List of HIV Diagnostic test kits and equipments classified ...

1 Version 458 July 2022 Manufacturer Product Catalogue numberProduct NameNumber of tests per kit Initial SensitivityFinal SpecificityManufacturer AnalyteSpecimen TypeAnticipated Shelf life (months)/Storage temperature EligibilityWHO or GHTF countries IHI-T402WA*(previously IHI-T402W)ABON HIV 1/2/O Tri-Line HumanImmunodeficiency Virus Rapid Biopharm(Hangzhou) Co. , PR ChinaDiscriminationbetweenHIV-1 andHIV-2antibodiesSerum/Plasma/Whole Blood24 months2 to 30 CWHO PQ IHI-T402WG*ABON HIV 1/2/O Tri-Line HumanImmunodeficiency Virus Rapid Biopharm(Hangzhou) Co. , PR ChinaDiscriminationbetweenHIV-1 andHIV-2antibodiesSerum/Plasma/Whole Blood24 months2 to 30 CWHO PQ IHI-T402WB*ABON HIV 1/2/O Tri-Line HumanImmunodeficiency Virus Rapid Biopharm(Hangzhou) Co.

2 , PR ChinaDiscriminationbetweenHIV-1 andHIV-2antibodiesSerum/Plasma/Whole Blood24 months2 to 30 CWHO PQ IHI-T402WC*ABON HIV 1/2/O Tri-Line HumanImmunodeficiency Virus Rapid Biopharm(Hangzhou) Co. , PR ChinaDiscriminationbetweenHIV-1 andHIV-2antibodiesSerum/Plasma/Whole Blood24 months2 to 30 CWHO PQ 7D2342*207D2343*1007D2343 SET*7D2343 SETS*Serum/Plasma/Whole Blood18 months2 to 30 Abbott Diagnostic Medical Co. Ltd, Matsudo, JapanHIV 1/2 antibodies combined detection1 chase buffers, specimen dropper for serum/plasma, whole bloodList of HIV Diagnostic test kits and equipments classified according to the Global Fund Quality Assurance Policy According to Global Fund Quality Assurance Policy for Diagnostic Products ( ), in force since 1st March 2011, Grant Funds may only be used to procure HIV RDTs if they have been.

3 Criterion 1- prequalified by the WHO Prequalification of In Vitro Diagnostics Programme, or Criterion 2- authorized for use by one of the Regulatory Authorities of the Founding Members of GHTF when stringently assessed (high risk classification), Criterion 3- acceptable for procurement using Grant Funds, as determined by the Global Fund, based on the advice of the WHO Expert Review Panel Categories falling under Criterion-1 and -3In-Vitro Diagnostic Products with respect to HIV, tuberculosis and malaria and to hepatitis B, hepatitis C and syphilis co-infections, as well as IVDs providing information that is critical for patient treatment of these diseases, such as testing for G6PD deficiencyCategories falling under Criterion-2 All under Criterion-1 excluding HIV Self Testing The list is an overview of HIV RDTs to assist Principal Recipients (PRs)

4 Of Global Fund grants to identify the status of HIV RDTs according to the Global Fund Quality Assurance Policy. It includes products recommended for use after technical evaluation by WHO Prequalification of Diagnostics Programme, Regulatory Authoritities of GHTF f0unding members and the WHO hosted Expert Review Panel. The list is not exhaustive; PRs can procure product(s) not listed below as long as PRs demonstrate that the product is compliant with one of the above mentioned requirements. Products prequalified by list is updated regularly based on evidence received by the Global Simple assays/Rapid Diagnostic Tests (RDTs)(not intended to be used as a donor screening tests unless otherwise specified)CommentsProduct codes superscripted with a * (star) mark indicates that product is WHO months2 to 30 C Abbott Diagnostic Medical Co.

5 Ltd, Matsudo, JapanDetermine HIV-1/2 HIV 1/2 antibodies combined detectionSerum/Plasma/Whole Blood100%Safety lancets, alcohol swabs, specimen droppers(for fingerstick whole blood), 2 chase buffers, specimen dropper for serum/plasma, whole bloodIf whole blood: lancets,alcohol swabs, chase buffer(7D2243),EDTA capillarytubes (7D2227).serum/plasma: requiresprecision pipette plus buffers, specimen dropper for serum/plasma, whole bloodWHO PQKit of 10 cards of 10 tests, 1 bottle of chase buffer, 100 capillary tubes & 100 blood lancetsKit of 10 cards of 10 tests, 1 bottle of chase buffer, 100 capillary tubes & 100 blood lancets (safety)Determine HIV-1/2 SET100100%Safety lancets, specimen droppers(for fingerstick whole blood)

6 , 2 chase buffers, specimen dropper for serum/plasma, whole bloodLIST OF Diagnostic TEST KITS FOR HIVclassified according to the GF QA PolicyHIV Simple Assay1/59 Manufacturer Product Catalogue numberProduct NameNumber of tests per kit Initial SensitivityFinal SpecificityManufacturer AnalyteSpecimen TypeAnticipated Shelf life (months)/Storage temperature EligibilityWHO or GHTF countries HIV Simple assays/Rapid Diagnostic Tests (RDTs)(not intended to be used as a donor screening tests unless otherwise specified)CommentsProduct codes superscripted with a * (star) mark indicates that product is WHO prequalified12chase buffers, specimen dropper for serum/plasma, whole blood7D2846207D28471007D2842 *Determine HIVE arly Detect(former Alere HIV Combo)20100% Abbott Diagnostic Medical Co.

7 Ltd, Matsudo, JapanDiscrimination between HIV 1/2 antibodies combined detection and HIV1- p24 antigenSerum/Plasma/Whole Blood18 months2 to 30 C7D2843 *Determine HIVE arly Detect(former Alere HIV Combo)100100% Abbott Diagnostic Medical Co. Ltd, Matsudo, JapanDiscrimination between HIV 1/2 antibodies combined detection and HIV1- p24 antigenSerum/Plasma/Whole Blood18 months2 to 30 C7D2843 SET *Determine HIVE arly Detect(former Alere HIV Combo)100100% Diagnostic Medical Co. Ltd, Matsudo, JapanDiscrimination between HIV 1/2 antibodies combined detection and HIV1- p24 antigenSerum/Plasma/Whole Blood18 months2 to 30 C7D2843 SETS *Determine HIVE arly Detect(former Alere HIV Combo)100100% Diagnostic Medical Co.

8 Ltd, Matsudo, JapanDiscrimination between HIV 1/2 antibodies combined detection and HIV1- p24 antigenSerum/Plasma/Whole Blood18 months2 to 30 C03FK17*Bioline HIV-1/2 between HIV1 and HIV-2 antibodiesSerum/Plasma/Whole Blood24 months 1 to 30 C03FK16 *2503FK10 * 30 Kit of 10 cards of 10 tests, 1 bottle of chase buffer, 100 capillary tubes & 100 blood lancetsWHO PQWHO (CE mark)Discrimination between HIV 1/2 antibodies combined detection and HIV1- p24 antigen18 months2 to 30 CIf whole blood: lancets,alcohol swabs, chase buffer(7D2243),EDTA capillarytubes (7D2227).If serum/plasma: requiresprecision pipette plus lancets, alcohol swabs,capillary tube, chase bufferKit of 10 cards of 10 tests, 1 bottle of chase buffer, 100 capillary tubes & 100 blood lancetsAlere HIV Combo100% Alere Medical Co.

9 Ltd, Matsudo, JapanSerum/Plasma/Whole BloodIf whole blood: lancets,alcohol swabs, chase buffer(7D2243),EDTA capillarytubes (7D2222).If serum/plasma: requiresprecision pipette plus whole blood: lancets,alcohol swabs, chase buffer(7D2243),EDTA capillarytubes (7D2222).If serum/plasma: requiresprecision pipette plus whole blood: lancets,alcohol 03FK10: lancets, capillarypipettes, alcohol Blood24 months1 to 30 CAbbott Diagnostics Korea Inc(former Standard Diagnostics) Giheung-gu,Yongin-si, between HIV1 and HIV-2 antibodiesBioline HIV-1/2 OF Diagnostic TEST KITS FOR HIVclassified according to the GF QA PolicyHIV Simple Assay2/59 Manufacturer Product Catalogue numberProduct NameNumber of tests per kit Initial SensitivityFinal SpecificityManufacturer AnalyteSpecimen TypeAnticipated Shelf life (months)/Storage temperature EligibilityWHO or GHTF countries HIV Simple assays/Rapid Diagnostic Tests (RDTs)(not intended to be used as a donor screening tests unless otherwise specified)

10 CommentsProduct codes superscripted with a * (star) mark indicates that product is WHO prequalified12chase buffers, specimen dropper for serum/plasma, whole bloodWJ-1810*WJ-1810E *WJ-1810EL*WJ-18S10*WJ-18S10E*WJ-18S10EL *WJ-1850*WJ-1850E *WJ-1850EL*WJ-18S50 *WJ-18S50E*WJ-18S50EL*90-1010 *2490-1013 *2490-1021 *4890-1022 *4890-1038 *4890-1064 *4872330 *5072327 *2572347 *25 Genie Fast HIV 1/2100% Laboratories, Marnes La Coquette France and Steenvoorde, FranceHIV 1/2 antibodies (group M and O)Serum/Plasma/Venous and Capillary Whole Blood18 months2 to 30 Cwith support materials:diluent and disposable pipetteswith support materials:diluent, disposable pipette, microsafes, lancets,alcohol swabsWHO 1/2 antibodies combined detection24 T/kit; 24T/kit with supportmaterials; If 90-1010: lancets,alcohol swabs, precisionpipette plus T/kit.