Version 48

29 Mars 2023

List 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 ( https://www.theglobalfund.org/media/5885/psm_qadiagnostics_policy_en.pdf ), in force since 1st March 2011, Grant Funds may only be used to procure HIV RDTs if they have been:
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 -3
In-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 deficiency
Categories 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) 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 https://extranet.who.int/pqweb/sites/default/files/documents/221214_prequalified_IVD_product_list.pdf

The list is updated regularly based on evidence received by the Global Fund.

HIV Simple assays/Rapid Diagnostic Tests (RDTs)

(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark indicates that product is WHO prequalified
Anticipated
Manufacturer Shelf life
Number of Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte Specimen Type (months)/ Comments
tests per kit WHO or GHTF countries
number Storage
temperature

Discrimination
IHI-T402WA * ABON™ HIV 1/2/O Tri-Line Human
Immunodeficiency Virus Rapid Test 40 100.00% 99.70%
ABON Biopharm
(Hangzhou) Co. Ltd.
between
HIV-1 and Serum/Plasma/
24 months
2 to 30°C
12chase buffers, specimen dropper for
serum/plasma, whole blood
WHO PQ
(previously IHI- Device Hangzhou, PR China HIV-2 Whole Blood
T402W) antibodies
Discrimination
Safety lancets, alcohol swabs, specimen
ABON™ HIV 1/2/O Tri-Line Human ABON Biopharm between
IHI-T402WG * Immunodeficiency Virus Rapid Test
Device
40 100.00% 99.70% (Hangzhou) Co. Ltd.
Hangzhou, PR China
HIV-1 and
HIV-2
Serum/Plasma/
Whole Blood
24 months
2 to 30°C
droppers(for fingerstick whole blood), 2 chase
buffers, specimen dropper for serum/plasma,
WHO PQ
whole blood
antibodies
Discrimination
Safety lancets, specimen droppers(for
ABON™ HIV 1/2/O Tri-Line Human ABON Biopharm between
IHI-T402WB * Immunodeficiency Virus Rapid Test
Device
40 100.00% 99.70% (Hangzhou) Co. Ltd.
Hangzhou, PR China
HIV-1 and
HIV-2
Serum/Plasma/
Whole Blood
24 months
2 to 30°C
fingerstick whole blood), 2 chase buffers,
specimen dropper for serum/plasma, whole
WHO PQ
blood
antibodies
Discrimination
ABON™ HIV 1/2/O Tri-Line Human ABON Biopharm between
IHI-T402WC * Immunodeficiency Virus Rapid Test
Device
5 100.00% 99.70% (Hangzhou) Co. Ltd.
Hangzhou, PR China
HIV-1 and
HIV-2
Serum/Plasma/
Whole Blood
24 months
2 to 30°C
1 chase buffers, specimen dropper for
serum/plasma, whole blood
WHO PQ

antibodies
If whole blood: lancets,
7D2342 * Determine™ HIV-1/2
20
100% 99.40%
Abbott Diagnostic Medical Co. HIV 1/2 antibodies Serum/Plasma/ 18 months
alcohol swabs, chase buffer
(7D2243),EDTA capillary
Ltd, Matsudo, Japan combined detection Whole Blood 2 to 30°C tubes (7D2227).
7D2343 * 100 serum/plasma: requires
precision pipette plus tips.
WHO PQ
7D2343SET * Abbott Diagnostic Medical Co. HIV 1/2 antibodies Serum/Plasma/ 18 months
Kit of 10 cards of 10 tests, 1 bottle of chase
buffer, 100 capillary tubes & 100 blood lancets
Determine™ HIV-1/2 SET 100 100% 98.94%
Ltd, Matsudo, Japan combined detection Whole Blood 2 to 30°C Kit of 10 cards of 10 tests, 1 bottle of chase
7D2343SETS * buffer, 100 capillary tubes & 100 blood lancets
(safety)

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV Simple Assay 1/49
 HIV Simple assays/Rapid Diagnostic Tests (RDTs)
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark indicates that product is WHO prequalified
Anticipated
Manufacturer Shelf life
Number of Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte Specimen Type (months)/ Comments
tests per kit WHO or GHTF countries
number Storage
temperature

7D2846 20 Discrimination If whole blood: lancets,

between HIV 1/2 alcohol swabs, chase buffer
Abbott Alere Medical Co. Ltd, Serum/Plasma/ 18 months (7D2243),EDTA capillary
Alere HIV Combo 100% 99.72% antibodies combined GHTF (CE mark)
Matsudo, Japan Whole Blood 2 to 30°C tubes (7D2227).
detection and HIV1- If serum/plasma: requires
7D2847 100 p24 antigen precision pipette plus tips.

Discrimination If whole blood: lancets,

alcohol swabs, chase buffer
Determine HIV between HIV 1/2
7D2842 * Early Detect
(former Alere HIV Combo)
20 100% 99.40%
Abbott Diagnostic Medical Co.
Ltd, Matsudo, Japan
antibodies combined
detection and HIV1-
Serum/Plasma/ 18 months
Whole Blood 2 to 30°C
(7D2243),EDTA capillary
tubes (7D2222).
If serum/plasma: requires
p24 antigen precision pipette plus tips.

Discrimination If whole blood: lancets,

alcohol swabs, chase buffer
Determine HIV between HIV 1/2
7D2843 * Early Detect
(former Alere HIV Combo)
100 100% 99.40%
Abbott Diagnostic Medical Co.
Ltd, Matsudo, Japan
antibodies combined
detection and HIV1-
Serum/Plasma/ 18 months
Whole Blood 2 to 30°C
(7D2243),EDTA capillary
tubes (7D2222).
If serum/plasma: requires
p24 antigen precision pipette plus tips.
WHO PQ

Discrimination
Determine HIV between HIV 1/2
7D2843SET * Early Detect
(former Alere HIV Combo)
100 100% 99.40%
Abbott Diagnostic Medical Co.
Ltd, Matsudo, Japan
antibodies combined
detection and HIV1-
Serum/Plasma/ 18 months
Whole Blood 2 to 30°C
Kit of 10 cards of 10 tests, 1 bottle of chase
buffer, 100 capillary tubes & 100 blood lancets

p24 antigen

Discrimination
Determine HIV between HIV 1/2
7D2843SETS * Early Detect
(former Alere HIV Combo)
100 100% 99.40%
Abbott Diagnostic Medical Co.
Ltd, Matsudo, Japan
antibodies combined
detection and HIV1-
Serum/Plasma/ 18 months
Whole Blood 2 to 30°C
Kit of 10 cards of 10 tests, 1 bottle of chase
buffer, 100 capillary tubes & 100 blood lancets

p24 antigen

Discrimination
03FK17 * Bioline HIV-1/2 3.0 25 99.80% 99.90% between HIV1 and
HIV-2 antibodies
Serum/Plasma/
Whole Blood
24 months
1 to 30°C
Safety lancets, alcohol swabs,capillary tube,
chase buffer
Abbott Diagnostics Korea Inc
WHO PQ

*
(former Standard Diagnostics)
25 Giheung-gu,Yongin-si, Korea Discrimination If whole blood: lancets,
03FK16 Serum/Plasma/ 24 months alcohol swabs.
Bioline HIV-1/2 3.0 99.80% 99.90% between HIV1 and
Whole Blood 1 to 30°C If 03FK10: lancets, capillary
03FK10 * 30
HIV-2 antibodies pipettes, alcohol swabs.

29011-W20 20
Discrimination
Abbott Rapid Diagnostics Jena Serum/Plasma/ 24 months
Panbio HIV Verification Test 100% 99.70% between HIV 1/2 WHO PQ
GmbH, Germany Whole Blood 2 to 30°C
antibodies
sterile single-use lancets, alcohol
29011AW20 20 swabs,capillary tube

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV Simple Assay 2/49
 HIV Simple assays/Rapid Diagnostic Tests (RDTs)
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark indicates that product is WHO prequalified
Anticipated
Manufacturer Shelf life
Number of Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte Specimen Type (months)/ Comments
tests per kit WHO or GHTF countries
number Storage
temperature

WJ-1810 *
WJ-1810E *
WJ-1810EL * 10T/kit

WJ-18S10 *
WJ-18S10E *
Rapid Test for Antibody to
WJ-18S10EL * HumanImmunodeficiency Virus (HIV) 100% 98.48%
BeijingWantai Biological
Pharmacy Enterprise Co.
HIV 1/2 antibodies Serum/ Plasma/ 18 months
combined detection Whole Blood 2 to 30 °C
For accessories see IFU WHO PQ
(Colloidal Gold Device)

WJ-1850 *
WJ-1850E *
WJ-1850EL * 50T/kit

WJ-18S50 *
WJ-18S50E *
WJ-18S50EL *

*
24 T/kit; 24
24 T/kit with support
90-1010
materials;
If 90-1010: lancets,

90-1013 * 24 alcohol swabs, precision

pipette plus tips.

*
48 T/kit;
48 48 T/kit with
90-1021
BioLytical Laboratories, HIV 1/2 antibodies Serum/Plasma/ 15 months support materials
INSTI HIV-1/HIV-2 Antibody Test Kit 100% 99.70% WHO PQ
Richmond, Canada combined detection Whole Blood 15 to 30 °C If 90-1021: lancets,

90-1022 * 48 alcohol swabs, precision

pipette plus tips.

90-1038 * 48 support material: only pipettes

90-1064 * 48 Support material: none

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV Simple Assay 3/49
 HIV Simple assays/Rapid Diagnostic Tests (RDTs)
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark indicates that product is WHO prequalified
Anticipated
Manufacturer Shelf life
Number of Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte Specimen Type (months)/ Comments
tests per kit WHO or GHTF countries
number Storage
temperature

72330 * 50
with support materials:
Bio-Rad Laboratories, Marnes Serum/Plasma/ diluent and disposable pipettes
72327 * 25 La Coquette France HIV 1/2 antibodies Venous and 18 months
Genie Fast HIV 1/2 100% 99.00% WHO PQ
and (group M and O) Capillary Whole 2 to 30°C
Steenvoorde, France Blood with support materials:
72347 * 25 diluent, disposable pipette, microsafes, lancets,
alcohol swabs

Serum/Plasma/
Venous whole
blood/
Biosynex SA, HIV 1/2 antibodies 24 months
857318 EXACTO© PRO TEST HIV 10 99.9% 99.9% Fingerstick GHTF (CE mark)
Strasbourg, France combined detection 2 to 30°C
Whole
Blood/Oral
Fluid

99.8% HIV-1 Lancet, sterile gauze, antiseptic wipes

(fingerstick whole Biohazard disposal container
Serum/Plasma/ For venipuncture whole blood collection and
blood) 99.9% HIV-1
Venous whole serum/plasma specimens:
(venous whole
blood/ Venipuncture apparatus and blood collection
65-9506-0 * DPP HIV 1/2 Assay 20
blood, serum, 99.9% (serum/plasma,
plasma) 98.9% HIV- whole blood, oral fluid)
Chembio Diagnostic
Systems,Medford, USA
HIV 1/2 antibodies
combined detection
Fingerstick
Whole
24 months
2 to 30°C
tubes
Precision pipette capable of delivering 5µL of
WHO PQ
1 (oral fluid) sample (with disposable tips) may be used in
Blood/Oral
100% HIV-2 lieu of the disposable 5µL sample loop supplied
Fluid
(serum/plasma, with the kit (for other than fingerstick whole
blood, oral fluid) blood specimens)

If whole blood: lancets,

alcohol swabs.
HIV303 * HIV 1/2 STAT-PAK Dipstick 30 100% 99.70%
Chembio Diagnostic Systems,
Medford, USA
HIV 1/2 antibodies Serum/Plasma/
combined detection Whole Blood
24 months
8 to 30°C
If alternate procedure: must
order sample tubes and tube
WHO PQ

rack.

WHO PQ
If whole blood: lancets,
https://extranet.who.int/pqweb/sites/def
HIV101 * HIV 1/2 STAT-PAK™ 20 99.30% 100%
Chembio Diagnostic Systems,
Medford, USA
HIV 1/2 antibodies Serum/Plasma/
combined detection Whole Blood
24 months
8 to 30°C
alcohol swabs.
HIV Test Kit Controls (HIV104)
available.
ault/files/PQDx_0007-006-00_HIV_1-
2_STAT-PAK_v2.0.pdf
GHTF (FDA, PMA)

Lancet, sterile gauze, antiseptic wipes

Biohazard disposal container
99.8% Serum/Plasma/ For venipuncture whole blood collection and
WHO PQ
HIV201 * SURE CHECK® HIV 1/2 ASSAY 25
(serum/plasma)
100% HIV-2
(serum/plasma)
99.9% (serum/plasma)
Chembio Diagnostic
Systems,Medford, USA
HIV 1/2 antibodies Venous and
combined detection Capillary Whole
Blood
24 months
8 to 30°C
serum/plasma specimens:
Venipuncture apparatus and blood collection
tubes GHTF (FDA, PMA)
Precision pipette capable of delivering 2.5µL of
specimen with disposable tips

Whole Blood,
"DIAQUICK" Dialab GmbH, HIV 1/2 antibodies 24 months
Z09742CE 30 100% 100% Serum or GHTF (CE mark)
HIV 1&2 Ab Cassette Austria combined detection 2 to 30°C
Plasma

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV Simple Assay 4/49
 HIV Simple assays/Rapid Diagnostic Tests (RDTs)
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark indicates that product is WHO prequalified
Anticipated
Manufacturer Shelf life
Number of Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte Specimen Type (months)/ Comments
tests per kit WHO or GHTF countries
number Storage
temperature

"DIAQUICK" Dialab GmbH, HIV 1/2 antibodies Serum or 24 months

H18100 25 100% 100% GHTF (CE mark)
HIV Plus Austria combined detection Plasma 2 to 30°C

Whole Blood,
"DIAQUICK" Dialab GmbH, HIV 1/2 antibodies 25 months
H18101 25 100% 100% Serum or GHTF (CE mark)
HIV Plus WB Austria combined detection 2 to 30°C
Plasma

Serum/Plasma/ 24 months Buffer solution included: 1 bottle × 5mL/bottle

W006-C4P2 25 Accessories: not included
Whole Blood 2 to 30 °C

Serum/Plasma/ 24 months Buffer solution included: 1 bottle × 5mL/bottle

W006-P0045 25 Accessories: see IFU
Whole Blood 2 to 30 °C

Serum/Plasma/ 24 months Buffer solution included: 1 bottle × 5mL/bottle

W006-P0046 25 Accessories: see IFU
Whole Blood 2 to 30 °C

Serum/Plasma/ 24 months Buffer solution included: 1 bottle × 5mL/bottle

W006-P0047 25 Accessories: see IFU
Whole Blood 2 to 30 °C

Serum/Plasma/ 24 months Buffer solution included: 1 bottle × 5mL/bottle

W006-P0048 25 Guangzhou Wondfo Biotech Co.
Whole Blood 2 to 30 °C Accessories: see IFU
Wondfo® One Step HIV1/2 Whole Ltd, 8 Lizhishan Road, Science HIV 1/2 antibodies
100.0% 100.00% WHO PQ
Blood/Serum/Plasma Test City, Luogang District, combined detection Buffer solution included: 2 bottles ×
Serum/Plasma/ 24 months
W006-C4P2-F 40 Guangzhou, 510663, P.R. China 5mL/bottle
Whole Blood 2 to 30 °C Accessories: not included
Buffer solution included: 2 bottles ×
Serum/Plasma/ 24 months
W006-P0049 40 5mL/bottle
Whole Blood 2 to 30 °C Accessories: see IFU
Buffer solution included: 2 bottles ×
Serum/Plasma/ 24 months
W006-P0050 40 5mL/bottle
Whole Blood 2 to 30 °C Accessories: see IFU
Buffer solution included: 2 bottles ×
Serum/Plasma/ 24 months
W006-P0051 40 5mL/bottle
Whole Blood 2 to 30 °C Accessories: see IFU
Buffer solution included: 2 bottles ×
Serum/Plasma/ 24 months
W006-P0052 40 5mL/bottle
Whole Blood 2 to 30 °C Accessories: see IFU
Human Gesellschaft für
Whole blood,
Biochemica und Diagnostica HIV 1/2 antibodies
57002P Hexagon HIV 40 100% 99.90% serum or 2 to 8°C GHTF (CE mark)
mbH combined detection
plasma
Germany

Human Gesellschaft für

Whole blood,
Biochemica und Diagnostica HIV 1/2 antibodies
57004P Hexagon HIV 100 100% 99.90% serum or 2 to 8°C GHTF (CE mark)
mbH combined detection
plasma
Germany

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV Simple Assay 5/49
 HIV Simple assays/Rapid Diagnostic Tests (RDTs)
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark indicates that product is WHO prequalified
Anticipated
Manufacturer Shelf life
Number of Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte Specimen Type (months)/ Comments
tests per kit WHO or GHTF countries
number Storage
temperature

InTec PRODUCTS, INC.

Accessories: plastic dropper (pippette), sample
ITPW02153- 332 Xinguang Road, Xinyang HIV 1/2 antibodies Serum/Plasma/ 24 months
diluent (2mLx4 bottles), sterile safety lancets,
ONE STEP Anti-HIV(1&2 ) Test 40 100.0% 100.00%
TC40 Ind. Area, Haicang, Xiamen, combined detection Whole Blood 2 to 30 °C alcohol swabs
361022, P.R. China

WHO PQ
ITPW02152- Serum/Plasma/ 24 months Accessories: plastic dropper (pippette), sample
40 InTec PRODUCTS, INC.
TC40 Whole Blood 2 to 30 °C diluent (2mLx4 bottles)
332 Xinguang Road, Xinyang HIV 1/2 antibodies
ONE STEP Anti-HIV(1&2 ) Test 100.0% 100.00%
Ind. Area, Haicang, Xiamen, combined detection
ITPW02152- 361022, P.R. China Serum/Plasma/ 24 months Accessories: plastic dropper (pippette), sample
25 diluent (2mLx3 bottles)
TC25 Whole Blood 2 to 30 °C

InTec PRODUCTS, INC.

332 Xinguang Road, Xinyang HIV 1/2 antibodies Serum/Plasma/ 24 months
ITP02121-TC40 ONE STEP Anti-HIV(1&2 ) Test 40 99.8% 99.23% Accessories: plastic dropper (pippette) GHTF (CE mark)
Ind. Area, Haicang, Xiamen, combined detection Whole Blood 2 to 30 °C
361022, P.R. China

InTec PRODUCTS, INC. Serum/Plasma/ 24 months Accessories: plastic dropper (pippette), safety
ITP02122-TC40 40 lancets, alcohol swabs GHTF (CE mark)
332 Xinguang Road, Xinyang HIV 1/2 antibodies Whole Blood 2 to 30 °C
ONE STEP Anti-HIV(1&2 ) Test 99.8% 99.23%
Ind. Area, Haicang, Xiamen, combined detection
361022, P.R. China Serum/Plasma/ 24 months Accessories: plastic dropper (pippette), safety
ITP02122-TC10 10 lancets, alcohol swabs
GHTF (CE mark)
Whole Blood 2 to 30 °C

HVWRPD-01 30
Capillary Tubes,
Meril Diagnostics Pvt. Ltd., HIV 1/2 antibodies Serum/Plasma/ 24 months
MERISCREEN HIV 1-2 WB 100% 100.00% Alcohol swabs and GHTF (CE mark)
Vapi+F56, India combined detection Whole Blood 2 to 30 °C lancets
HVWRPD-02 40

Detect antibodies
specific to HIV-1
gp120, HIV-1 gp41,
HIV-1 p24 (also react Additional devices which are necessary for
performing the test are:
with HIV-2) and HIV-
MP Biomedicals Asia Pacific Serum/Plasma/ 24 months - lancets (skin prick to gain the patients sample)
43030-020 Multisure HIV Rapid Test 20 100% 99.12% 2 gp36 antigens in - alcohol swaps (disinfection of the pricking
GHTF (CE mark)
Singapore Whole Blood 2 to 28 °C
human serum, position)
plasma, finger  timer
pricked whole blood
or whole blood with
anti-coagulants

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV Simple Assay 6/49
 HIV Simple assays/Rapid Diagnostic Tests (RDTs)
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark indicates that product is WHO prequalified
Anticipated
Manufacturer Shelf life
Number of Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte Specimen Type (months)/ Comments
tests per kit WHO or GHTF countries
number Storage
temperature

5X4-0010 * 100
If whole blood: lancets,
alcohol swabs, additional

5X4-0012 * 500
Serum/Plasma/
specimen loops (004-001).

OraSure Technologies
5X4-0014 * OraQuick® HIV-1/2 - Rapid Antibody Test 100 100% 99.20% Bethlehem, USA
(manufactured in Thailand)
HIV 1/2 antibodies
combined detection
Whole
Blood/Oral
30 months
2 to 30°C
If whole blood: lancets,
alcohol swabs, additional
WHO PQ
Fluid specimen loops (004-001).
Consult WHO PQ Public Report for country
5X4-0015 * 500 specific labelling.

5X4-0062 * 100
Thailand-specific product code /
No specimen collection loops

1001-0079 25 Serum/Plasma/
If whole blood: lancets,
OraQuick® ADVANCE Rapid HIV-1/2 OraSure Technologies HIV 1/2 antibodies Whole 30 months
99.3%* 99.8%* alcohol swabs, additional GHTF (FDA, PMA)
Antibody Test Bethlehem, USA combined detection Blood/Oral 2 to 30°C specimen loops (004-001).
1001-0078 100 Fluid*

Discrimination
between
Premier Medical Corporation, Serum/Plasma/ 24 months If whole blood: lancets,
I05FRC25CE First Response® HIV 1-2-0 Card Test 25 100% 99.39% HIV-1 and alcohol swabs.
GHTF (CE mark)
Nani Daman, India Whole Blood 4 to 30°C
HIV-2
Antibodies

Discrimination
between
Premier Medical Corporation, Serum/Plasma/ 24 months If whole blood: lancets,
I05FRC30CE First Response® HIV 1-2-0 Card Test 30 100% 99.39% HIV-1 and alcohol swabs.
GHTF (CE mark)
Nani Daman, India Whole Blood 4 to 30°C
HIV-2
Antibodies

Discrimination
Premier Medical Corporation
between
PI05FRC05 * First Response® HIV 1-2-0 Card Test (version
2.0)
5 100% 100.00%
Private Limited, A1-302, GIDC,
Sarigam - 396 155, District
HIV-1 and
HIV-2
Serum/Plasma/
Whole Blood
24 months
4 to 30°C
If whole blood: lancets,
alcohol swabs.
WHO PQ
Valsad, Gujarat, INDIA
Antibodies

Discrimination
Premier Medical Corporation
between
First Response® HIV 1-2-0 Card Test (version Private Limited, A1-302, GIDC, Serum/Plasma/ 24 months If whole blood: lancets,
PI05FRC05CE 5 100% 100.00% HIV-1 and alcohol swabs.
GHTF (CE mark)
2.0) Sarigam - 396 155, District Whole Blood 4 to 30°C
HIV-2
Valsad, Gujarat, INDIA
Antibodies

Discrimination
Premier Medical Corporation
between
PI05FRC10 * First Response® HIV 1-2-0 Card Test (version
2.0)
10 100% 100.00%
Private Limited, A1-302, GIDC,
Sarigam - 396 155, District
HIV-1 and
HIV-2
Serum/Plasma/
Whole Blood
24 months
4 to 30°C
If whole blood: lancets,
alcohol swabs.
WHO PQ
Valsad, Gujarat, INDIA
Antibodies

Discrimination
Premier Medical Corporation
between
First Response® HIV 1-2-0 Card Test (version Private Limited, A1-302, GIDC, Serum/Plasma/ 24 months If whole blood: lancets,
PI05FRC10CE 10 100% 100.00% HIV-1 and alcohol swabs.
GHTF (CE mark)
2.0) Sarigam - 396 155, District Whole Blood 4 to 30°C
HIV-2
Valsad, Gujarat, INDIA
Antibodies

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV Simple Assay 7/49
 HIV Simple assays/Rapid Diagnostic Tests (RDTs)
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark indicates that product is WHO prequalified
Anticipated
Manufacturer Shelf life
Number of Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte Specimen Type (months)/ Comments
tests per kit WHO or GHTF countries
number Storage
temperature

Discrimination
Premier Medical Corporation
between
PI05FRC25 * First Response® HIV 1-2-0 Card Test (version
2.0)
25 100% 100.00%
Private Limited, A1-302, GIDC,
Sarigam - 396 155, District
HIV-1 and
HIV-2
Serum/Plasma/
Whole Blood
24 months
4 to 30°C
If whole blood: lancets,
alcohol swabs.
WHO PQ
Valsad, Gujarat, INDIA
Antibodies

Discrimination
Premier Medical Corporation
between
First Response® HIV 1-2-0 Card Test (version Private Limited, A1-302, GIDC, Serum/Plasma/ 24 months If whole blood: lancets,
PI05FRC25CE 25 100% 100.00% HIV-1 and alcohol swabs.
GHTF (CE mark)
2.0) Sarigam - 396 155, District Whole Blood 4 to 30°C
HIV-2
Valsad, Gujarat, INDIA
Antibodies

Discrimination
Premier Medical Corporation
between
PI05FRC30 * First Response® HIV 1-2-0 Card Test (version
2.0)
30 100% 100.00%
Private Limited, A1-302, GIDC,
Sarigam - 396 155, District
HIV-1 and
HIV-2
Serum/Plasma/
Whole Blood
24 months
4 to 30°C
If whole blood: lancets,
alcohol swabs.
WHO PQ
Valsad, Gujarat, INDIA
Antibodies

Discrimination
Premier Medical Corporation
between
First Response® HIV 1-2-0 Card Test (version Private Limited, A1-302, GIDC, Serum/Plasma/ 24 months If whole blood: lancets,
PI05FRC30CE 30 100% 100.00% HIV-1 and alcohol swabs.
GHTF (CE mark)
2.0) Sarigam - 396 155, District Whole Blood 4 to 30°C
HIV-2
Valsad, Gujarat, INDIA
Antibodies

Discrimination
Premier Medical Corporation
between
PI05FRC50 * First Response® HIV 1-2-0 Card Test (version
2.0)
30 100% 100.00%
Private Limited, A1-302, GIDC,
Sarigam - 396 155, District
HIV-1 and
HIV-2
Serum/Plasma/
Whole Blood
24 months
4 to 30°C
If whole blood: lancets,
alcohol swabs.
WHO PQ
Valsad, Gujarat, INDIA
Antibodies
Discrimination
Premier Medical Corporation
between
PI05FRC60 * First Response® HIV 1-2-0 Card Test (version
2.0)
60 100% 100.00%
Private Limited, A1-302, GIDC,
Sarigam - 396 155, District
HIV-1 and
HIV-2
Serum/Plasma/
Whole Blood
24 months
4 to 30°C
If whole blood: lancets,
alcohol swabs. WHO PQ
Valsad, Gujarat, INDIA
Antibodies
Discrimination
Premier Medical Corporation
between
PI05FRC100 * First Response® HIV 1-2-0 Card Test (version
2.0)
100 100% 100.00%
Private Limited, A1-302, GIDC,
Sarigam - 396 155, District
HIV-1 and
HIV-2
Serum/Plasma/
Whole Blood
24 months
4 to 30°C
If whole blood: lancets,
alcohol swabs.
WHO PQ
Valsad, Gujarat, INDIA
Antibodies

09HIV30D * 25 see WHO Public Report for consumables

SD Biosensor Inc Discrimination
(16, Deogyeong-daero, between
24 months
STANDARD Q HIV 1/2 Ab 3-Line Test 100.00% 99.30% 1556 beon-gil, Yeongtong-gu, HIV-1 and Serum/Plasma/ WHO PQ
2 to 40°C
Suwon-si, Gyeonggi-do 16690 HIV-2 Whole Blood
Republic of Korea) antibodies

09HIV30DM * 25 see WHO Public Report for consumables

R-401-50-C-2, If whole blood: lancets,

KH-R-02, alcohol swabs, chase buffer, EDTA capillary
Diagnostic kit for HIV (1+2) antibody (colloidal Shanghai Kehua Bio- HIV 1/2 antibodies Serum/Plasma/ 24 months tubes.
A-GOLD-01, 50 100% 100.00% WHO PQ
gold) V2 engineering Co., Ltd combined detection Whole Blood 4 to 30°C If serum/plasma: requires, blood collection
R-401-50-C-3 * tubes
precision pipette plus tips.

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV Simple Assay 8/49
 HIV Simple assays/Rapid Diagnostic Tests (RDTs)
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark indicates that product is WHO prequalified
Anticipated
Manufacturer Shelf life
Number of Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte Specimen Type (months)/ Comments
tests per kit WHO or GHTF countries
number Storage
temperature

Whole Blood,
Turk Lab HIV 1/2 antibodies
THIV02 Toyo Anti-HIV 1/2 100% 100% Serum or 4 - 30°C GHTF (CE mark)
Turkey combined detection
Plasma

Trinity Biotech Manufacturing Whole Blood,

HIV 1/2 antibodies 24 months
5551100 TrinScreen HIV 100 100% 100% Ltd, Serum or WHO PQ
combined detection 2 - 30°C
Bray, Ireland Plasma

1206502
+ Accessories:
1206502N+ 20 1 vial Wash Reagent (2

*
ml) and 20
1206502E Trinity Biotech Manufacturing Disposable Pipettes
HIV 1/2 antibodies Serum/Plasma/ 20 months
Uni-Gold HIV 99.80% 99.90% Ltd,
combined detection Whole Blood 2 to 27°C
1206502-100 Bray, Ireland
Accessories:
1206502N- 5 vials Wash Reagent (2
100
* ml) and 100 WHO PQ
100 Disposable Pipettes

1206502-C
Accessories:lancets, alcohol swabs.
Trinity Biotech Manufacturing
HIV 1/2 antibodies Serum/Plasma/ 20 months 1 vial Wash Reagent (2
Uni-Gold HIV Complete 20 99.80% 99.90% Ltd,
1206502E-C * Bray, Ireland
combined detection Whole Blood 2 to 27°C ml) and 20
Disposable Pipettes

N/A- NOT APPLICABLE

Disclaimer:The Global Fund does not endorse or warrant the fitness of any product on the List for a particular purpose. In addition, the Global Fund assumes no responsibility for any misstatement or omission from the list and directs Principal Recipients of Global Fund grants to conduct their own independent confirmation that the information on a given product on the list is accurate before relying on it to
make a purchase order for that product, and to ensure that any purchase is in compliance with all the requirements of the Global Fund’s quality assurance policy. The Global Fund does not warrant or represent that the products listed have obtained regulatory approval for use in any particular country of the world, or that their use is otherwise in accordance with the national laws and regulations of any country,
including, but not limited to, intellectual property laws. The Global Fund disclaims any and all liability and responsibility for any injury, death, damage or loss of any kind whatsoever that may arise as a result of, or in connection with the procurement, distribution and use of any product included in the list.

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV Simple Assay 9/49
 Version 48

29 Mars 2023

List of HIV Diagnostic test kits and equipments classified according to the Global Fund Quality Assurance Policy

HIV Self Tests / Rapid Diagnostic Tests (RDTs)

(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark indicates that product is WHO prequalified

Anticipated
Manufacturer Shelf life
Number of Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte Specimen Type (months)/ Comments
tests per kit WHO or GHTF countries
number Storage
temperature

WHO PQ
https://extranet.who.int/pqweb/sites/defa
29012-W01 * CHECKNOW© HIV SELFTEST 1 99.50% 98.50%
Abbott Rapid Diagnostics Jena
GmbH
HIV 1/2 antibodies
combined detection
Whole Blood
24 Months
2 to 30°C
(former ERPD as RISK CATEGORY-2) ult/files/PQDx_0481-032-
00_CheckNOW_HIV-
SelfTest_PR_v2.0.pdf

ARST001-03
ARST001-03-01 WHO PQ
ARST001-03-02 Mylan HIV Self-Test Atomo Diagnostics Pty Ltd, HIV 1/2 antibodies 18 Months https://extranet.who.int/pqweb/sites/defa
1 99.80% 99.80% Whole Blood (former ERPD as RISK CATEGORY-2)
ARST001-03-03 (former Atomo HIV Self-Test) Leichhardt, Australia combined detection 2 to 30°C ult/files/PQDx_0320-090-00_MylanHIV-

*
SelfTest_V3.0.pdf

90-1071 * INSTI® HIV Self Test 1 99.80% 99.50%

BioLytical Laboratories, HIV 1/2 antibodies
Whole Blood
15 Months
WHO PQ
https://www.who.int/diagnostics_laborat
ory/evaluations/pq-
Richmond, Canada combined detection 2 to 30°C list/181130_pqdx_0002_002_01_pqpr_i
nsti_self_test.pdf?ua=1

Products available from

Biosynex SA, HIV 1/2 antibodies 24 Months ERPD as RISK CATEGORY-2 / Non-Objection-
855164 EXACTO© TEST HIV 1 on request on request Whole Blood ERPD until 10th January 2024
Strasbourg, France combined detection 2 to 30°C Letters are required for procurement

Products available from

Biosynex SA, HIV 1/2 antibodies 24 Months ERPD as RISK CATEGORY-2 / Non-Objection-
855169 EXACTO© TEST HIV DUO 2 on request on request Whole Blood ERPD until 10th January 2024
Strasbourg, France combined detection 2 to 30°C Letters are required for procurement

WHO PQ
https://www.who.int/diagnostics_laborat
60-9508-0 * SURE CHECK HIV SELF-TEST 1 97.00% 100.00%
Chembio Diagnostic
Systems,Medford, USA
HIV 1/2 antibodies
combined detection
Whole Blood
24 Months
8 to 30°C
ory/evaluations/pq-
list/191129_pqdx_0054_006_01_sure_ch
eck_hiv_self_test.pdf?ua=1

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV Self Tests 10/49
 HIV Self Tests / Rapid Diagnostic Tests (RDTs)
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark indicates that product is WHO prequalified

Anticipated
Manufacturer Shelf life
Number of Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte Specimen Type (months)/ Comments
tests per kit WHO or GHTF countries
number Storage
temperature

W006P0058 * 1

W006P0059 * Wondfo HIV Self-Test 20 95.80% 99.60%

Guangzhou Wondfo Biotech
Co., Ltd
HIV 1/2 antibodies
combined detection
Whole Blood
24 Months
2 to 30°C
WHO PQ

W006P0060 * 100

5X4-0004.###

* 1

5X4-1000.### Community Version

* 50 Individual Test pouches are labeled 5X4-

0004.###

5X4-1001.###

* 250

5X4-2001.### * 110
OraSure Technologies Inc,
Pharmacy Version
(placed in individual cartons)
WHO PQ
HIV 1/2 antibodies 30 Months https://extranet.who.int/pqweb/sites/defa
OraQuick HIV Self-Test 99.02% 100.00% Bethlehem, USA Oral fluid ult/files/PQDx_0159-055-
combined detection 2 to 30°C
5X4- (manufactured in Thailand) 01_OraQuickHIVSelfTest_v7.0.pdf

2001U.### * 1

Community Version
5X4-7000.050 * 50 Individual Test boxes are labeled 5X4-
2001U.###

5X4-7000.250 * 250

5X4-7000.200 * 200
Pharmacy Version
(placed in individual cartons)

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV Self Tests 11/49
 HIV Self Tests / Rapid Diagnostic Tests (RDTs)
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark indicates that product is WHO prequalified

Anticipated
Manufacturer Shelf life
Number of Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte Specimen Type (months)/ Comments
tests per kit WHO or GHTF countries
number Storage
temperature

N/A- NOT APPLICABLE

Disclaimer:The Global Fund does not endorse or warrant the fitness of any product on the List for a particular purpose. In addition, the Global Fund assumes no responsibility for any misstatement or omission from the list and directs Principal Recipients of Global Fund grants to conduct their own independent confirmation that the information on a given product on the list is accurate before relying on it to
make a purchase order for that product, and to ensure that any purchase is in compliance with all the requirements of the Global Fund’s quality assurance policy. The Global Fund does not warrant or represent that the products listed have obtained regulatory approval for use in any particular country of the world, or that their use is otherwise in accordance with the national laws and regulations of any
country, including, but not limited to, intellectual property laws. The Global Fund disclaims any and all liability and responsibility for any injury, death, damage or loss of any kind whatsoever that may arise as a result of, or in connection with the procurement, distribution and use of any product included in the list.

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV Self Tests 12/49
 Version 48

29 Mars 2023

List of HIV Diagnostic test kits and equipments classified according to the Global Fund Quality Assurance Policy

HIV Enzyme Immunoassays (EIAs) (including chemiluminescence immunoassays [CLIA])

(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Anticipated Shelf
Manufacturer life
Number of tests Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte (months)/ Comments
per kit WHO or GHTF countries
number Storage
temperature

Serum or plasma specimens;

100 Note: The ARCHITECT HIV Ag/Ab Combo assay is not
Abbott Laboratories, HIV-1 p24 antigen, intended for use in screening blood or plasma donors. The
effectiveness of ARCHITECT HIV Ag/Ab Combo for use in
ARCHITECT HIV Ag/Ab Combo Reagent Abbott Diagnostics Division, antibodies to HIV-1 (group M
4J2732 100% 99.77% screening blood or plasma donors has not been established. GHTF (US FDA PMA)
Kit (CLIA) 100 Abbott park Road and group O), and antibodies 2 to 8°C However, this assay can be used as a blood donor screening
Abbott Park, IL, USA to HIV-2 assay in urgent situations where traditional licensed blood
donor screening tests are unavailable or their use is
500
impractical.

100%
99.96% (blood donor Abbott Diagnostics, Wiesbaden, HIV1/2 antibodies combined 3 months Serum and plasma specimen
7G 46 Abbott PRISM HIV Ag/Ab Combo Assay up to 5000 (but with 19% Activator concentrate, Activator diluent GHTF (TGA)
specimens) Germany and HIV1-p24 antigen 2 to 8°C
"void" results)

WI-4396 * AiD anti-HIV 1+2 ELISA 96 100.00% 99.92%

Beijing Wantai Biological Pharmacy HIV-1/2 antibodies and HIV-
Enterprise Co., Ltd. 1 p24 antigen
2 to 8°C Serum or plasma WHO PQ
https://www.who.int/diagnostics_laboratory/eval
uations/160218_final_public_report_pqdx_0006
_005_00_aid_anti_hiv_1_2_elisa.pdf?ua=1

WI-43480 * AiD anti-HIV 1+2 ELISA 480 100.00% 99.92%

Beijing Wantai Biological Pharmacy HIV-1/2 antibodies and HIV-
Enterprise Co., Ltd. 1 p24 antigen
2 to 8°C Serum or plasma GHTF (CE mark)

790000 96 100.00% 99.60%

apDia bvba, Raadsherenstraat 3, B-

HIV-1/2 antibodies and HIV- 15 months
790001 apDia HIV Ab & Ag Elisa 196 100.00% 99.60% 2300 Turnhout, Serum or plasma GHTF (CE mark)
1 p24 antigen 2 to 8°C
Belgium

790005 480 100.00% 99.60%

880007 96
Axiom GmbH
Am Jahnplatz 5 15 months
HIV 1+2 Ab Elisa 100.00% 99.90% HIV 1/2 antibodies combined Human serum and plasma specimens GHTF (CE mark)
68642 Bürstadt 2 to 8°C
Germany
880007s 480

bioMérieux SA
HIV-1/2 antibodies and HIV- Serum or plasma
259851 Vironostika HIV Ag/Ab 192 100.00% 99.50% 69280 - Marcy-l’Etoile / France 2 to 8°C GHTF (CE mark)
1 p24 antigen
RCS LYON 673 620 399

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV-EIA 13/49
 HIV Enzyme Immunoassays (EIAs) (including chemiluminescence immunoassays [CLIA])
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Anticipated Shelf
Manufacturer life
Number of tests Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte (months)/ Comments
per kit WHO or GHTF countries
number Storage
temperature

bioMérieux SA
HIV-1/2 antibodies and HIV- Serum or plasma
259852 Vironostika HIV Ag/Ab 576 100.00% 99.50% 69280 - Marcy-l’Etoile / France 2 to 8°C GHTF (CE mark)
1 p24 antigen
RCS LYON 673 620 399

Bio-Rad Laboratories, Marnes La

72278 96 Serum and plasma specimen
Coquette, France
HIV 1/2 antibodies combined 18 months Precision pipette (and tips), EIA plate washer, EIA plate
GenScreen™ HIV 1/2 Version 2 100% 99.80% and incubator, EIA plate reader, vacuum disposal system,
GHTF (CE mark, TGA)
or discrimination 2 to 8°C
Bio-Rad Laboratories, measuring cylinders, reagent troughs
72279 480
Steenvoorde, France

72386 * GenScreen™ ULTRA HIV Ag-Ab

96
100% 99.20%
Bio-Rad Laboratories, Steenvoorde, HIV 1/2 antibodies combined 18 months
Not suitable for whole blood
Requires EIA incubator,
washer, reader, precision
WHO PQ
https://extranet.who.int/pqweb/sites/default/file
France and HIV1- p24 antigen 2 to 8°C
*
s/PQDx_0096-031-00_GenscreenULTRA-
pipette plus tips, deionised HIV_Ag-Ab_v2.0.pdf
480 water.
72388

Bio-Rad
months Human Serum, Plasma and Cell Culture Supernatant
71120 Genscreen™ HIV-1 Ag Assay 192 99.95% 3, boulevard Raymond Poincaré HIV1- p24 antigen GHTF (CE mark)
2 to 8°C
92430 Marnes-la-Coquette - France

Serum and plasma specimen

26217 192 For product code 26218 (960 tests): wash solution (25261)
and stopping solution (25260) must be ordered separately.
100% (manual 99.87% (manual Biohazard disposal container
For venipuncture serum/plasma specimens:
method) method) Bio-Rad Laboratories, Steenvoorde, HIV-1 p24 antigen and 18 months
GS HIV Combo Ag/Ab EIA Venipuncture apparatus and blood collection tubes GHTF (FDA, PMA)
100% (Evolis 99.97% (Evolis France HIV1/2 antibodies 2 to 8°C Precision pipette (and tips), EIA plate washer, EIA plate
system) system) incubator, EIA plate reader, vacuum disposal system,
measuring cylinders, reagent troughs, deionized or distilled
26218 960 water. The GS HIV Combo Ag/Ab EIA is approved for use
with the Bio-Rad EVOLIS™ Automated Microplate System.

IVCOMB.CE 192 100.00% 99.50%

IVCOMB.CE 96 96 100.00% 99.50%

DIA.PRO Diagnostic Bioprobes S.r.l. HIV-1/2 antibodies and HIV- 15 months
HIV Ab & Ag Elisa Serum or plasma GHTF (CE mark)
Italy 1 p24 antigen 2 to 8°C
IVCOMB.CE 480 480 100.00% 99.50%

IVCOMB.CE 960 960 100.00% 99.50%

Z01375 1x96 100.00% 99.92%

Dialab GmbH, 15 months
HIV 1&2 Ab, cut-off HIV-1/2 antibodies Serum or plasma GHTF (CE mark)
Austria 2-8°C
Z03502 5x96 100.00% 99.92%

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV-EIA 14/49
 HIV Enzyme Immunoassays (EIAs) (including chemiluminescence immunoassays [CLIA])
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Anticipated Shelf
Manufacturer life
Number of tests Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte (months)/ Comments
per kit WHO or GHTF countries
number Storage
temperature

Z04380 1x96 100.00% 99.96%

HIV 1&2 Ag/Ab, Dialab GmbH, HIV-1/2 antibodies and HIV- 15 months
Serum or plasma GHTF (CE mark)
Double Ag&Ab Sandwich Principle Austria 1 p24 antigen 2-8°C
Z13382 5x96 100.00% 99.96%

In EDTA/Citrate Plasma specimen

1. Stop Solution (0.5Mto 2MSulphuric Acid).
9E25-01 96 2. Freshly distilled or high quality deionized water
3. Micropipettes and Multichannel micropipettes of
appropriate volume.
4. Incubator capable of maintaining the temperature limits
defined in the assay protocol.
5. Moulded Heating Block (Code 5F09 02). For use in
laboratory incubators.
HIV 1/2 Antibodies (IgG, 12 months 6. Instrumentation
Murex HIV - 1.2.0 100% 99.91% DiaSorin, Dartford, United Kingdon a) Automated microplate strip washer.
GHTF (CE mark, TGA)
IgM, IgA) 2 to 8°C
b) Microplate reader.
or
c) Fully automated microplate processor.
All instruments must be validated before use.
7. Disposable Reagent Troughs. (Code 5F24 01).
9E25-02 480 8. Sodium hypochlorite for decontamination (Refer to Health
and Safety Information).
9. Sodium hydroxide solution (0.1M) (for instrument
decontamination)

Serum and plasma specimen

7G79-09 * 96 1. Stop Solution (0.5M to 2M Sulphuric Acid).

2. Freshly distilled or high quality deionised water
3. Micropipettes and Multichannel micropipettes of
appropriate volume.
4. Incubator capable of maintaining the temperature limits
defined in the assay protocol. WHO PQ
5. Moulded Heating Block (Code 5F09-02). https://www.who.int/diagnost
Combined detection of HIV-1 6. Instrumentation ics_laboratory/evaluations/1
12 months
Murex HIV Ag/Ab Combination 100% 99.78% DiaSorin Dartford, United Kingdon p24 and HIV 1/2 Antibodies a) Automated microplate stripwasher. 50330_final_report_murex_h
2 to 8°C b) Microplate reader.
(IgG, IgM, IgA) iv_ag_ab.pdf?ua=1
or
c) Fully automated microplate processor. GHTF (CE mark, TGA)
All instruments must be validated before use.

*
7. Disposable Reagent Troughs. (Code 5F24-01).
480 8. Sodium hypochlorite for decontamination. (Refer to Health
7G79-11
and Safety Information)
9. Sodium hydroxide solution (0.1M). (Refer to Analytical
Precautions).

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV-EIA 15/49
 HIV Enzyme Immunoassays (EIAs) (including chemiluminescence immunoassays [CLIA])
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Anticipated Shelf
Manufacturer life
Number of tests Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte (months)/ Comments
per kit WHO or GHTF countries
number Storage
temperature

HIV-1 p24 antigen and HIV-

DiaSorin S.p.A., Saluggia (Vercelli), 12 months serum or plasma specimens
310260 LIAISON XL 200 100% 99.50% 1/2 GHTF (CE mark, TGA)
Italy 2 to 8°C
antibodies

80563 96 p24 core antigens of the

human immunodeficiency
Fujirebio Europe N.V., Ghent, human serum, plasma, or cell culture
INNOTEST HIV Ag mAb 100% 100.00% virus type 1 supernatant
GHTF (CE mark)
Belgium
(HIV-1), HIV-1 group O, and
80564 480 type 2 (HIV-2)

serum or plasma specimens;

Note: The VITROS HIV Combo test is not intended for use in
shelf life on
VITROS Immunodiagnostic Products Ortho-Clinical Diagnostics, Bridgend, Combined detection of HIV-1 screening blood or plasma donors. However, this assay can be
684 2781 100 100% 98.82% request used as a blood donor screening assay in urgent situations GHTF (CE, PMA)
HIV Combo Reagent Pack United Kingdom p24 and HIV 1/2 Antibodies
2 to 8°C where traditional licensed blood donor screening tests are
unavailable or their use is impractical.

(05 390 095

190) being
100
replaced by
08 924 163 190

Serum and plasma specimen

99.82% (blood donor cobas e 411 analyzer, cobas e 601 / 602 modules
specimens) 15 months
Roche Diagnostics, Mannheim, HIV 1 p24 antigen and
Elecsys HIV Combi PT 100% 99.8% (diagnostic 2 to 8°C Note: Specimen collected from living patients, blood donors, GHTF (CE mark)
Germany HIV1/2 antibodies or individual organ, tissue or cell donors may be used,
specimens) (Do not freeze)
including donor samples obtained while the donor’s heart is
still beating.
(07 914 504 190)
being replaced
200
by
08 924 180 190

Serum and plasma specimen:

cobas e 402 / cobas e 801 analytical units
(07 229 542 190) 99.87% (blood donor
18 months Note: Specimen collected from living patients, blood donors,
being replaced specimens) Roche Diagnostics, Mannheim, HIV 1 p24 antigen and or individual organ, tissue
Elecsys® HIV Duo 300 100% 2 to 8°C GHTF (CE mark)
by 99.92% (diagnostic Germany HIV1/2 antibodies
(Do not freeze) or cell donors may be used, including donor samples obtained
08 836 973 190 specimens) while the donor’s
heart is still beating.

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV-EIA 16/49
 HIV Enzyme Immunoassays (EIAs) (including chemiluminescence immunoassays [CLIA])
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Anticipated Shelf
Manufacturer life
Number of tests Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte (months)/ Comments
per kit WHO or GHTF countries
number Storage
temperature

I-1654/1.2 * 96/1 plate

RPC «Diagnostic Systems», Ltd. WHO PQ

HIV1/2 antibodies combined
I-1652/1.2 * DS-EIA-HIV-AGAB-SCREEN 192/2 plates 100% 99.60% Nizhny Novgorod
Russian Federation
and HIV1-p24 antigen
24 months
2-8 ˚C
Serum or plama specimen https://extranet.who.int/pqweb/sites/default/file
s/PQDx_0106-038-00_DS-EIA-HIV-AGAB-
SCREEN_v4.0.pdf

I-1656/1.2 * 480/5 plates

N/A- NOT APPLICABLE

Disclaimer:The Global Fund does not endorse or warrant the fitness of any product on the List for a particular purpose. In addition, the Global Fund assumes no responsibility for any misstatement or omission from the list and directs Principal Recipients of Global Fund grants to conduct their own independent confirmation that the information on a given product on the list is accurate before relying on it to make a
purchase order for that product, and to ensure that any purchase is in compliance with all the requirements of the Global Fund’s quality assurance policy. The Global Fund does not warrant or represent that the products listed have obtained regulatory approval for use in any particular country of the world, or that their use is otherwise in accordance with the national laws and regulations of any country, including, but not
limited to, intellectual property laws. The Global Fund disclaims any and all liability and responsibility for any injury, death, damage or loss of any kind whatsoever that may arise as a result of, or in connection with the procurement, distribution and use of any product included in the list.

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV-EIA 17/49
 Version 48

29 Mars 2023

List of HIV Diagnostic test kits and equipments classified according to the Global Fund Quality Assurance Policy

CD4 Enumeration technologies

(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Manufacturer Anticipated Shelf life

Eligibility
Product Catalogue Product Name Cell counting Number of tests per kit Manufacturer (months)/ Specimen type Comments WHO or GHTF countries
number Storage temperature

End of Life (EOL)

260100025 25 cartridges/kit
of Pima
Venous and
12 months for reagents Instruments: 2024
PIMA CD4 Capillary whole
2 to 30°C for reagents (no support
100 blood available beyond
260100100
cartridges/kit that date)
WHO PQ
Abbott Rapid Diagnostics Jena GmbH, https://extranet.who.int/pqweb/sites
Absolute CD4+ Counts
Jena, Germany /default/files/PQDx_0099-032-
00_PimaCD4-Test_v6.0.pdf

260300003 PIMA Analyser Flow cytometry instrument DISCONTINUED

Flow cytometry instrument B30166 N/A

1x10ml B25697 18 ‐ 26°C/18M

Safety lancets,
alcohol swabs,
specimen
droppers(for
fingerstick whole
1x500ml B25698
B39101,B39102, B30166 blood), 2 chase
total CD3+, Beckman Coulter buffers, specimen
B25697, * CD3+CD4+,CD3+CD8+,
CD3+CD4+/CD3+CD8+ (ratio Life Sciences dropper for
WHO PQ
(PQ Public Report)
B25698, B23536, only) lymphocyte Miami, FL, USA (instrument serum/plasma, Venous Whole
Aquios CL flow cytometer N/A http://www.who.int/diagnostics_laboratory/evalua
B23538, B23533,
percentages and absolute counts; site) and whole blood Blood tions/151109_final_report_0156-053-
CD45+ absolute count; and CD45+
B23534, B23535, Low SS (lymphocytes) percentage Hialeah, FL, USA (reagent 00_aquios_cl_flow_cytometer.pdf
B25700, B23502 and absolute count. site)
4x50ml B23536 18 ‐ 26°C/12M

1 x 38ml,1 x 15ml (100 tests) B23538 18 ‐ 26°C/350 days

1 x 0.9ml (50 tests) B23533 2 ‐ 8°C/12M

1 x 0.9ml (50 tests) B23534 2 ‐ 8°C/12M

2x 3ml B23535 2 ‐ 8°C/270 days

2x 3ml B25700 2 ‐ 8°C/270 days

50 plates/box B23502 N/A

End of Life (EOL)

of FACSCount WHO PQ
BD FACSCount™ Instrument 337858: instrument
337858 * System with FACSCount™ Control Absolute CD4+, CD8+, system Becton, Dickinson and Company, BD
23 months (reagents)
Venous Whole
Instruments: 2024
(no support
(PQ Public Report)
(Instrument) 24 months (control) https://www.who.int/diagnost
Kit and BD FACSCount™ Reagent CD3+ Counts 340166: 25T /kit Biosciences, San Jose, USA Blood available beyond ics_laboratory/evaluations/1
340166 (control kit) 2 to 8°C that date)
Kit 340167: 50T/kit 21115_0124_045_00_public_
340167 (Test Kit) report_v2_final.pdf
DISCONTINUED

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV-CD4 18/49
 CD4 Enumeration technologies
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Manufacturer Anticipated Shelf life

Eligibility
Product Catalogue Product Name Cell counting Number of tests per kit Manufacturer (months)/ Specimen type Comments WHO or GHTF countries
number Storage temperature

End of Life (EOL)

337858 * of FACSCount WHO PQ
(Instrument) BD FACSCount™ Instrument 337858: instrument Instruments: 2024
Absolute and Percentage 15 months (reagents) (PQ Public Report)
340166 System with FACSCount™ system Becton, Dickinson and Company, BD Venous Whole (no support
CD4+ 24 months (control) https://www.who.int/diagnost
Control Kit and BD 340166: 25T/kit Biosciences, San Jose, USA Blood available beyond ics_laboratory/evaluations/1
(control kit) Counts 2 to 8°C
FACSCount™ CD4 Reagent Kit 339010: 50T/kit that date) 21115_0133_045_00_public_
339010 report_v1_final.pdf
(Test Kit) DISCONTINUED

Further Products
are available from
ERPD as RISK
CATEGORY-3 /
On Request on request on request on request on request on request on request on request
Non-Objection-
Letters are
required for
procurement

ERPD as RISK
CATEGORY-2 /
Non-Objection-
Letters are
342 447 required for
procurement
(Test Kit)
Absolute and Percentage -
According model Becton, Dickinson and Company, BD Whole venous
BD Multitest CD3/CD8/CD45/CD4 CD3/CD8/CD45/CD4 50T/kit with BD Trucount tubes on request End of Life (EOL) ERPD until 6th May 2023
(Instrument) Biosciences, San Jose, USA EDTA blood of FACSCalibur
Counts
According model Instruments: 2022
(control kit) (no support
available beyond
that date)

DISCONTINUED

ERPD as RISK
CATEGORY-2 /
Non-Objection-
Letters are
340 499 required for
procurement
(Test Kit)
Absolute and Percentage -
According model 50T/kit without BD Trucount Becton, Dickinson and Company, BD Whole venous
BD Multitest CD3/CD8/CD45/CD4 CD3/CD8/CD45/CD4 on request End of Life (EOL) ERPD until 6th May 2023
(Instrument) beads Biosciences, San Jose, USA EDTA blood of FACSCalibur
Counts
According model Instruments: 2022
(control kit) (no support
available beyond
that date)

DISCONTINUED

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV-CD4 19/49
 CD4 Enumeration technologies
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Manufacturer Anticipated Shelf life

Eligibility
Product Catalogue Product Name Cell counting Number of tests per kit Manufacturer (months)/ Specimen type Comments WHO or GHTF countries
number Storage temperature
651000:
instrument
657681: catridge
(100/box) and
655495: pipette
(100/box)
651000 Absolute and Percentage
BD FACSPresto™ Near-Patient CD4 Counter Becton, Dickinson and Company, BD human capillary -
657681 CD4+ counts and each box contain 100 catridges 23 months for cartridges
BD CD4%CD4/Hb Cartridge Packaging with Biosciences and venous blood End of Life (EOL) WHO PQ
Hemoglobin and 100 pipets 4 to 31°C for cartridges
655495 * BD FACSPresto™ Cartridges Kit
measurement
San Jose, California, USA specimens of FACSPresto
Instruments: 2024
(no support
available beyond
that date)

DISCONTINUED

CY-S-3022
(equipment) * CyFlow Instrument
Absolute and Percentage 14 months for reagents Venous Whole
CD4 Easy-Count Reagent Kit 100T/kit Sysmex Partec GmbH, Görlitz, Germany N/A WHO PQ
*
05-8401 (absolute) CD4% Easy-Count Reagent Kit
CD4+ Counts 2 to 8°C for reagents Blood

05-8405 (percentage)*

Rapid Diagnostic Test for qualitative testing based on CD4 technologies

Omega Diagnostics Limited

human venous
Semi-Quantitative Test Omega House, Hillfoots Business Village,
OD376 VISITECT®CD4 Advanced Disease 25T/kit 2 to 30°C whole blood or WHO PQ
(200 cells/µl cut-off) Alva, FK12 5DO, Scotland, United
capillary blood
Kingdom

Disclaimer:The Global Fund does not endorse or warrant the fitness of any product on the List for a particular purpose. In addition, the Global Fund assumes no responsibility for any misstatement or omission from the list and directs Principal Recipients of Global Fund grants to conduct their own independent confirmation that the information on a given product on the list is accurate before relying on it to
make a purchase order for that product, and to ensure that any purchase is in compliance with all the requirements of the Global Fund’s quality assurance policy. The Global Fund does not warrant or represent that the products listed have obtained regulatory approval for use in any particular country of the world, or that their use is otherwise in accordance with the national laws and regulations of any
country, including, but not limited to, intellectual property laws. The Global Fund disclaims any and all liability and responsibility for any injury, death, damage or loss of any kind whatsoever that may arise as a result of, or in connection with the procurement, distribution and use of any product included in the list.

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV-CD4 20/49
 Version 48

29 Mars 2023

List of HIV Diagnostic test kits and equipments classified according to the Global Fund Quality Assurance Policy

HIV Virological technologies

(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Product Name Anticipated

Manufacturer Product Recommended Eligibility
(Equipment, Reagents, controls and Reference detail Sensitivity Specificity Manufacturer Detection type Shelf life Specimen type Comments
Catalogue number storage temperature WHO or GHTF countries
caliberators) (months)

08N45-090 192T/kit 2 to 8°C

08N53-002 instrument

08N45 instrument HIV

Alinity m HIV-1 Abbott Molecular Inc Plasma and For consumables
3 x 12 CTRL N/A N/A Quantitative 12 months
refer to IFU
GHTF (CE mark)
08N45-080 Des Plaines IL, USA -25 to -15°C Serum
kit DNA

08N45-070 2x4 CAL kit -25 to -15°C

sample prep
09N12-001
kit 2

4N66-90 * 96T/kit -10°C

WHO PQ and GHTF (CE mark)
4N66-80 8 runs -10°C For a full list of consumables
Abbott Real Time HIV-1 required, see WHO Public
6K12-24 4x24 HIV 1 15 to 30°C For consumables Reports.
Qualitative Abbott Molecular Inc Plasma and
N/A N/A Qualitative 18 months refer to WHO For the Manual configuration
9K15-01 (Manual) instrument Des Plaines IL, USA dried blood eligible list
DNA see:
https://www.who.int/diagnostics_laboratory/eva
4N66-01 luations/pq-list/hiv-
vrl/180531_amended_final_pqpr_0151_027_00
_v2.pdf?ua=1

4N66-66 (optional) -30 to -10°C

4N66-90 * 96T/kit -10°C

WHO PQ and GHTF (CE mark)

9K14-02 instrument For a full list of consumables
required, see WHO Public
9K15-01 Abbott Real Time HIV-1 instrument
HIV 1 18 months Reports.
For consumables
Abbott Molecular Inc Plasma and For the automated
Qualitative N/A N/A Qualitative refer to WHO
4N66-80 8 runs Des Plaines IL, USA -10°C dried blood eligible list configuration
(m2000sp) DNA
see:
4N66-01 https://www.who.int/diagnostics_laboratory/eva
luations/pq-list/hiv-
vrl/191217_amended_final_pqpr_0084_027_00
6K12-24 4x24 15 to 30°C _v3.pdf?ua=1

4N66-66 (optional) -30 to -10°C

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV-Viral Load
21/49
 HIV Virological technologies
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Product Name Anticipated

Manufacturer Product Recommended Eligibility
(Equipment, Reagents, controls and Reference detail Sensitivity Specificity Manufacturer Detection type Shelf life Specimen type Comments
Catalogue number storage temperature WHO or GHTF countries
caliberators) (months)

2G31-90 * 96T/kit -10°C

2G31-80 8 runs - 10°C

2G31-70 4 calibrations - 10°C

Abbott Real Time HIV-1 HIV 1 WHO PQ and GHTF (CE mark)
For consumables https://www.who.int/diagnostics_laboratory/eva
2G31-66 Abbott Molecular Inc,
(Manual) N/A N/A Quantitative 18 Months Plasma refer to WHO luations/pq-list/hiv-
Des Plaines IL, USA
RNA eligible list vrl/180531_amended_final_pqpr_0151_027_00
1L68-09 software NA _v2.pdf?ua=1

9K15-01 instrument NA

04J70-24 4x24 15 to 30°C

04J71-93 15 to 30°C

2G31-90 * 96T/kit -10°C

2G31-010 * -15 to 25°C

09N02-001

09N03-001

2G31-80 8 runs - 10°C

2G31-70 4 calibrations - 10°C WHO PQ and GHTF (CE mark)

https://www.who.int/diagnosti
Abbott Real Time HIV-1 HIV1 Plasma & For consumables
9K15-01 instrument Abbott Molecular Inc, NA cs_laboratory/evaluations/pq-
(m2000sp) N/A N/A Quantitative 18 Months DBS refer to WHO
Des Plaines IL, USA list/hiv-
RNA Processing eligible list
2G31-66 vrl/191217_amended_final_pq
pr_0145_027_00_v9.pdf?ua=1
1L68-14 software NA

04J70-24 4x24 15 to 30°C

04J71-80

Optical Cal.
04J71-93 15 to 30°C
Kit

9K14-02 instrument NA

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV-Viral Load
22/49
 HIV Virological technologies
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Product Name Anticipated

Manufacturer Product Recommended Eligibility
(Equipment, Reagents, controls and Reference detail Sensitivity Specificity Manufacturer Detection type Shelf life Specimen type Comments
Catalogue number storage temperature WHO or GHTF countries
caliberators) (months)

3N06-01 instrument NA

2G31-90 * 96T/kit -10°C

2G31-80 8 runs -10°C

2G31-70 4 calibrations -10°C WHO PQ and GHTF (CE mark)

Abbott Real Time HIV-1 HIV1 For consumables
Abbott Molecular Inc, https://www.who.int/diagnostics_laboratory/eva
(m24sp) N/A N/A Quantitative 18 months Plasma refer to WHO luations/pq-list/hiv-
2G31-66 Des Plaines IL, USA -10°C eligible list
RNA vrl/191217_amended_pqpr_0083_027_00_abb
ott_real_time_hiv1_v3.pdf?ua=1
1L68-09

9K15-01 instrument

04J70-24

04J71-93

27030R001* m-PIMA Analyser

TM Instrument Not applicable Not applicable Not applicable
(former 270300001) (former Alere q System)

For consumables
Abbott Rapid and alternative
27011R010* Whole Blood,
10 Cartridges Diagnostics Jena 13 months 4-30°C Alere q (product
(former 270110010) N/A N/A Plasma WHO PQ
GmbH, 07749 Jena code 270300002)
Germany refer to WHO
27011R050* HIV-1/2 Public Report
m-PIMA HIV-1/2 Detect 50 Cartridges Qualitative 13 months 4-30°C
(former 270110050)
RNA

27011W50* 50 Cartridges 13 months 4-30°C

HIV-1
27015-W50 m-PIMA HIV-1/2 VL 50 tests/kit N/A NA Abbott Alere Quantitative 9 months 4 to 30°C Plasma
Technologies GmbH, RNA For consumables
Germany WHO PQ
refer to WHO PQ https://www.who.int/diagnostics_laboratory/evaluations/pq-
Loebstedter Str. 103- public report list/190923_pqdx_0359_032_00_amended_pqpr_v2.pdf?ua=1

105 07749 Jena

27030R001 m-PIMA Analyser instrument NA NA Germany NA NA NA NA

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV-Viral Load
23/49
 HIV Virological technologies
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Product Name Anticipated

Manufacturer Product Recommended Eligibility
(Equipment, Reagents, controls and Reference detail Sensitivity Specificity Manufacturer Detection type Shelf life Specimen type Comments
Catalogue number storage temperature WHO or GHTF countries
caliberators) (months)

AccuPower® HIV-1 Bioneer Corporation, 8-

HIV-1211 96T/kit 12 months -25°C to -15°C
Quantitative RT-PCR Kit 11, Munpyeongseo-ro, HIV-1 For consumables
and details of
N/A N/A Daedeok-gu, Daejeon, Quantitative EDTA Plasma componants refer GHTF (CE mark)
ExiStation™ Universal 34302, Republic of RNA to IFU
A-2200-N Instrument Korea Not applicable Not applicable
Molecular Diagnostic System

TR001-250IC Generic HIV Charge Virale 220 HIV1 EDTA or

Biocentric
NA NA Quantitative 18 months -30°C to -8°C citrated GHTF (CE mark)
Bandol France
TR001-440IC Generic HIV Charge Virale 440 RNA Plasma

280140 * instrument NA

280130 4x1lit 24 months 2 to 30°C

280131 4x1lit 18 months 2 to 30°C
Plasma dried WHO PQ and GHTF (CE mark)
280132 4x1lit HIV-1 15 months 2 to 8°C For consumables
NucliSENS EasyQ HIV-1 V2.0 bioMerieux SA, blood spot https://www.who.int/diagnostics_laboratory/eva
N/A N/A Quantitative refer to WHO PQ luations/pq-list/hiv-
(Automated) Marcy l'Etoile, France (venous public report
280133 4x1lit RNA 18 months 2 to 8°C vrl/pqdx_0127_016_00_public_report_v3.pdf?u
whole blood) a=1
280134 4x1lit 24 months 2 to 30°C
285056 instrument NA
200309
285033 48T/kit 18 months 2 to 8°C

200305 *
Plasma dried For consumables WHO PQ and GHTF (CE mark)
200293 48T/kit HIV-1 18 months 2 to 8°C
NucliSENS EasyQ HIV-1 V2.0 bioMerieux SA blood spot refer to WHO PQ https://www.who.int/diagnostics_laboratory/eva
N/A N/A Quantitative public report luations/pq-list/hiv-
(Semi Automated) Marcy l'Etoile, France (venous
RNA vrl/pqdx_0148_016_00_public_report_v2.pdf?
whole blood) ua=1

200292 48T/kit 24 months 2 to 30°C

285056 instrument NA
200309
285033 48T/kit 18 Months

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV-Viral Load
24/49
 HIV Virological technologies
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Product Name Anticipated

Manufacturer Product Recommended Eligibility
(Equipment, Reagents, controls and Reference detail Sensitivity Specificity Manufacturer Detection type Shelf life Specimen type Comments
Catalogue number storage temperature WHO or GHTF countries
caliberators) (months)

GeneXpert® Systems I, II, IV & For 10-channel

GX [Series} Instruments N/A N/A N/A N/A optical system
XVI
modules refer to
WHO PQ public
report see relevant WHO PQ Public
Infinity-48 GeneXpert® Infinity-48s Instrument N/A N/A N/A N/A Report
Infinity-80 GeneXpert® Infinity-80 Instrument N/A N/A N/A N/A

Only for Xpert HIV-

GXI-EDGE-L GeneXpert Edge System Instrument N/A N/A N/A N/A 1 Qual Assay
Cepheid Inc.,
Rontgenvagen 5
N/A N/A
SE-171, 54 Solna
Sweden HIV-1 For further
GXHIV-VL-CE-10 * Xpert HIV-1 Viral Load
10 cartridges
per pack
Quantitative
NA target
18 months 2-28ºC Plasma instruments refer to WHO PQ and GHTF (CE mark)
WHO Public Report

HIV-1 For further

GXHIV-QA-CE-10 * Xpert HIV-1 Qual Assay
10 cartridges
per pack
Qualitative NA
target
12 months 2–28 °C
Whole blood
and DBS
instruments refer to WHO PQ and GHTF (CE mark)
WHO Public Report

I19-0005 SAMBAprep instrument N/A N/A N/A N/A N/A N/A

I19-0004 SAMBAamp instrument N/A N/A Diagnostics for the Real N/A N/A N/A N/A
World, Sunnyvale, CA GHTF (CE mark)
94085 USA HIV-1 Semi
4100-12 SAMBA HIV-1 Semi-Q 12 tests N/A N/A Quantitative 9 months 2 to 37°C Plasma
RNA

I19-0006-AM SAMBA II Assay Module instrument N/A N/A N/A N/A N/A N/A

I19-0006-TM SAMBA II Tablet Module instrument N/A N/A Diagnostics for the Real N/A N/A N/A N/A
World, Sunnyvale, CA GHTF (CE mark)
94085 USA HIV-1 Semi
4400-12 SAMBA II HIV-1 Semi-Q 12 Tests N/A N/A QuantitativeR 9 months 2 to 37°C Plasma
NA

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV-Viral Load
25/49
 HIV Virological technologies
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Product Name Anticipated

Manufacturer Product Recommended Eligibility
(Equipment, Reagents, controls and Reference detail Sensitivity Specificity Manufacturer Detection type Shelf life Specimen type Comments
Catalogue number storage temperature WHO or GHTF countries
caliberators) (months)

o o
PRD-03000 100T/kit 2 C-8 C EDTA
Plasma, see
PRD-03001 5 runs 24 months -15 to -35°C IFU for dried
blood spots Multi-tube units
(DBS) (MTUs), Panther
PRD-03002 5 calibrators -15 to -35°C Waste Bag Kit,
Hologic, Inc HIV-1
Panther Waste
Aptima HIV-1 Quant Dx Assay 10210 Genetic Center Quantitative & WHO PQ
N/A N/A Bin Cover, Aptima
Kit (Panther System) Drive Qualitative
Assay Fluids, and
San Diego, CA 92121 RNA
Tips are included
and calculated
303095 instrument NA NA based on number
of kits ordered)

o o
PRD-03000B 500T/kit 2 C-8 C EDTA
Plasma, see
PRD-03001 10 runs 24 months -15 to -35°C IFU for dried
blood spots Multi-tube units
10 calibrators (DBS) (MTUs), Panther
PRD-03002 -15 to -35°C
Waste Bag Kit,
Hologic, Inc HIV-1
Panther Waste
Aptima HIV-1 Quant Dx Assay 10210 Genetic Center Quantitative &
N/A N/A Bin Cover, Aptima WHO PQ
Kit (Panther System) Drive Qualitative
Assay Fluids, and
San Diego, CA 92121 RNA
Tips are included
and calculated
303095 instrument NA NA based on number
of kits ordered)

4513263 24 -30°C to -15°C

20 months
artus HI Virus-1 RG RT-PCR
4513265 (Rotor-Gene Q 5plex) 96 QIAGEN GmbH, HIV-1 -30°C to -15°C
N/A N/A Qiagen Strasse 1, 40724 Quantitative Plasma GHTF (CE mark)
9001640 instrument Hilden, Germany RNA

extraction kit
60704 QIAamp DSP Virus Kit 12 months 2°C to 8°C
50T/kit

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV-Viral Load
26/49
 HIV Virological technologies
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Product Name Anticipated

Manufacturer Product Recommended Eligibility
(Equipment, Reagents, controls and Reference detail Sensitivity Specificity Manufacturer Detection type Shelf life Specimen type Comments
Catalogue number storage temperature WHO or GHTF countries
caliberators) (months)

4513363 24 -30°C to -15°C

17 months
artus HI Virus-1 QS-RGQ
4513366 72 -30°C to -15°C
(QIAsymphony SP/AS - Rotor-
Gene Q) QIAGEN GmbH, HIV-1
9001297 and 9001640 instrument N/A N/A Qiagen Strasse 1, 40724 Quantitative Plasma GHTF (CE mark, TGA)
Hilden, Germany RNA

QIAsymphony® DSP extraction kit

937055 14 months 15°C - 25°C
Virus/Pathogen 96T/kit

03279332001 * instrument NA

05527503001 instrument NA
For consumables
04862392001 COBAS AmpliPrep/COBAS software NA Plasma or refer to WHO WHO PQ and GHTF (CE mark)
Roche Molecular HIV1 eligible list
Taqman HIV-1 Test Version 2.0 PSC dried http://www.who.int/diagnostics_la
05807875001 software N/A N/A System, Branchburg, Quantitative NA
http://www.who.int/diagno boratory/evaluations/120502_012
(Taqman 48) plasma spot stics_laboratory/procureme
USA RNA 6_046_00_public_report_v1_final.
(with PCS) nt/140324_v11_pqed_prod pdf
03051315001 instrument NA ucts_eligible_for_procur_2
014.pdf?ua=1

05212294190 48T/kit 18 Months 2 to 8°C

03587797190 5.1L 24 months 2 to 30°C

03121453001 * instrument NA

03051315001 instrument NA

04862392001 software NA
For consumables
COBAS AmpliPrep/COBAS refer to WHO
Plasma or WHO PQ and GHTF (CE mark)
05807875001 Taqman HIV-1 Test Version 2.0 software Roche Molecular HIV1 NA eligible list
dried http://www.who.int/diagnostics_la
(Taqman 96) N/A N/A System, Branchburg, Quantitative http://www.who.int/diagno boratory/evaluations/120502_014
plasma spot stics_laboratory/procureme
05527503001 instrument USA RNA NA 7_046_00_public_report_v1_final.
(with PCS) nt/140324_v11_pqed_prod pdf
ucts_eligible_for_procur_2
014.pdf?ua=1
05212294190 48T/kit 18 Months 2 to 8°C

03587797190 5.1L 24 months 2 to 30°C

28127387001

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV-Viral Load
27/49
 HIV Virological technologies
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Product Name Anticipated

Manufacturer Product Recommended Eligibility
(Equipment, Reagents, controls and Reference detail Sensitivity Specificity Manufacturer Detection type Shelf life Specimen type Comments
Catalogue number storage temperature WHO or GHTF countries
caliberators) (months)

06693083190 * 48 T/KIT 22 months 2 to 8°C

03051315001 instrument

03279332001 instrument
COBAS® AmpliPrep/COBAS® WHO PQ and GHTF (CE mark)
03587797190 5.1L Roche Molecular HIV1 DNA & 24 months 2 to 30°C Plasma or For a full list of consumables
TaqMan® HIV-1 Qualitative
N/A N/A System, Branchburg, RNA dried blood required, see WHO Public Reports.
Test, http://www.who.int/diagnostics_laboratory/eval
06989861190 5 x 78ml USA Qualitative spots uations/141216_final_report_taqman48_0221_v
version 2.0 (TaqMan 48) 2.pdf?ua=1

05807875001 software

03516440001 instrument

28127387001

06693083190 * 48T/kit 22 months 2 to 8°C

03587797190 5.1L 24 months 2 to 30°C

06989861190 5 x 78ml 12 months 2 to 8°C

COBAS® AmpliPrep/COBAS® WHO PQ and GHTF (CE mark)
03051315001 instrument Roche Molecular HIV1 DNA & Plasma or For a full list of consumables
TaqMan® HIV-1 Qualitative
N/A N/A System, Branchburg, RNA dried blood required, see WHO Public Reports.
Test, http://www.who.int/diagnostics_laboratory/eval
03121453001 instrument USA Qualitative spots uations/141216_final_report_taqman96_0200_v
version 2.0 (TaqMan 96) 2.pdf?ua=1

28127387001

05807875001 software

03516440001 instrument

COBAS® TaqMan® HIV-1

5923468190 Test, Version 2 for use with 48 tests 24 months* 2 to 8°C
High pure system
Roche Molecular HIV-1
N/A N/A System, Branchburg, Quantitative Plasma GHTF (CE mark)
USA RNA
High Pure System Nucleic Acid
3502295001 48 tests 12 months* 15 to 25°C
Kit

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV-Viral Load
28/49
 HIV Virological technologies
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Product Name Anticipated

Manufacturer Product Recommended Eligibility
(Equipment, Reagents, controls and Reference detail Sensitivity Specificity Manufacturer Detection type Shelf life Specimen type Comments
Catalogue number storage temperature WHO or GHTF countries
caliberators) (months)

05 200 881 001 COBAS® z 480 instrument N/A N/A N/A N/A N/A N/A

05 200 890 001 COBAS® x 480 instrument N/A N/A N/A N/A N/A N/A
WHO PQ and GHTF (CE mark)
https://extranet.who.int/pqweb
Roche Molecular EDTA /sites/default/files/PQDx_0710-
System, Branchburg, Plasma, dried
HIV-1 118-00_cobasHIV-
USA plasma spot
COBAS® HIV-1 Test for use Quantitative & 1NucleicAcidTest-
08 792992190 120 tests N/A N/A 15 months 2 to 8°C (with PCS 4800System_v2.0.pdf
with 4800 Qualitative
card), dried
RNA
blood spots
(DBS)

05 200 881 001 COBAS® z 480 instrument N/A N/A N/A N/A N/A N/A

05 200 890 001 COBAS® x 480 instrument N/A N/A Roche Molecular N/A N/A N/A N/A WHO PQ and GHTF (CE mark)
System, Branchburg,
PQDx 0373-118-00
USA HIV-1
COBAS® Quantitative HIV-1
06 979599190 120 tests N/A N/A Quantitative 16 months N/A EDTA Plasma
Test for use with 4800
RNA

05524245001 and
COBAS® p 680 instrument N/A N/A N/A N/A N/A N/A
06379664001
Roche Diagnostics
GmbH / Roche
WHO PQ and GHTF (CE mark)
05412722001 COBAS® p 880 instrument N/A N/A Molecular System, N/A N/A N/A N/A
Branchburg, USA

HIV-1 EDTA
COBAS® HIV-1 Test for use
07000995190 96 tests/kit N/A N/A Quantitative 18 months 2 to 8°C Plasma, dried (with PCS card)
with 6800/8800 and PCS
RNA plasma spot

Roche Diagnostics Serum,

HIV-1/HIV-2
COBAS® HIV-1/HIV-2 Test for GmbH / Roche Plasma, dried
07862113190 96 tests/kit N/A N/A Qualitative 18 months 2 to 8°C GHTF (CE mark)
use with 6800/8800 Molecular System, blood spots
RNA
Branchburg, USA (DBS)

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV-Viral Load
29/49
 HIV Virological technologies
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Product Name Anticipated

Manufacturer Product Recommended Eligibility
(Equipment, Reagents, controls and Reference detail Sensitivity Specificity Manufacturer Detection type Shelf life Specimen type Comments
Catalogue number storage temperature WHO or GHTF countries
caliberators) (months)

COBAS® HIV-1 Quantitative Roche Diagnostics

HIV-1 EDTA
nucleic acid test for use on the GmbH / Roche
09040803190 192 tests/kit N/A N/A Quantitative 24 months 2 to 8°C Plasma, dried (with PCS card) GHTF (CE mark)
cobas® 5800/6800/8800 Molecular System,
RNA plasma spot
Systems Branchburg, USA

EDTA
COBAS® HIV-1/HIV-2 Roche Diagnostics
HIV-1/HIV-2 Plasma, dried
Qualitative nucleic acid test for GmbH / Roche
09040528190 192 tests/kit N/A N/A Qualitative 24 months 2 to 8°C plasma spot, (with PCS card) GHTF (CE mark)
use on the cobas® Molecular System,
RNA dried blood
5800/6800/8800 Systems Branchburg, USA
spots (DBS)

Sacace Biotechnologies HIV1

Human
V0-96/3FRT HIV Real-TM Quant Dx 96 N/A N/A Srl Quantitative 12 months 2 to 8ºC GHTF (CE mark)
Plasma
Como – Italy RNA
10729727 96T/kit 12 months -20°C
10729728 VERSANT® HIV-1 RNA 1.5 96T/kit Siemens Healthcare 12 months -80°C
Quantitative For consumables
10286026 Assay (kPCR) 96T/kit N/A N/A Diagnostics, Tarrytown 24 months 15 to 30°C Plasma GHTF (CE mark)
RNA refer to IFU
10286027 96T/kit NY, USA 24 months 4°C
instruments N/A N/A
N/A- NOT APPLICABLE
Disclaimer:The Global Fund does not endorse or warrant the fitness of any product on the List for a particular purpose. In addition, the Global Fund assumes no responsibility for any misstatement or omission from the list and directs Principal Recipients of Global Fund grants to conduct their own independent confirmation that the information on a
given product on the list is accurate before relying on it to make a purchase order for that product, and to ensure that any purchase is in compliance with all the requirements of the Global Fund’s quality assurance policy. The Global Fund does not warrant or represent that the products listed have obtained regulatory approval for use in any particular
country of the world, or that their use is otherwise in accordance with the national laws and regulations of any country, including, but not limited to, intellectual property laws. The Global Fund disclaims any and all liability and responsibility for any injury, death, damage or loss of any kind whatsoever that may arise as a result of, or in connection with
the procurement, distribution and use of any product included in the list.

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
HIV-Viral Load
30/49
 Version 48

29 Mars 2023

List of HIV Diagnostic test kits and equipments classified according to the Global Fund Quality Assurance Policy

Hepatitis B / Rapid Diagnostic Tests (RDTs)

(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark indicates that product is WHO prequalified

Anticipated
Manufacturer Shelf life
Number of Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte Specimen Type (months)/ Comments
tests per kit WHO or GHTF countries
number Storage
temperature

7D2942 * 20
WHO PQ
https://extranet.who.int/pqweb/sites/
7D2943 * Determine HBsAg 2 100 100.00% 99.70%
Abbott Diagnostics Medical Co.
Ltd, Matsudo, Japan
HBsAg detection
Serum/Plasma/
Whole Blood
18 Months
2 to 30°C
default/files/200123_pqdx_0451_013
_00_determine_hbsag_2_final_pqpr
_v2.pdf
7D2943 SET * 100

WHO PQ
https://www.who.int/diagnostics_labo

01FK10W * Bioline HBsAg WB 30 100.00% 99.00%

Abbott Diagnostics Korea
(Giheung-gu,Yongin-si, Korea)
HBsAg detection
Serum/Plasma/
Whole Blood
24 Months
1 to 40°C
ratory/evaluations/pq-
list/hbsag/200820_amended_pqpr_0
219_012_00_bioline_hbsag_wb_v4.p
df?ua=1

I10FRC25CE 25
Premier Medical Corporation, Serum/Plasma/ 24 Months
First Response® HBsAg Card Test 100.00% 100.00% HBsAg detection GHTF (CE mark)
Nani Daman, India Whole Blood 4 to 30°C
I10FRC30CE 30

PI10FRC05CE 5

PI10FRC10CE 10
Premier Medical Corporation, Serum/Plasma/ 24 Months
First Response® HBsAg Card Test 100.00% 100.00% HBsAg detection GHTF (CE mark)
Nani Daman, India Whole Blood 4 to 30°C
PI10FRC25CE 25

PI10FRC30CE 30

SD Biosensor, Inc Products available from

Serum/Plasma/ 24 Months ERPD as RISK CATEGORY-2 / Non-Objection-
09HBS10D STANDARD™ Q HBsAg Test 25 98.00% 100.00% (Gyeonggi-do 16690 HBsAg detection ERPD until 12th November 2022
Whole Blood 1 to 40°C Letters are required for procurement
Republic of Korea)

Products available from

on request on request on request on request on request on request HBsAg detection on request on request ERPD as RISK CATEGORY-3 / Non-Objection- ERPD
Letters are required for procurement

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
Hepatitis B and Hepatitis C simple assays 31/49
 Hepatitis B / Rapid Diagnostic Tests (RDTs)
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark indicates that product is WHO prequalified

Anticipated
Manufacturer Shelf life
Number of Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte Specimen Type (months)/ Comments
tests per kit WHO or GHTF countries
number Storage
temperature

N/A- NOT APPLICABLE

Disclaimer:The Global Fund does not endorse or warrant the fitness of any product on the List for a particular purpose. In addition, the Global Fund assumes no responsibility for any misstatement or omission from the list and directs Principal Recipients of Global Fund grants to conduct their own independent confirmation that the information on a given product on the list is accurate before relying on it to
make a purchase order for that product, and to ensure that any purchase is in compliance with all the requirements of the Global Fund’s quality assurance policy. The Global Fund does not warrant or represent that the products listed have obtained regulatory approval for use in any particular country of the world, or that their use is otherwise in accordance with the national laws and regulations of any
country, including, but not limited to, intellectual property laws. The Global Fund disclaims any and all liability and responsibility for any injury, death, damage or loss of any kind whatsoever that may arise as a result of, or in connection with the procurement, distribution and use of any product included in the list.

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
Hepatitis B and Hepatitis C simple assays 32/49
 Version 48

29 Mars 2023

List of HIV Diagnostic test kits and equipments classified according to the Global Fund Quality Assurance Policy

Hepatitis B Enzyme Immunoassays (EIAs) (including chemiluminescence immunoassays [CLIA])

(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Anticipated Shelf
Manufacturer life
Number of tests Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte (months)/ Comments
per kit WHO or GHTF countries
number Storage
temperature

B-1254/1.2 * 96/1 plate

B-1252/1.2 * 192/2 plates

B-1255/1.2 * 480/5 plates

RPC «Diagnostic Systems», Ltd.
24 months
WHO PQ
https://extranet.who.int/pqweb/sit
DS-EIA-HBsAg-0,01 100% 99.00% Nizhny Novgorod anti-HBsAg antibodies Human serum or plama specimen es/default/files/PQDx_0120-038-
2-8 ˚C
Russian Federation 00_DS-EIA-HBsAg-001_ENZYME-
1 plate 96 (for IMMUNOASSAY_v4.0.pdf

B-1256/1.2 * detection) or
48 (for
confirmation)

B-231/1.2 * 200 tests

72346 96 Serum and plasma specimen

Bio-Rad Laboratories, Marnes La see lot expiry Precision pipette (and tips), EIA plate washer, EIA plate
Monolisa HBsAg ULTRA assay 100% 99.94% anti-HBsAg Antibodies incubator, EIA plate reader, vacuum disposal system,
GHTF (CE mark)
Coquette, France 2 to 8°C
72348 480 measuring cylinders, reagent troughs

In EDTA/Citrate Plasma specimen

1. Stop Solution (0.5Mto 2MSulphuric Acid).
2. Freshly distilled or high quality deionized water

9F80-01 * 96
3. Micropipettes and Multichannel micropipettes of
appropriate volume.
4. Incubator capable of maintaining the temperature limits
defined in the assay protocol.
5. Moulded Heating Block (Code 5F09 02). For use in WHO PQ
laboratory incubators. http://www.who.int/diagnostics_la
12 months 6. Instrumentation boratory/evaluations/pq-
Murex HBsAg Version 3 100% 99.00% DiaSorin, Dartford, United Kingdon anti-HBsAg Antibodies a) Automated microplate strip washer.
2 to 8°C list/hbsag/161116_amended_final_
b) Microplate reader. public_report_0121_043_00.pdf?u
or a=1
c) Fully automated microplate processor.

*
All instruments must be validated before use.
9F80-05 480 7. Disposable Reagent Troughs. (Code 5F24 01).
8. Sodium hypochlorite for decontamination (Refer to Health
and Safety Information).
9. Sodium hydroxide solution (0.1M) (for instrument
decontamination)

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
Hepatitis B C -EIA 33/49
 Hepatitis B Enzyme Immunoassays (EIAs) (including chemiluminescence immunoassays [CLIA])
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Anticipated Shelf
Manufacturer life
Number of tests Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte (months)/ Comments
per kit WHO or GHTF countries
number Storage
temperature

Serum and plasma specimen

1. Stop Solution (0.5M to 2M Sulphuric Acid).
2. Freshly distilled or high quality deionised water
3. Micropipettes and Multichannel micropipettes of
appropriate volume.
4. Incubator capable of maintaining the temperature limits
defined in the assay protocol.
5. Moulded Heating Block (Code 5F09-02).
6. Instrumentation
2G27-01 * Murex HBsAg Confirmatory Version 3 50 100% 99.78% DiaSorin Dartford, United Kingdon anti-HBsAg Antibodies
17 months
2 to 8°C
a) Automated microplate stripwasher.
b) Microplate reader.
and

GHTF (CE mark, TGA)

or
c) Fully automated microplate processor.
All instruments must be validated before use.
7. Disposable Reagent Troughs. (Code 5F24-01).
8. Sodium hypochlorite for decontamination. (Refer to Health
and Safety Information)
9. Sodium hydroxide solution (0.1M). (Refer to Analytical
Precautions).

11 820 567 122 100

Human serum and plasma specimens
15 months
Elecsys® Anti-HBc IgM Roche Diagnostics GmbH HBc IgM antibodies GHTF (CE mark)
2 to 8°C
cobas e immunoassay analyzer
07 026 811 190 300

07 374 160 190 /

100
09 014 918 190
Human serum and plasma specimens

cobas e immunoassay analyzer

07 394 764 190 / 15 months
Elecsys® Anti-HBc II 200 Roche Diagnostics GmbH HBc IgG and IgM antibodies GHTF (CE mark)
09 109 463 190 2 to 8°C
NOTE: Consult the IFU for screening of blood donations
and for use of cadaveric blood specimens (specimens
collected post-mortem, non-heart-beating).
07 026 790 190 /
300
09 014 926 190

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
Hepatitis B C -EIA 34/49
 Hepatitis B Enzyme Immunoassays (EIAs) (including chemiluminescence immunoassays [CLIA])
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Anticipated Shelf
Manufacturer life
Number of tests Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte (months)/ Comments
per kit WHO or GHTF countries
number Storage
temperature

11 820 583 122 /

100
09 015 540 190
Human serum and plasma specimens

24 months cobas e 801 immunoassay analyzer

Elecsys® HBeAg 100.00% 99.90% Roche Diagnostics GmbH HCV antibodies GHTF (CE mark)
2 to 8°C
NOTE: Consult the IFU for diagnostic use
and for testing of blood donations
07 027 427 190 /
300
09 015 558 190

05 894 816 190 /

100
08 498 598 190
Human serum and plasma specimens

06 771 823 190 / 15 months cobas e immunoassay analyzer

Elecsys® Anti-HBs II 200 Roche Diagnostics GmbH HBs antibodies GHTF (CE mark)
08 498 601 190 2 to 8°C
NOTE: Consult the IFU for diagnostic use
and for testing of blood donations
07 026 854 190 /
300
08 498 610 190

04 687 787 190 /

100
08 814 856 190
Human serum and plasma specimens

cobas e immunoassay analyzer

07 914 482 190 / 12 months
Elecsys® HBsAg II 200 Roche Diagnostics GmbH HBsAg antigens GHTF (CE mark)
08 814 864 190 2 to 8°C
NOTE: Consult the IFU for screening of blood donations
and for use of cadaveric blood specimens (specimens
collected post-mortem, non-heart-beating).
07 251 076 190 /
300
08 814 848 190

N/A- NOT APPLICABLE

Disclaimer:The Global Fund does not endorse or warrant the fitness of any product on the List for a particular purpose. In addition, the Global Fund assumes no responsibility for any misstatement or omission from the list and directs Principal Recipients of Global Fund grants to conduct their own independent confirmation that the information on a given product on the list is accurate before relying on it to make a
purchase order for that product, and to ensure that any purchase is in compliance with all the requirements of the Global Fund’s quality assurance policy. The Global Fund does not warrant or represent that the products listed have obtained regulatory approval for use in any particular country of the world, or that their use is otherwise in accordance with the national laws and regulations of any country, including, but not
limited to, intellectual property laws. The Global Fund disclaims any and all liability and responsibility for any injury, death, damage or loss of any kind whatsoever that may arise as a result of, or in connection with the procurement, distribution and use of any product included in the list.

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
Hepatitis B C -EIA 35/49
 Version 48

29 Mars 2023

List of HIV Diagnostic test kits and equipments classified according to the Global Fund Quality Assurance Policy

Hepatitis B / Virological technologies

(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Product Name Anticipated

Manufacturer Product Recommended Eligibility
(Equipment, Reagents, controls and Reference detail Sensitivity Specificity Manufacturer Detection type Shelf life Specimen type Comments
Catalogue number storage temperature WHO or GHTF countries
caliberators) (months)

08N47-090 192T/kit 2 to 8°C

08N53-002 instrument

08N47 instrument HBV

Alinity m HBV Abbott Molecular Inc Plasma and
N/A N/A Quantitative 12 months GHTF (CE mark)
3 x 12 CTRL Des Plaines IL, USA Serum
08N47-080 DNA -25 to -15°C
kit

08N47-070 2x4 CAL kit -25 to -15°C

sample prep
09N12-001
kit 2

AccuPower® HBV Quantitative Bioneer Corporation, 8-

HBV-1211 96T/kit 12 months -25°C to -15°C For consumables
PCR Kit 11, Munpyeongseo-ro, HBV EDTA
and details of
N/A N/A Daedeok-gu, Daejeon, Quantitative Plasma and GHTF (CE mark)
componants refer to
ExiStation™ Universal 34302, Republic of DNA Serum IFU
A-2200-N Instrument Not applicable Not applicable
Molecular Diagnostic System Korea

GX [Series} GeneXpert® Dx Instruments N/A N/A N/A N/A

N/A N/A N/A N/A

Infinity-48 GeneXpert® Infinity-48 Instrument

Cepheid Inc., N/A N/A N/A N/A

Infinity-80 GeneXpert® Infinity-80 Instrument Rontgenvagen 5 N/A N/A N/A N/A
N/A N/A GHTF (CE mark)
SE-171, 54 Solna
GX4.0SWKIT
Sweden
or
GeneXpert® Dx Software Software N/A N/A N/A N/A
XPERTISE-G2-
SWKIT
HBV Serum /
10 cartridges
GXHBV-VL-CE-10 Xpert® HBV Viral Load Quantitative 18 months 2-35ºC EDTA
per pack
DNA Plasma

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
Hepatitis C -Viral Load
36/49
 Hepatitis B / Virological technologies
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Product Name Anticipated

Manufacturer Product Recommended Eligibility
(Equipment, Reagents, controls and Reference detail Sensitivity Specificity Manufacturer Detection type Shelf life Specimen type Comments
Catalogue number storage temperature WHO or GHTF countries
caliberators) (months)

4506263 24 -30°C to -15°C

17 months
4506265 artus HBV RG RT-PCR Kit 96 -30°C to -15°C
QIAGEN GmbH, HBV
(AS - Rotor-Gene Q)
N/A N/A Qiagen Strasse 1, 40724 Quantitative Plasma GHTF (CE mark)
9002042 instrument Hilden, Germany DNA

extraction kit
60704 QIAamp DSP Virus Kit 12 months 2°C - 8°C
96T/kit
4506363 artus HBV QS-RGQ Kit 24 -30°C to -15°C
17 months
4506366 (QIAsymphony® DSP / AS - 72 QIAGEN GmbH, HBV -30°C to -15°C
9001850 - 9002042 Rotor-Gene Q) instrument N/A N/A Qiagen Strasse 1, 40724 Quantitative Plasma GHTF (CE mark)
QIAsymphony® DSP extraction kit Hilden, Germany DNA
60704 14 months 15°C - 25°C
Virus/Pathogen 96T/kit

COBAS® AmpliPrep/COBAS®
04894570 190 TaqMan® 72 24 months 2°C - 8°C
HBV Test, version 2.0 not intended for use
as a screening
test for the presence
COBAS® AmpliPrep HBV of HBV in blood or
instrument n/a n/a Plasma and
Instrument N/A N/A Roche Molecular Quantitative blood products or GHTF (CE mark)
Serum as a diagnostic test
DNA
to confirm the
COBAS® TaqMan® Analyzer instrument n/a n/a presence of HBV
infection
COBAS® AmpliPrep/COBAS® extraction kit
03587797 190 24 months 2°C - 30°C
TaqMan® Wash Reagent 96T/kit
N/A- NOT APPLICABLE
Disclaimer:The Global Fund does not endorse or warrant the fitness of any product on the List for a particular purpose. In addition, the Global Fund assumes no responsibility for any misstatement or omission from the list and directs Principal Recipients of Global Fund grants to conduct their own independent confirmation that the information on a given
product on the list is accurate before relying on it to make a purchase order for that product, and to ensure that any purchase is in compliance with all the requirements of the Global Fund’s quality assurance policy. The Global Fund does not warrant or represent that the products listed have obtained regulatory approval for use in any particular country of the
world, or that their use is otherwise in accordance with the national laws and regulations of any country, including, but not limited to, intellectual property laws. The Global Fund disclaims any and all liability and responsibility for any injury, death, damage or loss of any kind whatsoever that may arise as a result of, or in connection with the procurement,
distribution and use of any product included in the list.

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
Hepatitis C -Viral Load
37/49
 Version 48

29 Mars 2023

List of HIV Diagnostic test kits and equipments classified according to the Global Fund Quality Assurance Policy

Hepatitis C / Rapid Diagnostic Tests (RDTs)

(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark indicates that product is WHO prequalified

Anticipated
Manufacturer Shelf life
Number of Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte Specimen Type (months)/ Comments
tests per kit WHO or GHTF countries
number Storage
temperature

02FK10 * 30 100.00% 99.40%

HCV antibody
detection
Serum/Plasma/
Whole Blood
24 Months
1 to 30°C
1 chase buffers,

WHO PQ
Sterile lancets, alcohol swabs, specimen
Abbott https://www.who.int/diagnostics_labo
02FK16 * Bioline HCV 25 100.00% 99.40% Diagnostics Korea Inc.
(Giheung-gu,Yongin-si, Korea)
HCV antibody
detection
Serum/Plasma/
Whole Blood
24 Months
1 to 30°C
droppers(for fingerstick whole blood), 1 chase
buffers, specimen dropper for serum/plasma,
ratory/evaluations/pq-
list/hcv/200820_amended_pqpr_025
whole blood
7_012_00_bioline_hcv_v8.pdf?ua=1

Safety lancets, alcohol swabs, specimen

02FK17 * 25 100.00% 99.40%

HCV antibody
detection
Serum/Plasma/
Whole Blood
24 Months
1 to 30°C
droppers(for fingerstick whole blood), 1 chase
buffers, specimen dropper for serum/plasma,
whole blood

with
HCV antibody Serum/Plasma/ 6 Months
90-1062 INSTI HCV Antibody Test 50 100.00% 97.67% bioLytical® Laboratories Inc support materials (lancet, pipette and alcohol GHTF (CE mark)
detection Whole Blood 2 to 30°C swab)

Accessories included: Plastic pipettes, sample

ITP01152-TC40 40 buffer

Accessories included: Plastic pipettes, sample

ITP01152-TC25 25 buffer
InTec Poducts Inc, (Haicang, HCV antibody Serum/Plasma/ 24 Months
Rapid Anti-HCV Test 99.70% 99.80% GHTF (CE mark)
Xiamen, P.R. China) detection Whole Blood 2 to 30°C Accessories included: Plastic pipettes, sample
ITP01153-TC40 40 buffer, safety lancets, and
alcohol swabs
Accessories included: Plastic pipettes, sample
ITP01153-TC10 10 buffer, safety lancets, and
alcohol swabs
ITPW01152- Accessories included: Plastic pipettes, sample
40
TC40* buffer

ITPW01152- InTec Poducts Inc, (Haicang, HCV antibody Serum/Plasma/ 24 Months Accessories included: Plastic pipettes, sample
Rapid Anti-HCV Test 25 99.70% 99.80% WHO PQ
TC25* Xiamen, P.R. China) detection Whole Blood 2 to 30°C buffer

ITPW01153- Accessories included: Plastic pipettes, sample

40 buffer, safety lancets, and
TC40* alcohol swabs

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
Hepatitis B and Hepatitis C simple assays 38/49
 Hepatitis C / Rapid Diagnostic Tests (RDTs)
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark indicates that product is WHO prequalified

Anticipated
Manufacturer Shelf life
Number of Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte Specimen Type (months)/ Comments
tests per kit WHO or GHTF countries
number Storage
temperature

1001-0270 * 25
WHO PQ
Serum/Plasma/
https://www.who.int/diagnostics_labo
OraSure Technologies Inc. HCV antibody Whole 18 Months
OraQuick HCV Rapid Antibody Test Kit 99.30% 99.50% for accessories see IFU ratory/evaluations/pq-
(Bethlehem, USA) detection Blood/Oral 2 to 30°C
list/hcv/170301_final_pq_report_PQ
Fluid
Dx_0244_055_00.pdf?ua=1

1001-0274 * 100

I03FRC25CE 25
Premier Medical Corporation, HCV antibody Serum/Plasma/ 25 Months
First Response® HCV Card Test 100.00% 100.00% GHTF (CE mark)
Nani Daman, India detection Whole Blood 4 to 30°C
I03FRC30CE 30

PI03FRC05CE 5

PI03FRC10CE 10
Premier Medical Corporation, HCV antibody Serum/Plasma/ 24 Months
First Response® HCV Card Test 100.00% 100.00% GHTF (CE mark)
Nani Daman, India detection Whole Blood 4 to 30°C
PI03FRC25CE 25

PI03FRC30CE 30

WHO PQ
https://www.who.int/diagnostics_labo
SD Biosensor, Inc
HCV antibody Serum/Plasma/ 24 Months ratory/evaluations/pq-
09HCV10D STANDARD Q HCV Ab Test 25 100.00% 97.67% (Gyeonggi-do 16690
detection Whole Blood 2 to 40°C list/hcv/200305_final_pqpr_0360_11
Republic of Korea)
7_00_standard_q_hcv_ab_test.pdf?u
a=1

N/A- NOT APPLICABLE

Disclaimer:The Global Fund does not endorse or warrant the fitness of any product on the List for a particular purpose. In addition, the Global Fund assumes no responsibility for any misstatement or omission from the list and directs Principal Recipients of Global Fund grants to conduct their own independent confirmation that the information on a given product on the list is accurate before relying on it to
make a purchase order for that product, and to ensure that any purchase is in compliance with all the requirements of the Global Fund’s quality assurance policy. The Global Fund does not warrant or represent that the products listed have obtained regulatory approval for use in any particular country of the world, or that their use is otherwise in accordance with the national laws and regulations of any
country, including, but not limited to, intellectual property laws. The Global Fund disclaims any and all liability and responsibility for any injury, death, damage or loss of any kind whatsoever that may arise as a result of, or in connection with the procurement, distribution and use of any product included in the list.

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
Hepatitis B and Hepatitis C simple assays 39/49
 Version 48

29 Mars 2023

List of HIV Diagnostic test kits and equipments classified according to the Global Fund Quality Assurance Policy

Hepatis C Enzyme Immunoassays (EIAs) (including chemiluminescence immunoassays [CLIA])

(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Anticipated Shelf
Manufacturer life
Number of tests Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte (months)/ Comments
per kit WHO or GHTF countries
number Storage
temperature

WHO PQ
https://www.who.int/diagnostics_l
Abbott
12 months Human serum and plasma specimens
aboratory/evaluations/pq-
6L47-29 ARCHITECT HCV Ag assay 100 98% 99.50% Denka Seiken Co., LTD, Kagamida HCV antigens
2 to 8°C list/hcv/190731_pqdx_0374_130_0
Factory
0_architecth_hcv.pdf?ua=1
GHTF (CE mark)

WHO PQ
72561 * 96
Serum and plasma specimen
https://www.who.int/diagnostics_l
aboratory/evaluations/pq-
Bio-Rad Laboratories, Marnes La see lot expiry Precision pipette (and tips), EIA plate washer, EIA plate
Monolisa HCV Ag-Ab ULTRA V2 assay 100% 99.94% HCV antigens / antibodies incubator, EIA plate reader, vacuum disposal system,
list/hcv/200124_fina_pqpr_pqdx_
Coquette, France 2 to 8°C
measuring cylinders, reagent troughs 0229_031_00_monolisa_hcv_ag_a

72562 * 480
b_ultra.pdf?ua=1
GHTF (CE mark)

In EDTA/Citrate Plasma specimen

7F51-01 * 96 1. Stop Solution (0.5Mto 2MSulphuric Acid).
2. Freshly distilled or high quality deionized water
3. Micropipettes and Multichannel micropipettes of
appropriate volume.
4. Incubator capable of maintaining the temperature limits
defined in the assay protocol.
5. Moulded Heating Block (Code 5F09 02). For use in
laboratory incubators. WHO PQ
DiaSorin, Dartford, South Africa (Pty) 12 months 6. Instrumentation https://extranet.who.int/pqweb/sit
Murex anti-HCV Version 4 100% 99.40% HCV antigens a) Automated microplate strip washer.
Ltd 2 to 8°C es/default/files/180517_amended_f
b) Microplate reader. inal_pqpr_0164_059_00_v7.pdf
or
c) Fully automated microplate processor.
All instruments must be validated before use.
7F51-02 * 480 7. Disposable Reagent Troughs. (Code 5F24 01).
8. Sodium hypochlorite for decontamination (Refer to Health
and Safety Information).
9. Sodium hydroxide solution (0.1M) (for instrument
decontamination)

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
Hepatitis B C -EIA 40/49
 Hepatis C Enzyme Immunoassays (EIAs) (including chemiluminescence immunoassays [CLIA])
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Anticipated Shelf
Manufacturer life
Number of tests Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte (months)/ Comments
per kit WHO or GHTF countries
number Storage
temperature

80068 * 192 WHO PQ

http://www.who.int/diagnostics_la
Fujirebio Europe NV 16 months
INNOTEST HCV Ab IV 100.00% 100.00% HCV antigens Human serum and plasma specimens boratory/evaluations/pq-
(Gent, Belgium) 2 to 8°C
list/hcv/180215_final_pq_report_p
80330 * 480 qdx_0201_073_00.pdf?ua=1

WHO PQ
http://www.who.int/diagnostics_la
80538 * INNO-LIA HCV Score 20 100.00% 99.90%
Fujirebio Europe NV
(Gent, Belgium)
HCV antigens
15 months
2 to 8°C
Human serum and plasma specimens boratory/evaluations/150729_final
_report_0202_073_00_hcv.pdf?ua
=1

06 368 921 190 /

100
08 836 981 190
Human serum and plasma specimens

cobas e 801 immunoassay analyzer

06 427 405 190 / 12 months
Elecsys® Anti-HCV II 200 100.00% 99.90% Roche Diagnostics GmbH HCV antibodies GHTF (CE mark)
08 837 031 190 2 to 8°C
NOTE: Consult the IFU for screening of blood donations
and for use of cadaveric blood specimens (specimens
collected post-mortem, non-heart-beating).
07 026 889 190
/ 08 837 058 300
190

N/A- NOT APPLICABLE

Disclaimer:The Global Fund does not endorse or warrant the fitness of any product on the List for a particular purpose. In addition, the Global Fund assumes no responsibility for any misstatement or omission from the list and directs Principal Recipients of Global Fund grants to conduct their own independent confirmation that the information on a given product on the list is accurate before relying on it to make a
purchase order for that product, and to ensure that any purchase is in compliance with all the requirements of the Global Fund’s quality assurance policy. The Global Fund does not warrant or represent that the products listed have obtained regulatory approval for use in any particular country of the world, or that their use is otherwise in accordance with the national laws and regulations of any country, including, but not
limited to, intellectual property laws. The Global Fund disclaims any and all liability and responsibility for any injury, death, damage or loss of any kind whatsoever that may arise as a result of, or in connection with the procurement, distribution and use of any product included in the list.

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
Hepatitis B C -EIA 41/49
 Version 48

29 Mars 2023

List of HIV Diagnostic test kits and equipments classified according to the Global Fund Quality Assurance Policy

Hepatitis C / Virological technologies

(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Product Name Anticipated

Manufacturer Product Recommended Eligibility
(Equipment, Reagents, controls and Reference detail Sensitivity Specificity Manufacturer Detection type Shelf life Specimen type Comments
Catalogue number storage temperature WHO or GHTF countries
caliberators) (months)

4J86-90 * 96T/kit <-10°C

GHTF (CE mark) and

various instrument HCV Plasma and WHO PQ
Abbott Realtime HCV Abbott Molecular Inc
N/A N/A Quantitative 18 months Serum and https://www.who.int/diagnostics_laboratory/eva
Des Plaines IL, USA luations/pq-
4J86-80 CTRL kit RNA <-10°C DBS list/hcv/200915_amended_final_pqpr_0450_02
7_00_abbot_realtime_hcv.pdf

4J86-70 CAL kit <-10°C

08N50-090 * 4 x 48T/kit 2 to 8°C

08N53-002 instrument

HCV
08N50 instrument Qualitative
Alinity m HCV Abbott Molecular Inc Plasma and GHTF (CE mark) and
N/A N/A and 12 months
3 x 12 CTRL Des Plaines IL, USA Serum WHO PQ
08N50-080 Quantitative -25 to -15°C
kit RNA

08N50-070 2x4 CAL kit -25 to -15°C

sample prep
09N12-001
kit 2

AccuPower® HCV Quantitative Bioneer Corporation, 8-

HCV-1211 96T/kit 12 months -25°C to -15°C For consumables
RT-PCR Kit 11, Munpyeongseo-ro, HCV
EDTA Plasma and details of
N/A N/A Daedeok-gu, Daejeon, Quantitative GHTF (CE mark)
and Serum componants refer
ExiStation™ Universal 34302, Republic of RNA to IFU
A-2200-N Instrument Not applicable Not applicable
Molecular Diagnostic System Korea

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
Hepatitis C -Viral Load
42/49
 Hepatitis C / Virological technologies
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Product Name Anticipated

Manufacturer Product Recommended Eligibility
(Equipment, Reagents, controls and Reference detail Sensitivity Specificity Manufacturer Detection type Shelf life Specimen type Comments
Catalogue number storage temperature WHO or GHTF countries
caliberators) (months)

GX [Series} GeneXpert® Dx Instruments N/A N/A N/A N/A

For 10-channel
optical system
N/A N/A N/A N/A modules refer to
Infinity-48 GeneXpert® Infinity-48 Instrument
WHO PQ public
report
N/A N/A N/A N/A
Infinity-80 GeneXpert® Infinity-80 Instrument N/A N/A N/A N/A
Cepheid Inc., GHTF (CE mark) and
GeneXpert® Dx Software WHO PQ
Version 4.6a or Rontgenvagen 5
GX4.0SWKIT N/A N/A https://www.who.int/diagnostics_laboratory/eva
higher (GeneXpert Dx systems); SE-171, 54 Solna luations/pq-
or Software Sweden N/A N/A N/A N/A list/hcv/190730_amended_pqpr_0260_070_00
or .pdf?ua=1
XPERTISE-G2-SWKIT
Xpertise 6.2a or higher
(Infinity80/Infinity-48s)
HCV
Qualitative Serum /
GXHCV-VL-CE-10 * Xpert® HCV Viral Load
10 cartridges
per pack
and
Quantitative
12 months 2-28ºC EDTA Plasma
/ blood
RNA

HCV
Cepheid Inc.,
Qualitative EDTA Plasma
Rontgenvagen 5
GXHCV-FS-CE-10* Xpert HCV VL Fingerstick 10 N/A N/A and 12 months 2-28ºC / capillary & WHO PQ
SE-171, 54 Solna
Quantitative venous blood
Sweden
RNA

HCV GHTF (CE mark) and WHO PQ

Genedrive Diagnostics https://www.who.int/diagnostics_laboratory/eva
ID-HCV-03 Genedrive HCV ID Kit 10 99.8 100 Qualitative 12 months 2 to 30°C Plasma luations/pq-
Ltd., United Kingdom
RNA list/hcv/200501_final_pqpr_pqdx_0380_133_0
0_genedrive_hcv_id_v1.pdf?ua=1

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
Hepatitis C -Viral Load
43/49
 Hepatitis C / Virological technologies
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark is WHO prequalified

Product Name Anticipated

Manufacturer Product Recommended Eligibility
(Equipment, Reagents, controls and Reference detail Sensitivity Specificity Manufacturer Detection type Shelf life Specimen type Comments
Catalogue number storage temperature WHO or GHTF countries
caliberators) (months)

4518263 24 -30°C to -15°C

17 months
4518265 artus HCV RG RT-PCR Kit 96 -30°C to -15°C
(AS - Rotor-Gene Q MDx) QIAGEN GmbH, HCV
N/A N/A Qiagen Strasse 1, 40724 Quantitative Plasma GHTF (CE mark)
9002022 instrument Hilden, Germany RNA

extraction kit
60704 QIAamp DSP Virus Kit 12 months 2°C - 8°C
96T/kit

4518363 24 -30°C to -15°C

17 months
4518366 72 -30°C to -15°C
artus HCV QS-RGQ Kit
(QIAsymphony® DSP / AS -
Rotor-Gene Q)
QIAGEN GmbH, HCV
9001850 - 9002042 instrument N/A N/A Qiagen Strasse 1, 40724 Quantitative Plasma GHTF (CE mark)
Hilden, Germany RNA

QIAsymphony® DSP extraction kit

937055 14 months 15°C - 25°C
Virus/Pathogen 96T/kit

Roche Diagnostics
HCV EDTA
COBAS® HCV Test for use with GmbH / Roche
06997732 190 96 tests/kit N/A N/A Quantitative 18 months 2 to 8°C Plasma, dried (with PCS card) WHO PQ
5800/6800/8800 and PCS Molecular System,
RNA plasma spot
Branchburg, USA
N/A- NOT APPLICABLE
Disclaimer:The Global Fund does not endorse or warrant the fitness of any product on the List for a particular purpose. In addition, the Global Fund assumes no responsibility for any misstatement or omission from the list and directs Principal Recipients of Global Fund grants to conduct their own independent confirmation that the information on a
given product on the list is accurate before relying on it to make a purchase order for that product, and to ensure that any purchase is in compliance with all the requirements of the Global Fund’s quality assurance policy. The Global Fund does not warrant or represent that the products listed have obtained regulatory approval for use in any particular
country of the world, or that their use is otherwise in accordance with the national laws and regulations of any country, including, but not limited to, intellectual property laws. The Global Fund disclaims any and all liability and responsibility for any injury, death, damage or loss of any kind whatsoever that may arise as a result of, or in connection with
the procurement, distribution and use of any product included in the list.

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
Hepatitis C -Viral Load
44/49
 Version 48

29 Mars 2023

List of HIV Diagnostic test kits and equipments classified according to the Global Fund Quality Assurance Policy

Treponema Pallidum Infections for diagnosis of Syphilis to initiate patient treatment /Rapid Diagnostic Tests (RDTs)
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark indicates that product is WHO prequalified

Anticipated
Manufacturer Shelf life
Number of Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte Specimen Type (months)/ Comments
tests per kit WHO or GHTF countries
number Storage
temperature

06FK30 *
WHO PQ
Abbott https://extranet.who.int/pqweb/sites/
06FK35 * Bioline HIV/Syphilis Duo
(formerly SD Bioline HIV/Syphilis Duo)
25
HIV-100%
Syphilis-87%
99.5%
99.5%
Diagnostics Korea Inc.
(Giheung-gu,Yongin-si, Korea)
HIV/TP-antibodies
Serum/Plasma/
Whole Blood
24 Months
1 to 30°C
For consumables refer to WHO Public Report default/files/PQDx_0179-012-
00_BiolineHIVSyphilisDuo_PublicRe
port_v7.0.pdf

06FK37 *
I20FRC25 * 25 T/kit
30 T/kit Premier Medical Corporation
I20FRC30 First Response® HIV1+2/Syphilis Combo Card HIV-100% 99.5% Serum/Plasma/ 30 Months For consumables refer to WHO Public Report
WHO PQ
50 T/kit Private Limited HIV/TP-antibodies https://www.who.int/diagnostics_laboratory/evaluations/pq-
I20FRC50 Test Syphilis-99% 100% Whole Blood 4 to 30°C list/190625_pqdx_0364_010_00_final_pqpr.pdf
60 T/kit (Sarigam, Gujarat, India)
I20FRC60 100T/kit
I20FRC100

SD Biosensor Inc
(16, Deogyeong-daero,
STANDARD™ Q HIV/Syphilis Combo HIV-100% HIV-99.9% Serum/Plasma/ 24 Months
09HIV20D 25 T/kit 1556 beon-gil, Yeongtong-gu, HIV/TP-antibodies For consumables refer to WHO Public Report WHO PQ
Test Syphilis-98.8% Syphilis-100% Whole Blood 2 to 40°C
Suwon-si, Gyeonggi-do 16690
Republic of Korea)

Further Products are available from

Serum/Plasma/
on request on request on request on request on request on request HIV/TP-antibodies on request ERPD as RISK CATEGORY-3 / Non-Objection- ERPD
Whole Blood Letters are required for procurement

7D2452 * 30

7D2453 * Determine Syphilis TP 100 Syphilis-100% 98.70%

Abbott Diagnostics Medical
Co., Ltd.
TP-antibodies
Serum/Plasma/
Whole Blood
14 Months
2 to 30°C
For consumables refer to WHO Public Report WHO PQ

7D2453SET * 100

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
Syphilis simple tests 45/49
 Treponema Pallidum Infections for diagnosis of Syphilis to initiate patient treatment /Rapid Diagnostic Tests (RDTs)
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark indicates that product is WHO prequalified

Anticipated
Manufacturer Shelf life
Number of Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte Specimen Type (months)/ Comments
tests per kit WHO or GHTF countries
number Storage
temperature

PI08FRC25 * First Response® Syphilis Anti-TP Card Test

25 T/kit
50 T/kit 99.60% 100.00%
Premier Medical Corporation
Private Limited TP-antibodies
Serum/Plasma/ 24 Months For consumables refer to WHO Public Report
WHO PQ
https://www.who.int/diagnostics_laboratory/eval
PI08FRC50 Whole Blood 4 to 30°C uations/pq-
100T/kit (Sarigam, Gujarat, India) list/190625_pqdx_0364_010_00_final_pqpr.pdf
PI08FRC100

ERPD as CATEGORY-2, meaning that

BIOLINE Syphilis 3.0 Abbott Diagnostics Korea Serum/Plasma/ 24 Months procurement with Global Fund resources of this
06FK10 30 99.30% 99.50% TP-antibodies product will be permitted / Non-Objection- ERPD until 5th May 2023
(former SD Bioline Syphilis 3.0) (Giheung-gu,Yongin-si, Korea) Whole Blood 1 to 30°C
Letter required for procurement

SD Biosensor Inc
(16, Deogyeong-daero, Further Products are available from
09SYP10C Serum/Plasma/
STANDARD™ Q Syphilis Ab Test 25 on request on request 1556 beon-gil, Yeongtong-gu, TP-antibodies on request ERPD as RISK CATEGORY-3 / Non-Objection- ERPD until 25th August 2023
09SYP10D Whole Blood Letters are required for procurement
Suwon-si, Gyeonggi-do 16690
Republic of Korea)

N/A- NOT APPLICABLE

Disclaimer:The Global Fund does not endorse or warrant the fitness of any product on the List for a particular purpose. In addition, the Global Fund assumes no responsibility for any misstatement or omission from the list and directs Principal Recipients of Global Fund grants to conduct their own independent confirmation that the information on a given product on the list is accurate before relying on it to
make a purchase order for that product, and to ensure that any purchase is in compliance with all the requirements of the Global Fund’s quality assurance policy. The Global Fund does not warrant or represent that the products listed have obtained regulatory approval for use in any particular country of the world, or that their use is otherwise in accordance with the national laws and regulations of any
country, including, but not limited to, intellectual property laws. The Global Fund disclaims any and all liability and responsibility for any injury, death, damage or loss of any kind whatsoever that may arise as a result of, or in connection with the procurement, distribution and use of any product included in the list.

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
Syphilis simple tests 46/49
 Version 48

29 Mars 2023

List of HIV Diagnostic test kits and equipments classified according to the Global Fund Quality Assurance Policy

Treponema Pallidum Infections for diagnosis of Syphilis to initiate patient treatment / (other than RDTs)
(not intended to be used as a donor screening tests – unless otherwise specified)

Product codes superscripted with a * (star) mark indicates that product is WHO prequalified

Shelf life
Manufacturer
Number of (months)/ Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte Specimen Type Comments
tests per kit Storage WHO or GHTF countries
number
temperature

removed removed removed removed removed removed removed removed removed removed removed

RPR / VDRL

Products are available from

ERPD as RISK CATEGORY-3 / Non-
on request on request on request on request on request on request on request on request on request ERPD
Objection-Letters are required for
procurement

TPHA / TPPA

Products are available from

ERPD as RISK CATEGORY-3 / Non-
on request on request on request on request on request on request on request on request on request Objection-Letters are required for ERPD
procurement

ELISA / EIA / LIA

removed removed removed removed removed removed removed removed removed removed removed

N/A- NOT APPLICABLE

Disclaimer:The Global Fund does not endorse or warrant the fitness of any product on the List for a particular purpose. In addition, the Global Fund assumes no responsibility for any misstatement or omission from the list and directs Principal Recipients of Global Fund grants to conduct their own independent confirmation that the information on a given product on the list is accurate before
relying on it to make a purchase order for that product, and to ensure that any purchase is in compliance with all the requirements of the Global Fund’s quality assurance policy. The Global Fund does not warrant or represent that the products listed have obtained regulatory approval for use in any particular country of the world, or that their use is otherwise in accordance with the national laws
and regulations of any country, including, but not limited to, intellectual property laws. The Global Fund disclaims any and all liability and responsibility for any injury, death, damage or loss of any kind whatsoever that may arise as a result of, or in connection with the procurement, distribution and use of any product included in the list.

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
Syphilis simple tests 47/49
 Version 48

29 Mars 2023

List of COIM Diagnostic tests

(included to support Global Fund Policy for Co-Infections and Co-Morbidities)

NOTE: The particular requirements from section 8 of the Global Fund QA Policy of Diagnostic Products do not apply for these products. However, the requirements of section 7 should be met. An additional assessment by WHO PQ or the ERP-D provides
increased assurance on meeting the needs of low-ressource settings.

Product codes superscripted with a * (star) mark indicates that product is WHO prequalified

Shelf life
Manufacturer
Number of (months)/ Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte Specimen Type Comments
tests per kit Storage WHO or GHTF countries
number
temperature

Human Papilloma Virus

WHO PQ
https://www.who.int/diagnostics_labo

02N09-092 * Abbott RealTime High Risk HPV 96 N/A N/A

Abbott GmbH & Co.KG
(Delkenheim, Germany)
HPV DNA detection cervical cells
18 Months
2 to 28°C
ratory/evaluations/pq-
list/191010_pqdx_0455_180_00_pqp
r_abbott_realtime_highrisk_hpv.pdf?
ua=1

614015 * careHPV™ Test 96

QIAGEN GmbH, Qiagen
12 month /
4°C to -25°C
careHPV Collection Medium (CCM)
WHO PQ
https://www.who.int/diagnostics_labo
N/A N/A Strasse 1, 40724 Hilden, HPV DNA detection cervical cells ratory/evaluations/pq-
and careBrushes Foam specimen tube rack
Germany list/180713_pqpr_pqdx_0085_028_0
9001772 * careHPV Test System instrument N/A 0_carehpv_with_labelling.pdf?ua=1

WHO PQ
cervical cells
https://www.who.int/diagnostics_labo
GXHPV-CE-10 * Xpert HPV Assay 10 N/A N/A
Cepheid AB
(Solna, Sweden)
HPV DNA detection
collected in
PreservCytSolut
18 Months
2 to 28°C
ratory/evaluations/pq-list/hiv-
vrl/171221_final_pq_report_pqdx_02
ion
68_070_00.pdf?ua=1

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
Other HIV COIMs Tests 48/49
 NOTE: The particular requirements from section 8 of the Global Fund QA Policy of Diagnostic Products do not apply for these products. However, the requirements of section 7 should be met. An additional assessment by WHO PQ or the ERP-D provides
increased assurance on meeting the needs of low-ressource settings.

Product codes superscripted with a * (star) mark indicates that product is WHO prequalified

Shelf life
Manufacturer
Number of (months)/ Eligibility
Product Catalogue Product Name Initial Sensitivity Final Specificity Manufacturer Analyte Specimen Type Comments
tests per kit Storage WHO or GHTF countries
number
temperature

Cryptococcal Antigen

cryptococcus
11200001 BIOSYNEX Crypto PS 20 see IFU see IFU Biosynex SA see IFU see IFU
antigens

Diagnostic Products for CrAg testing were

cryptococcus assessed by the ERPD on behalf of Unitaid.
CR2003 CrAg Lateral Flow Assay see IFU see IFU see IFU IMMY, Inc see IFU see IFU
antigens
Section 8 of the GF QA Policy is not applicable
to these products, however section 7 and all
other parts of the QA Policy are applicable.

The listing is motivated to support the Global

Fund Policy for Co-Infections and Co-
Latex Cryptococcus Antigen Detection cryptococcus Morbidities. There is no need for Non-
CR1003 CR1004 see IFU see IFU see IFU IMMY, Inc see IFU see IFU
System (CrAg® Latex Kit) antigens Objection-Letters with Global Fund resources
in this case.

ALPHA Cryptococcal Antigen Enzyme cryptococcus

CRY101 see IFU see IFU see IFU IMMY, Inc see IFU see IFU
Immunoassay (CrAg® EIA) antigens

Disclaimer:The Global Fund does not endorse or warrant the fitness of any product on the List for a particular purpose. In addition, the Global Fund assumes no responsibility for any misstatement or omission from the list and directs Principal Recipients of Global Fund grants to conduct their own independent confirmation that the information on a given product on the list is accurate before relying on it to
make a purchase order for that product, and to ensure that any purchase is in compliance with all the requirements of the Global Fund’s quality assurance policy. The Global Fund does not warrant or represent that the products listed have obtained regulatory approval for use in any particular country of the world, or that their use is otherwise in accordance with the national laws and regulations of any
country, including, but not limited to, intellectual property laws. The Global Fund disclaims any and all liability and responsibility for any injury, death, damage or loss of any kind whatsoever that may arise as a result of, or in connection with the procurement, distribution and use of any product included in the list.

LIST OF DIAGNOSTIC TEST KITS FOR HIV

classified according to the GF QA Policy
Other HIV COIMs Tests 49/49