List of SARS-Cov-2 Diagnostic Test

Version 2 8 May 2020

List of SARS-CoV-2 Diagnostic test kits and equipments eligible for procurement according to Board Decision on Additional Support for Country Responses to COVID-19 (GF/B42/EDP11)

SARS-CoV-2 Nuclear Acid Amplification Technologies

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

Anticipated Manufacturer Product Product Name Platform Recommended Eligibility Reference detail Manufacturer Detection type Shelf life Specimen type Comments Catalogue number (IVD product) (Extraction and amplification equipement) storage temperature WHO EUL or others (months)

1DROP INC. (imported For consumables E gene and nasopharyng and details of 444213 1COPY COVID-19 QPCR KIT 24T/kit by Luminarie Canada 6 months 15 to 30°C Health Canada/Interim Order RdRp gene eal swabs componants refer Inc.) to IFU

For consumables US FDA EUA Abbott Diagnostics nasopharyng and details of 190-000 ID NOW COVID-19 Test Kit 96T/kit ID NOW Instrument RdRp segment see IFU 2 to 30 ºC Health Canada/Interim Order Scarborough Inc eal swabs componants refer to IFU WHO EUL

For consumables US FDA EUA Abbott RealTime SARS-CoV-2 RdRp and N and details of Health Canada/Interim Order 09N77-090 96T/kit Abbott m2000 Abbott Molecular see IFU -25 to -15 ºC see IFU RT-PCR Kit genes componants refer TGA to IFU WHO EUL

CFX96™ Touch Real- Time PCR Detection AltoStar® System (Bio-Rad) For consumables RealStar® SARS-CoV-2 RT- Altona Diagnostics and details of 821025 384T/kit Automation see IFU -25 to -15 ºC see IFU US FDA EUA PCR Kit U.S. GmbH componants refer System AM16 CFX96™ Touch Deep to IFU Well Real-Time PCR Detection System (BioRad nasal, N gene and nasopharyng For consumables iAMP® COVID-19 Detection CFX96 Real-Time and details of iAMP-COVID19-100 100T/kit not required Atila BioSystems, Inc. the ORF-1ab 12 months lower than -20 ºC eal and US FDA EUA Kit System componants refer gene oropharynge to IFU al swab

AusDiagnostics respiratory For consumables AusDiagnostics Pty Ltd and details of virus panel (including SARS- see IFU see IFU see IFU TGA (Australia) componants refer CoV-2) test to IFU

nasal, N gene (N1 nasopharyng For consumables Becton, Dickinson and ambient and details of US FDA EUA 445003 BD SARS-CoV-2 Reagents 24T/kit BD MAX™ System and N2 see IFU eal and Company temperature componants refer Health Canada/Interim Order regions) oropharynge to IFU al swab

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 1/10 SARS-CoV-2 Nuclear Acid Amplification Technologies

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

For consumables Becton, Dickinson and nasopharyng and details of 444213 BioGX SARS-CoV-2 Reagents 24T/kit BD MAX™ System 6 months 15 to 30°C US FDA EUA Company eal swabs componants refer to IFU

Real-Time Fluorescent RT- QIAamp Virus Applied Biosystems For consumables throat swabs and details of PCR Kit for Detecting SARS- 50T/kit RNA Mini Kit (cat. 7500 Real-Time PCR BGI Genomics Co. Ltd ORF1ab 12 months lower than -18 ºC US FDA EUA or BALF componants refer 2019-nCoV #52904 or 52906). System to IFU

423745 6T/kit For consumables FilmArray® 2.0 and/or the FilmArray® ORF1ab and nasopharyng and details of BioFire® COVID-19 Test BioFire Defense, LLC see IFU 15 to 30°C US FDA EUA Torch Instrument Systems ORF8 eal swabs componants refer 423744 30T/kit to IFU

7500 & 7500 Fast Real- Time PCR System (Applied Biosystems) EMAG® (bioMérieux) QuantStudio12 Flex (QS12) instrument (Applied Biosystems) 30 and For consumables ARGENE® SARS-COV-2 R- 120T/kit N gene and and details of 423735 NucliSENS LightCycler 480 BioMérieux SA see IFU -31 to -15 ºC see IFU US FDA EUA GENE® (depending RdRp gene componants refer easyMAG (System II) on PCR) to IFU (bioMérieux) (Roche)

CFX96 Touch Real- QIASymphony SP Time PCR (QIAgen) Detection System (Bio- Rad)

MagNA Pure 96 Rotor‑Gene Q (Roche) (Qiagen)

ThermoFisher MagMAX™ Viral/Pathogen QX200™ PCR Nucleic Acid Systems Isolation Kit (Cat For consumables 2019-nCoV CDC ddPCR and details of 12008202 200T/kit No. A48310, 1000 BioRad P and N genes see IFU -25 to -15 ºC see IFU US FDA EUA Triplex Probe Assay reactions) componants refer to IFU QIAamp Virus QXDx™ Droplet RNA Mini Kit (cat. Digital™ PCR Systems # 52906)

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 2/10 SARS-CoV-2 Nuclear Acid Amplification Technologies

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

GeneXpert Dx

For consumables US FDA EUA Genes N2 and and details of XPRSARS-COV2-10 Xpert® Xpress SARS-CoV-2 10T/kit GeneXpert Infinity Systems Cepheid see IFU 2 to 28°C see IFU Health Canada/Interim Order E componants refer to IFU TGA GeneXpert Xpress System (Tablet and Hub Configurations)

For consumables VIASURE SARS-CoV-2 Real CerTest Biotec SL / nasopharyng and details of see IFU see IFU TGA Time PCR Detection Kit Abacus dx eal swabs componants refer to IFU

For consumables VIASURE SARS-CoV-2 S gene CerTest Biotec SL / nasopharyng and details of see IFU see IFU TGA Real Time PCR Detection Kit Becton Dickinson eal swabs componants refer to IFU

QIAamp Virus For consumables LOGIX SMART™ Coronavirus CoDx Box (BMS, Bio nasopharyng and details of COVID-K-001 100T/kit RNA Mini Kit Co-Diagnostics, Inc 12 months lower than -20 ºC US FDA EUA Disease 2019 (COVID-19) Kit Molecular Systems) eal swabs componants refer (Qiagen) to IFU

Applied Biosystems™ DC-11-0007 24T/kit QuantStudio 5 Real- nasal swabs, Time PCR Instrument nasopharyng Thermo Fisher For consumables QuantiVirus SARS-CoV-2 Test N, Orf1ab and eal swabs, and details of PureLink™ viral DiaCarta, Inc 12 months -25 to -15 ºC US FDA EUA kit E genes oropharynge componants refer RNA/DNA mini kit DC-11-0008 48T/kit Applied Biosystems™ al swabs, and to IFU 7500 Fast Dx Real- sputum Time PCR Instrument DC-11-0009 480T/kit

For consumables ORF1ab and S and details of US FDA EUA MOL4150 Simplexa™ COVID-19 Direct 24T/kit LIAISON® MDX DiaSorin Molecular see IFU -30 to -10 ºC see IFU gene componants refer Health Canada/Interim Order to IFU

7500 Fast Dx Fast Track Diagnostics NucliSENS® Real-Time PCR For consumables 11416302 (FTD-114- Luxembourg S.á.r.l. (a ORF1ab and N and details of FTD SARS-CoV-2 96T/kit easyMAG® System Instrument see IFU -30 to -10 ºC see IFU US FDA EUA 96) Siemens Healthineers gene componants refer (bioMéreux) (Applied Company) to IFU Biosystems™)

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 3/10 SARS-CoV-2 Nuclear Acid Amplification Technologies

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

PCSYHF02-a 48T/kit 7500 Fast Dx QIAamp DSP Viral Real-Time PCR For consumables Fosun COVID-19 RT-PCR Fosun Pharma USA ORF1ab, and details of RNA Mini Kit Instrument 12 months -25 to -15 ºC see IFU US FDA EUA Detection Kit Inc. N and E genes componants refer (Qiagen) (Applied to IFU PCSYHF03-a 96T/kit Biosystems™)

For consumables EasyScreen™ SARS-CoV-2 Genetic Signatures Ltd N-gene and E- and details of see IFU see IFU see IFU TGA Detection Kit (Australia) gene componants refer to IFU

For consumables ePlex® GenMark Diagnostics, and details of EA008212 12T/kit GenMark ePlex instrument and Software see IFU 2 to 8°C see IFU US FDA EUA SARS-CoV-2 Test Inc componants refer to IFU

96T/kit 7500 Fast Dx Real-Time PCR For consumables QIAamp DSP Viral ORF1ab, and details of GS COVID-19 RT-PCR KIT Instrument GenoSensor LLC see IFU -20°C see IFU US FDA EUA RNA Mini Kit N and E genes componants refer (Applied to IFU 384T/kit Biosystems™)

nasal, QuantStudio™ 3D QIAamp® DSP nasopharyng For consumables COVID-19 RT-Digital PCR Digital and details of CV0202 48T/kit Viral RNA Gnomegen LLC see IFU -10 to -30 ºC eal, and US FDA EUA Detection Kit PCR System (Applied componants refer Mini Kit (Qiagen) oropharynge Biosystems) to IFU al swab ORF1ab For consumables US FDA EUA Panther Fusion SARS-CoV-2 Region 1 and details of PRD-03455 96T/kit Panther System Hologic Inc 2 months 2 to 8°C see IFU Health Canada/Interim Order Kit ORF1ab componants refer TGA Region 2 to IFU KingFisher Flex nucleic acid Applied Biosystems For consumables Ipsum Diagnostics, and details of COV-19 IDx assay 96T/kit extraction QuantStudio12 Flex see IFU see IFU see IFU US FDA EUA LLC componants refer systems QS12 (QS12) instrument to IFU instrument

7500 Fast Dx Real- Time PCR nasopharyng instrument (Applied eal swab, QIAamp® DSP anterior For consumables Smart Detect™ SARS-CoV-2 Biosystems) InBios International, and details of COV2-E 48T/kit Viral RNA see IFU -10 to -30 ºC nasal swab US FDA EUA rRT-PCR Kit Inc componants refer Mini Kit (Qiagen) CFX96 Touch Real- and to IFU Time PCR midturbinate Detection System (Bio- nasal swab Rad)

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 4/10 SARS-CoV-2 Nuclear Acid Amplification Technologies

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

BioRad CFX 96 Touch Total RNA Purification 96- Well Kit For consumables BioRad CFX Connect Curative-Korva SARS-Cov-2 (Norgen Biotek ORF1ab, and details of Real-Time PCR KorvaLabs, Inc. see IFU -20°C see IFU US FDA EUA Assay Corporation) N and E genes componants refer systems manually or using to IFU Tecan Resolvex A200 Roche LightCycler 480 II Real-Time PCR systems

7500 Fast Dx Real- Time PCR nasopharyng instrument (Applied eal swab, QIAamp® DSP anterior For consumables LabGun™ COVID-19 RT-PCR Biosystems) RdRp and N and details of 96T/kit Viral RNA LabGenomics see IFU -25 to -15 ºC nasal swab US FDA EUA Kit genes componants refer Mini Kit (Qiagen) CFX96 Touch Real- and to IFU Time PCR midturbinate Detection System (Bio- nasal swab Rad)

For consumables Life Technologies and details of TaqPath COVID-19 Combo Kit see IFU see IFU see IFU TGA Corporation (USA) componants refer to IFU

For consumables ARIES® SARS-CoV-2 Assay and details of 50-10047 24T/kit Luminex® ARIES® System Luminex Corporation see IFU 15 to 30°C see IFU US FDA EUA Kit componants refer to IFU

bioMérieux® NucliSENS® easyMAG® System Luminex® MAGPIX® ORF1ab, N For consumables NxTAG® CoV Extended Panel Luminex Molecular Store at 2°C to and details of US FDA EUA I054C0463 12T/kit instrument Gene and E see IFU see IFU Assay Diagnostics, Inc. 8°C componants refer Health Canada/Interim Order including xPONENT Gene to IFU bioMérieux® EMAG® System

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 5/10 SARS-CoV-2 Nuclear Acid Amplification Technologies

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

BUSGN7101109 32T/kit Nucleic Acid Extraction Kit, 7500 Real-Time PCR Manual Version For consumables SARS-CoV-2 Fluorescent PCR Systems with v2.3 Maccura Biotechnology ORF1ab, and details of BUSGN7102109 64T/kit or see IFU -30 to -10°C see IFU US FDA EUA Kit software (Applied (USA) LLC N and E genes componants refer Nucleic Acid Biosystems) to IFU Extraction Kit, Fast Version BUSGN7103109 96T/kit

For consumables and details of COV4100 Accula SARS-Cov-2 Test Accula™ Dock or the Silaris™ Dock Mesa Biotech Inc. see IFU 15 to 30°C see IFU US FDA EUA componants refer to IFU

NeuMoDx™ 288 Molecular System Nsp2 target For consumables NeuMoDx™ SARS-CoV-2 Test [500100] or NeuMoDx Molecular, and details of 300800 96T/kit and N gene see IFU 4 to 28°C see IFU US FDA EUA Strip NeuMoDx™ 96 Molecular System Inc. componants refer target [500200] to IFU

Applied Biosystems QIAamp viral RNA 7500 & 7500 Fast Real- Mini Kit Time PCR (Qiagen) System RdRp gene, N For consumables GeneFinder™ COVID-19 Plus OSANG Healthcare and details of US FDA EUA IFMR-45 100T/kit Gene and E see IFU -20 ºC see IFU RealAmp Kit Co., Ltd componants refer Health Canada/Interim Order DNA and Viral NA Gene to IFU Small Volume Kit CFX96 Real-Time PCR (Roche MagNA Instrument (Biorad) Pure 96)

7500 Fast Real-Time PCR System (Applied Biosystems)

Thermo QuantStudio5 Flex Scientific™ (QS5) instrument KingFisher™ Flex (Applied Biosystems) For consumables OPTI SARS-CoV-2 RT PCR OPTI Medical Systems, N gene and and details of 99-57003 LightCycler 480 see IFU -25 to -15°C see IFU US FDA EUA Test Inc. RdRp gene componants refer (System II) to IFU (Roche)

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 6/10 SARS-CoV-2 Nuclear Acid Amplification Technologies

Product codes superscripted with a * (star) mark is WHO prequalified For consumables OPTI SARS-CoV-2 RT PCR OPTI Medical Systems, N gene and and details of 99-57003 see IFU -25 to -15°C see IFU US FDA EUA Anticipated Manufacturer Product ProductTest Name Platform Inc. RdRp gene Recommended componants refer Eligibility Reference detail Manufacturer Detection type Shelf life Specimen type Comments Catalogue number (IVD product) (Extraction and amplification equipement) storage temperature to IFU WHO EUL or others (months)

RealPCR DNA/RNA Agilent Mx3005P™ Magnetic Bead Kit (Agilent) / NucleoMag VET Magnetic Extraction Kit Bio Molecular Systems (IDEXX Mic qPCR (IDEXX Laboratories) Laboratories)

PerkinElmer® Nucleic Acid PerkinElmer® New Extraction Kits Applied Biosystems For consumables US FDA EUA ORF1ab gene and details of 2019-nCoV-PCR-AUS Coronavirus Nucleic Acid 48T/kit (KN0212) and 7500 Real-Time PCR PerkinElmer, Inc. see IFU -25 to -15°C see IFU Health Canada/Interim Order and N gene componants refer Detection Kit PreNAT II System to IFU WHO EUL (SY61)(software version 1.00.06).

Applied Biosystems® 7500 Real-Time PCR System

GXT DNA/RNA Bio-Rad CFX Extraction kit For consumables Z-PATH-COVID-19- COVID-19 genesig® Real- Connect™ and details of 96T/kit (GenoXtract®, Primerdesign Ltd Orf1 ab gene 12 months lower than -20 ºC see IFU WHO EUL CE Time PCR assay Real-Time PCR componants refer Bruker-HAIN Detection to IFU Lifescience GmbH) System

Roche® LightCycler 480 II

Applied Biosystems® 7500 Real-Time PCR System

GXT DNA/RNA Bio-Rad CFX Extraction kit For consumables Z-COVID-19 (US COVID-19 genesig® Real- Connect™ and details of 96T/kit (GenoXtract®, Primerdesign Ltd Orf1 ab gene 12 months lower than -20 ºC see IFU US FDA EUA ONLY) Time PCR assay Real-Time PCR componants refer Bruker-HAIN Detection to IFU Lifescience GmbH) System

Roche® LightCycler 480 II

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 7/10 SARS-CoV-2 Nuclear Acid Amplification Technologies

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

RTA Viral RNA For consumables Extraction Kit as CFX96 Real-Time PCR Procomcure Biotech RdRp gene, E and details of IFMR-45 PhoenixDx® 2019-nCoV 50T/kit see IFU -20 ºC see IFU US FDA EUA extraction Kit (RTA Instrument (Biorad) GmbH Gene componants refer Laboratories) to IFU

Orf1b poly For consumables QIAstat-Dx Respiratory SARS- nasopharyng and details of 691223 6 Tests QIAstat Dx Analyzer System QIAGEN GmbH gene (Rdrp) see IFU 15 to 25°C US FDA EUA CoV-2 Panel eal swab componants refer and E genes to IFU

nasopharyng eal swabs, Roche MagNA Applied Biosystems oropharynge For consumables Quest SARS-CoV-2 rRT-PCR Quest Diagnostics and details of 96T/kit Pure-96 (MP96) 7500 Real Time PCR Gene N1 & N3 12 months -90 to -60°C al swabs, US FDA EUA Kit Infectious Disease Inc componants refer System sputum, to IFU BAL, and tracheal aspirates

Nasopharyng bioMérieux Applied Biosystems For consumables eal or and details of US FDA EUA SKU # CE-M120 Lyra SARS-CoV-2 rRT-PCR Kit 96T/kit NucliSENS 7500 Real Time PCR Quidel Corp. Orf1ab see IFU 2 to 8°C oropharynge componants refer Health Canada/Interim Order easyMAG System al specimens to IFU

nasopharyng For consumables Rheonix COVID-19 MDx eal and and details of KCCOV19-24 96T/kit Rheonix Encompass MDx® Workstation Rheonix ORF1 a/b see IFU see IFU US FDA EUA Assay oropharynge componants refer al swab to IFU

For consumables US FDA EUA Cobas SARS-CoV-2 RT-PCR and details of Health Canada/Interim Order 9175431190 96T/kit cobas 6800/8800 Roche Diagnostics ORF1 a/b see IFU see IFU see IFU Kit componants refer TGA to IFU WHO EUL

QIAamp Virus 24T/kit RNA Mini Kit (cat. Novel Coronavirus (2019- # 52904) Applied Biosystems For consumables nCoV) Nucleic Acid Diagnostic ORF1ab and N and details of S3104E 7500 Real-Time PCR Sansure Bio Tech Inc. see IFU -25 to -15°C see IFU US FDA EUA Kit (PCR-Fluorescence genes componants refer System Probing) to IFU 48T/kit without Extraction

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 8/10 SARS-CoV-2 Nuclear Acid Amplification Technologies

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

ScienCell™ SARS-CoV-2 QIAamp Virus LightCycler® 96 Real- For consumables RdRp gene, N nasopharyng and details of RX7038 Coronavirus Real-time RT- 96T/kit RNA Mini Kit Time PCR System ScienCell 12 months lower than -20 ºC US FDA EUA Gene eal swabs componants refer PCR (RT-qPCR) Detection Kit (Qiagen) (Roche) to IFU

CFX96 Real-Time PCR Instrument (Biorad)

Applied Biosystems QIAamp Virus For consumables STANDARD M nCoV Real- 7500 & 7500 Fast Real- ORF1ab, E and details of M-NCOV-01 96T/kit RNA Mini Kit SD Biosensor see IFU -25 to -15°C see IFU US FDA EUA Time Detection kit Time PCR genes componants refer (Qiagen) System to IFU Roche LightCycler 480 Real-Time PCR systems

CFX96 Real-Time PCR Instrument (Biorad)

QIAamp Virus For consumables U-TOPTM COVID-19 ORF1ab, N and details of SS-9930 96T/kit RNA Mini Kit Seasun Biomaterials see IFU lower than -20 ºC see IFU US FDA EUA Detection Kit Gene componants refer (Qiagen) to IFU Applied Biosystems 7500 & 7500 Fast Real- Time PCR System

Microlab STARlet IVD (Cat. No. CFX96 Real-Time PCR 173000-075, Instrument (Biorad) Hamilton Co.) RdRp gene, N For consumables US FDA EUA and details of RP10250X Allplex™ 2019-nCoV Assay 96T/kit Seegene Inc Gene and E see IFU lower than -20 ºC see IFU Health Canada/Interim Order componants refer STARMag 96 X 4 Gene to IFU TGA Universal CFX96 Touch Real- Cartridge Kit Time PCR Detection (Cat. No. System (Bio-Rad) 744300.4.UC384, Seegene Inc.)

Novel Coronavirus (2019- For consumables Shanghai ZJ Bio-Tech and details of nCoV) Real Time Multiplex RT- see IFU see IFU see IFU TGA Co Ltd (China) componants refer PCR Kit (Detection for 3 genes) to IFU

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 9/10 SARS-CoV-2 Nuclear Acid Amplification Technologies

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

PureLink™ Viral RNA/DNA Mini Not required (RT- For consumables Sherlock CRISPR SARS-CoV-2 Sherlock BioSciences, ORF1ab and N and details of 96T/kit Kit LAMP and CRISPR 12 months lower than -20 ºC see IFU US FDA EUA Kit Inc. genes componants refer (Thermo Fisher Technology used) to IFU Scientific)

SolGent Co., Ltd For consumables DiaPlexQ Novel Coronavirus and details of (represented by JK see IFU see IFU see IFU Health Canada/Interim Order (2019-nCoV) Detection Kit componants refer Toxpert) to IFU

For consumables and details of Spartan Cube CYP2C19 System Spartan Bioscience Inc. see IFU see IFU see IFU Health Canada/Interim Order componants refer to IFU

MagMAX™ Viral/Pathogen Nucleic Acid Applied Biosystems Isolation Kit 7500 & 7500 Fast Real- automated on Time PCR KingFisher™ Flex System Purification System (KingFisher) nasopharyng eal swab, nasopharyng For consumables US FDA EUA Thermo Fisher ORF1ab, S and and details of A47814 TaqPath COVID-19 Combo Kit 1000T/kit see IFU see IFU eal aspirate, Health Canada/Interim Order Scientific Inc N genes componants refer and to IFU TGA bronchoalveo MagMAX™ lar lavage Viral/Pathogen Applied Biosystems™ (BAL) Nucleic Acid QuantStudio 5 Real- Isolation Kit Time PCR Instrument manual (KingFisher)

EasyNat Diagnostic Kit for Novel-Coronavirus (2019- Ustar Biotechnologies For consumables and details of nCoV) RNA (Isothermal (Hangzhou) Co Ltd see IFU see IFU see IFU TGA componants refer Amplification-Real Time (China to IFU Fluorescence Assay 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 SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 10/10