cassette

2

2011-2013

100

NanongEgensBiotechnologyCo.,LTD.

Inf-76

MalariaP.f.AntigenTestCassette

2

2011-2013

100

WHOLOTTESTINGPROGRAMMEFORMALARIARAPIDDIAGNOSTICTESTS(RDTs),(20072022)7

Manufacturer

CatalogueNo.

Productname

No.

lotstested

Year(s)tested

Pass

Ratet

(%)

Comment

(s)

NanongEgensBiotechnologyCo.,LTD.

Nil

QDMalariaAntigenP.f

1

2014

100

OrchidBiomedicalSystems(TulipGroup)

30301025/302030010/302030025

ParacheckPf?

RapidTestforPf

Malaria(Ver.3)

1507

2007-2008-

2009-2010-

2011-2012-

2013-2014-

2015-2016-

2017-2018-

2019-2020-

2021-2022

100

PremierMedical

CorporationLtd.

I13FRC25/25CE/25S/30/30S/35

FirstResponse?MalariaAgP.falciparum(HRP2)CardTest

321

2009-2010-

2011-2012-

2013-2014-

2015-2016-

2017-2018-2019

100

PremierMedical

CorporationLtd.

I16FRC25/25CE/25S/30/30s/40

FirstResponse

Malaria

HRP2/pLDH(Pf/Pan)

172

2010-2011-

2012-2013-

2014-2015-

2016-2017-2018

99

Pvdetection@200parasites/μlfailedin2lotsin2015

PremierMedical

CorporationLtd.

I16MCC10/25

MalacheckMalariaAg(pLDH/HRP2)ComboCardTest

4

2012-2013

100

PremierMedical

CorporationLtd.

PI13FRC25/25CE/26/27/28

FirstResponse

MalariaAg.P.

falciparumHRP2

CardTest

294

2014-2016-

2017-2018-

2019-2020-

2021-2022

100

PremierMedical

CorporationLtd.

PI16FRC25/25CE/25S

FirstResponse

MalariaAg.

pLDH/HRP2ComboCardTest

112

2014-2017-

2018-2019-

2020-2021-2022

100

PremierMedicalCorporationPrivateLtd.

PI19FRC10/10S/25/25S

FirstResponse?MalariaAg.P.f./P.v.CardTest

47

2014-2017-

2019-2020-

2021-2022

96%

RapiGENInc.

C14RHG25

BIOCREDITMalariaAgPf(pLDH)

1

2021

100

RapiGENInc.

C32RHA25

BIOCREDITMalariaAgPf/Pan

(HRPII/pLDH)

4

2018-2020-2021

100

RapiGENInc.

C61RHI25

BIOCREDITMalariaPf/Pv

3

2021-2022

100

SDBiosensor,Inc.

09MAL10D

StandardQMalariaPfAg

78

2020-2021-2022

100

SDBiosensor,Inc.

09MAL20D

StandardQMalariaPf/PvAg

5

2020-2021-2022

100

SDBiosensor,Inc.

09MAL30D

StandardQMalariaPf/PANAg

20

2020-2021-2022

100

SDBioStandardDiagnosticsPVT.LTD,India

05FK60l-40

SDMalariaAg

Pf/Pan

2

2010

100

WHOLOTTESTINGPROGRAMMEFORMALARIARAPIDDIAGNOSTICTESTS(RDTs),(20072022)8

Manufacturer

CatalogueNo.

Productname

No.

lotstested

Year(s)tested

Pass

Ratet

(%)

Comment

(s)

ShenzhenBioeasyBiotechnologyCo.Ltd

YRLG0180102

BioeasyOneStepMalariaP.f/PanTriLineRapidTest

1

2019

100

StandardDiagnosticsInc.

05FK60/61/63/64/65/66/67

SDBIOLINEMalariaAgP.f/Pan

843

2010-2011-

2012-2013-

2014-2015-

2016-2017-

2018-2019-

2020-2021-2022

99

2lotsfailed

initialnon-

routine

testingin

2022.No

confirmatory

results

available.

StandardDiagnosticsInc.(Alere)

05FK120/123

SDBIOLINEMalariaAgP.f/P.f/P.v

43

2014-2015-

2016-2017-

2018-2019-2020

100

StandardDiagnosticsInc.(Alere)

05FK90/93

SDBIOLINEMalariaAgP.f(HRP2/pLDH)

136

2009-2010-

2012-2013-

2014-2015-

2016-2017-2018

-2019

100

Standard

Diagnostics,Inc.

05FK40

SDBiolineMalariaAg

14

2007-2008-

2009-2010

100

Standard

Diagnostics,Inc.

05FK50/51/52/53/54/55/56/57/58/59

SDBIOLINEMalariaAgPf

1846

2009-2010-

2011-2012-

2013-2014-

2015-2016-

2017-2018-

2019-2020-2021

100

2014-6lotsof05FK57failedintervaltestingduetoevaporationofbuffer

Standard

Diagnostics,Inc.

05FK80/81/83/85/86/87

SDBiolineMalariaAgP.f/P.v

474

2010-2011-

2012-2013-

2014-2015-

2016-2017-

2018-2019-

2020-2021-2022

100

Standard

Diagnostics,Inc.

05FK140

AlereMalariaAgPfUltraSensitive

5

2019-2020

100

TransasiaBio-

MedicalsLimited

132213

ErbaQik?MalariaPANAntigenTest

3

2022

0

3lotsfailedRITMconfirmatorytestingin2022.

ZephyrBiomedicals

503010025/10

Parascreen(FalciVax)DeviceRapidTestforMalariaPan/Pf(Device)

26

2007-2008-

2009-2010-

2020-2021

100

ZephyrBiomedicals

503030025

ParaScreenDeviceRapidTestforMalariaPAN

46

2020-2021-2022

100

ZephyrBiomedicals

503040025

ParaBankDeviceRapidTestforMalariaPAN/Pf

5

2020-2021

20

4lotsfailedconfirmatorytestingin2021

ZhuhaiEncodeMedicalEngineeringCo.,Ltd.

IMA432

RAPIQUICKMalariaP.f/PanRapidTestDevice

1

2017

0

1lotfailedinitialtestingin2017

WHOLOTTESTINGPROGRAMMEFORMALARIARAPIDDIAGNOSTICTESTS(RDTs),(20072022)9

Manufacturer

CatalogueNo.

Productname

No.

lotstested

Year(s)tested

Pass

Ratet

(%)

Comment

(s)

TOTAL

8129

tPassrateduringroutineinitialtesting

*PreviouslyknownasSpanDiagnosticsLtd

.

WHOLOTTESTINGPROGRAMMEFORMALARIARAPIDDIAGNOSTICTESTS(RDTs),(20072022)10

MALARIARDTLOTTESTINGRESULTSSUMMARY,2007–2022

From2013uptothelastlong-termtestingdonein2018,nolotshavefailed.Underinitialtesting,since2017nofailureswerenoteduntil2021.In2022,1lotfailedininitialtestingduetounacceptablyhighfalsepositiveagainstnegativeQCsamples.Intotal,8,258lotswereinitiallytestedwith17failures(0.22%)recordedfrom2007topresent.

Year

No.ofnew

products

No.ofnewmanufacturers

No.ofRDTs

lots

No.ofinitial

failures

No.oflongtermfailures

2007

8

7

59

1

1

2008

6

4

139

3

1

2009

2

-

243

0

2

2010

7

3

236

0

0

2011

4

2

365

2

9

2012

4

-

567

4

6

2013

6

1

1083

0

0

2014

2

1

927

0

0

2015

6

3

879

2

0

2016

14

2

797

1

0

2017

4

2

760

1

0

2018

2

1

592

0

0

2019

2

1

294

0

NA

2020

7

2

496

0

NA

2021

3

1

448

1

NA

2022

3

-

342

1

NA

Total

80

30

8258

1

19

WHOLOTTESTINGPROGRAMMEFORMALARIARAPIDDIAGNOSTICTESTS(RDTs),(20072022)11

PRE-QUALIFIEDPRODUCTSSUBMITTEDFORMALARIARDTLOT-TESTING,2022

In2022,theRITMreceived10lotsfrom5differentproductsthatwerenotincludedintheWHOPre-QualifiedListofMalariaRDTs(seelistbelow).Theselotsconstitutedalmost3%ofthetotallotsreceivedfortheyear;7werelot-testedforconfirmatory(fromNIMR)whilethe3weretestedforinitialtesting.

1.BIOCREDITMalariaAgPf/Pv;CatalogNumber-C61RHI25;Manufacturer-RapiGEN,Inc.

2.EzDxMalariaPan/PfRapidTestDetecti