List of SARS-Cov-2 Diagnostic Test Kits and Equipments Eligible For

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Version 33 2021-09-24

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)

The following emergency procedures established by WHO and the Regulatory Authorities of the Founding Members of the GHTF have been identified by the QA Team and will be used to determine eligibility for procurement of COVID-19 diagnostics. The product, to be considered as eligible for procurement with GF resources, shall be listed in one of the below mentioned lists: - WHO Prequalification decisions made as per the Emergency Use Listing (EUL) procedure opened to candidate in vitro diagnostics (IVDs) to detect SARS-CoV-2; - The United States Food and Drug Administration’s (USFDA) general recommendations and procedures applicable to the authorization of the emergency use of certain medical products under sections 564, 564A, and 564B of the Federal Food, Drug, and Cosmetic Act; - The decisions taken based on the Canada’s Minister of Health interim order (IO) to expedite the review of these medical devices, including test kits used to diagnose COVID-19; - The COVID-19 diagnostic tests approved by the Therapeutic Goods Administration (TGA) for inclusion on the Australian Register of Therapeutic Goods (ARTG) on the basis of the Expedited TGA assessment - The COVID-19 diagnostic tests approved by the Ministry of Health, Labour and Welfare after March 2020 with prior scientific review by the PMDA - The COVID-19 diagnostic tests listed on the French government website and under the control of the French Health Authority ANSM

The following websites provide access to Instructions For Use of certain products: - https://extranet.who.int/pqweb/vitro-diagnostics/coronavirus-disease-covid-19-pandemic-%E2%80%94-emergency-use-listing-procedure-eul-open - https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations The following website provides WHO Interim Guidance “Diagnostic testing for SARS-CoV-2”: https://www.who.int/publications/i/item/diagnostic-testing-for-sars-cov-2

Important Note: The following lists are not exhaustive.

SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

QIAamp Viral RNA Mini Kit Light Cycler 480 RNA mini kit (Roche) (QIAgen)

Rotor-Gene Q 5plex HRM (Qiagen)

Applied Biosystems 1DROP INC. (imported For consumables E gene and and details of US FDA EUA 444213 1COPY COVID-19 QPCR KIT 100T/kit Quantstudio5 (Thermo by Luminarie Canada see IFU see IFU see IFU Fisher Scientific) RdRp gene componants refer Health Canada/Interim Order Inc.) to IFU

Applied Biosystems 7500 Real-Time PCR Instrument system (Thermo Fisher Scientific)

CFX96™ Real-Time PCR Detection system (BIO-RAD)

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 1/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

Applied Biosystems Quantstudio3 (Thermo Fisher TRUPCR® Viral Scientific) 3B Blackbio Biotech For consumables RNA RdRp, N and and details of 3B304 TRUPCR SARS-CoV-2 Kit 100T/kit India Ltd (a Kilpest see IFU see IFU see IFU US FDA EUA Extraction Kit E genes componants refer India Ltd company) (3B213V/3B214V) Rotor-Gene Q 5plex to IFU HRM (Qiagen)

Applied Biosystems ANDiS Viral RNA 7500 Real-Time PCR Auto Extraction & Instrument system Purification Kit (Thermo Fisher Scientific)

3D Biomedicine For consumables 3DMed 2019-nCoV RT-qPCR N, E and ORF- and details of 3103010011 100T/kit Automated Nucleic Science & Technology see IFU see IFU see IFU WHO EUL Detection Kit 1ab genes componants refer Acid Extraction Co., Ltd. to IFU System ANDiS 350

Qiagen DSP Viral RNA Mini Kit

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

For consumables US FDA EUA Alinity m SARS-CoV-2 AMP RdRp and N and details of Health Canada/Interim Order 09N78-095 96T/kit Alinity m System Abbott Molecular see IFU see IFU see IFU Kit genes componants refer PMDA to IFU TGA

RdRp and N For consumables genes and and details of US FDA EUA 09N79-096 Alinity m Resp-4-Plex 96T/kit Alinity m System Abbott Molecular see IFU see IFU see IFU Influenza A & componants refer Health Canada/Interim Order B and RSH to IFU

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

For consumables Abbott RealTime SARS-CoV-2 RdRp and N and details of 09N77-095 96T/kit Abbott m2000 Abbott Molecular see IFU see IFU see IFU US FDA EUA RT-PCR Kit genes componants refer to IFU

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 2/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

Accelerate For consumables Resolute 2.0 SARS CoV-2 and details of see IFU see IFU Technologies Pte Ltd see IFU see IFU see IFU see IFU TGA Detection Kit componants refer (DxD Hub) to IFU

NucliSENS® easyMAG® (bioMérieux) For consumables 13279F 960T/kit N gene, ORF-1 MassARRAY® SARS-CoV-2 and details of 13278D 3840T/kit MassARRAY System Agena Bioscience, Inc. and ORF-1ab see IFU see IFU see IFU US FDA EUA componants refer Panel 768T/kit 13281D gene to IFU KingFisher Flex Purification System (ThermoFisher)

CFX96™ Touch Real- Time PCR Detection System (Bio-Rad) AltoStar® For consumables RealStar® SARS-CoV-2 RT- Altona Diagnostics and details of 821025 384T/kit Automation see IFU see IFU 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

AMT Pte Ltd RESOLUTE 2.0 TGA (Singapore)

NucliSENS® easyMAG® (bioMérieux) For consumables BioCode® MDx-3000 and details of 64-C0304 BioCode® SARS-CoV-2 Assay 384T/kit Applied BioCode Inc N gene see IFU see IFU see IFU US FDA EUA automated system componants refer to IFU MagNA Pure 96 (Roche)

QIAamp® Viral Applied Biosystems DX-1001-001-000 100T/kit RNA Mini Kit QuantStudio™ Dx Real- (Qiagen) Time PCR system

For consumables Applied Biosystems TRIzol™ RNA and details of QuantStudio 5 Real- Extraction Kit componants refer Time PCR (Invitrogen) to IFU System DX-1001-002-000 500T/kit Linea™ COVID-19 Real-Time Note: See WHO Applied DNA Sciences S genes 6 months see IFU see IFU US FDA EUA PCR Assay Kit assay kit Information Notice for IVD users 2021/01 with

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to regards to Board Decision GF/B42/EDP11 3/65 mutations in SARS- CoV-2 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included) For consumables and details of Platform Platform Anticipated Manufacturer Product Product Name Recommended componants refer Eligibility criteria Reference detail (Extraction (amplification Manufacturer Detection type Shelf life Specimen type Comments Catalogue number (IVD product) storage temperature to IFU WHO EUL or others equipment) equipement) (months) DX-1001-002-000 500T/kit Linea™ COVID-19 Real-Time Note: See WHO Applied DNA Sciences S genes 6 months see IFU see IFU US FDA EUA PCR Assay Kit assay kit Mag-Bind Viral Information Notice RNA Xpress Kit for IVD users (Omega Bio-Tek) 2021/01 with regards to Applied Biosystems mutations in SARS- Mag-Bind Viral 7500 Fast Real-Time CoV-2 RNA Xpress Kit PCR (Omega Bio-Tek) System DX-1001-003-000 1000T/kit automated on the Hamilton STARlet system

For consumables Arkray Factory Co., and details of Identity Pack SARS-CoV-2 see IFU see IFU see IFU PMDA Ltd. componants refer to IFU

CFX96 Real-Time System (Bio-Rad)

Roche LightCycler 480 Instrument II Real- Time PCR System N gene and For consumables iAMP® COVID-19 Detection and details of iAMP-COVID19-100 100T/kit not required Atila BioSystems, Inc. the ORF-1ab 12 months see IFU see IFU US FDA EUA Kit componants refer Atila gene to IFU PowerGene 9600 Plus Real-Time PCR System

Applied Biosystems 7500 Fast Real-Time PCR System

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

N gene (N1 For consumables Becton, Dickinson and and details of US FDA EUA 445003-01 BD SARS-CoV-2 Reagents 24T/kit BD MAX™ System and N2 see IFU see IFU see IFU Company componants refer Health Canada/Interim Order regions) to IFU

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 4/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

N gene (N1 and N2 For consumables Becton, Dickinson and and details of 445011 BD SARS-CoV-2/Flu Reagents 24T/kit BD MAX™ System regions) and see IFU see IFU see IFU US FDA EUA Company componants refer Influenza A / to IFU Influenza B

N gene (N1 For consumables Becton, Dickinson and nasopharyng and details of 444213 BioGX SARS-CoV-2 Reagents 24T/kit BD MAX™ System and N2 6 months see IFU US FDA EUA Company eal swabs componants refer regions) to IFU

TIANamp Virus Applied Biosystems RNA extraction Kit 7500/7500 Fast Real- (DP315-R) Time PCR TIANGEN System

Applied Biosystems QIAamp Virus QuantStudio 5 Real- RNA Mini Kit (cat. Time PCR #52904). For consumables Real-Time Fluorescent RT- Systems and details of MFG030011 PCR Kit for Detecting SARS- 50T/kit BGI Europe A/S ORF1ab 6 months see IFU see IFU WHO EUL componants refer 2019-nCoV RNA extraction kit to IFU by MGI Tech SLAN-96P PCR (Wuhan) system (No.20200167)

LightCycler® 480

System

BGI Europe A/S Real-Time Fluorescent RT- (distributed by BGI PCR Kit for Detecting SARS- TGA Health (AU) Company Cov-2 (2 gene) Pty Ltd)

Real-Time Fluorescent RT- QIAamp Virus Applied Biosystems For consumables 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 see IFU see IFU US FDA EUA componants refer 2019-nCoV #52904 or 52906). System to IFU

Nucleic acid Applied Biosystems extraction Kit 7500 Real-Time PCR (XABT, Cat. # System CN8033)

QIAamp Viral RNA CFX96 Touch Real- Mini Kit (Qiagen, Time PCR Cat. # 52904 or Detection System (Bio- 52906) Rad) Beijing Applied ORF1ab and N For consumables Multiple Real-Time PCR Kit and details of CT8233-48T 48T/kit Biological Technologies gene and the E see IFU see IFU see IFU WHO EUL for Detection of 2019-nCoV componants refer Co. Ltd., (XABT) gene to IFU

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 5/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

Platform Platform Anticipated Manufacturer Product Product Name Recommended Eligibility criteria Reference detail (Extraction (amplification Manufacturer Detection type Shelf life Specimen type Comments Catalogue number (IVD product) storage temperature WHO EUL or others equipment) equipement) Beijing Applied ORF1ab and N (months) For consumables Multiple Real-Time PCR Kit and details of CT8233-48T 48T/kit Biological Technologies gene and the E see IFU see IFU see IFU WHO EUL for Detection of 2019-nCoV componants refer PURELINK VIRAL Co. Ltd., (XABT) gene to IFU LightCycler 480 RNA/DNA KIT (System II) (Invitrogen, Cat. (Roche) #12280050)

High Pure Viral RNA Kit (Roche, Cat. # 11858882001)

Beijing Wantai Applied Biosystem® Nucleic Acid 7500 Extraction Kit Real-Time PCR system (cat. # ZCT1246)

Beijing Wantai CFX96 Touch Real- Nucleic Acid Time PCR Extraction Kit on Detection System (Bio- KingFisher Flex 96 Rad) (ThermoFisher)

Beijing Wantai Beijing Wantai Wantai SARS-CoV-2 RT-PCR Nucleic Acid ORF1ab and N WS-1248 48T/kit Biological Pharmacy see IFU see IFU see IFU See IFU WHO EUL Kit Extraction Kit on gene NEXOR 32 (Yantai Enterprise Co., Ltd Addcare Bio-Tec)

Beijing Wantai Nucleic Acid Extraction Kit on NEXOR 96 (Yantai Addcare Bio-Tec)

QIAamp Viral RNA Mini Kit QIAGEN (cat. # 52094)

Applied Biosystems Veriti Thermal Cycler and For consumables Applied Biosystems Sars-Cov-2 and details of qSanger-COVID-19 Assay 3072T/kit BillionToOne, Inc see IFU see IFU see IFU US FDA EUA 3730xl DNA Analyzer Genome componants refer and to IFU Thermo Fisher (Invitrogen) DynaMag-96 Side Magnet

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 6/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

Applied Biosystems 7500 Real-Time PCR System

CFX96 Touch Real- Time PCR Detection System (Bio- QIAamp DSP Viral For consumables Rad) BC-01-0099 BioCore 2019-nCoV Real Time 100T/kit RNA Mini Kit N gene and and details of US FDA EUA BioCore Co. Ltd. see IFU see IFU see IFU BC-01-0099 x4 PCR Kit 400T/kit (Qiagen; catalog RdRp gene componants refer TGA #61904) to IFU

SLAN-96P (Shanghai Hongshi Medical Technology Co. Ltd)

LightCycler 96 (Roche)

CFX96 Touch Real- For consumables BS-SY-SC2-100 Bio-Speedy® Direct RT-qPCR 100T/kit Time PCR Bioeksen R&D and details of ORF1ab gene see IFU see IFU see IFU US FDA EUA BS-SY-SC2-1000 SARS-CoV-2 1000T/kit Detection System (Bio- Technologies Ltd componants refer Rad) to IFU

Rotor‑Gene Q (Qiagen)

LightCycler 96 (Roche)

Bio-Speedy® Direct RT-qPCR CFX96 Touch Real- Bioeksen R&D For consumables BS-SY-SC2-100 SARS-CoV-2 100T/kit Time PCR Technologies Ltd and details of ORF1ab gene see IFU see IFU see IFU US FDA EUA BS-SY-SC2-1000 rebranded to 1000T/kit Detection System (Bio- (distributed by componants refer BioeXsen SARS-CoV-2 RT PCR Rad) BioeXsen GmbH) to IFU

Rotor‑Gene Q (Qiagen)

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 7/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

LightCycler 96 (Roche)

RINA M14 Nucleic CFX96 Touch Real- For consumables BS-SY-WCOR-304- Bio-Speedy® Direct RT-qPCR Acid Extraction Time PCR Bioeksen R&D and details of 100T/kit ORF1ab gene see IFU see IFU see IFU WHO EUL 100 SARS-CoV-2 Robot (Cat No: Detection System (Bio- Technologies Ltd componants refer RINA-M14-01) Rad) to IFU

Rotor-Gene Q 5plex (Qiagen)

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 see IFU US FDA EUA Torch Instrument Systems ORF8 eal swabs componants refer 423744 30T/kit to IFU

For consumables (US FDA EUA replaced by Biofire Respiratory Panel 2.1 FilmArray® 2.0 and/or the FilmArray® BioFire Diagnostics and details of DeNovo approval) 423738 see IFU see IFU see IFU see IFU (RP2.1) Torch Instrument Systems LLC componants refer Health Canada/Interim Order to IFU TGA

S Gene, M For consumables Biofire Respiratory Panel 2.1- BioFire Diagnostics Gene, and details of 423883 FilmArray® 2.0 EZ Systems see IFU see IFU see IFU US FDA EUA EZ (RP2.1-EZ) LLC Influenza A componants refer and others to IFU

Applied Biosystems n/a QuantStudio 5

Applied Biosystems 7500 Fast Dx For consumables BioGX Xfree COVID-19 Direct and details of 500-003-XMP 104T/kit BioGX, Inc. N gene see IFU see IFU see IFU US FDA EUA RT-PCR componants refer to IFU Bio-Rad CFX96 Touch

Bio-Rad CFX384 Touch

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 8/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

MagMax Viral/Pathogen on KingFisher Flex Bio-Rad CFX96 Purification System For consumables Biomeme SARS-CoV-2 Real- ORF1ab and S and details of US FDA EUA 96T/kit (ThermoFisher) Biomeme Inc. see IFU see IFU see IFU Time RT-PCR gene componants refer to IFU Biomeme M1 Sample Prep QuantStudio 5 Cartridge Kit for RNA 2.0

For consumables Biomeme SARS-CoV-2 Go- Biomeme’s Franklin Real-Time PCR ORF1ab and S and details of US FDA 3000555 Biomeme Inc. see IFU see IFU see IFU Strips System gene componants refer Health Canada/Interim Order 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 US FDA EUA 423735 NucliSENS LightCycler 480 BioMérieux SA see IFU see IFU see IFU GENE® (depending RdRp gene componants refer Health Canada/Interim Order 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)

For consumables and details of SARS-COV-2 R-GENE® BioMérieux SA see IFU see IFU see IFU see IFU TGA componants refer to IFU

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 9/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

ThermoFisher MagMAX™ Viral/Pathogen QX200™ PCR Nucleic Acid Systems Isolation Kit (Cat No. A48310, 1000 reactions)

QIAamp Virus RNA Mini Kit (cat. For consumables Bio-Rad SARS-CoV-2 ddPCR Bio-Rad Laboratories and details of 12013743 200T/kit # 52906) P and N genes see IFU see IFU see IFU US FDA EUA Kit Inc componants refer to IFU ThermoFisher MagMAX™ Viral/Pathogen Nucleic Acid QXDx™ Droplet Isolation Kit (Cat Digital™ PCR Systems No. A48310, 1000 reactions) on KingFisher Flex system

QIAamp Virus CFX Opus Real-Time RNA Mini Kit (cat. PCR (Biorad) # 52906)

CFX96 Touch (Biorad)

P and N genes Bio-Rad Reliance SARS-CoV- For consumables Bio-Rad Laboratories and and details of 12015361 2/FluA/FluB RT-PCR Assay 200T/kit see IFU see IFU see IFU US FDA EUA Inc Influenza A/ componants refer Kit CFX96 Dx (Biorad) Influenza B to IFU

Applied Biosystems 7500 Fast Dx Real‑Time PCR System

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 10/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

7500 Real-Time PCR System (Applied Biosystems)

7500 Fast Real-Time PCR System (Applied Biosystems) MagNA Pure 96 For consumables Real-Q 2019-nCoV Detection (Roche) E gene and and details of BS7nCoV 100T/kit QuantStudio5 realtime BioSewoom see IFU see IFU see IFU US FDA EUA Kit RdRp gene componants refer PCR instrument or manual to IFU (Applied Biosystems)

CFX96 DX Real-Time PCR Detection System (Bio- Rad)

CFX96 Real-Time PCR Detection System (Bio- Rad)

7500 Real-Time PCR RNeasy Mini kit System (Applied (Qiagen) Biosystems)

7500 Fast Real-Time For consumables PCR RdRp gene and details of TD1100 COVID-19 RT-PCR PNA kit 24T/kit BioTNS see IFU see IFU see IFU US FDA EUA System (Applied and N genes componants refer Biosystems) to IFU

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

For consumables US FDA EUA GeneXpert Xpress System (Tablet and Hub Genes N2 and see IFU (302- see IFU (302- and details of XPRSARS-COV2-10 Xpert® Xpress SARS-CoV-2 10T/kit Cepheid see IFU Health Canada/Interim Order Configurations) E 3750) 3750) componants refer to IFU TGA

GeneXpert Dx For consumables US FDA EUA Genes N2 and see IFU (302- see IFU (302- and details of Health Canada/Interim Order XPRSARS-COV2-10 Xpert® Xpress SARS-CoV-2 10T/kit Cepheid see IFU E 3562) 3562) componants refer TGA GeneXpert Infinity Systems to IFU WHO EUL

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 11/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

Genes N2 and E and For consumables XPCOV2/FLU/RSV- Xpert Xpress SARS-CoV- GeneXpert Xpress System (Tablet and Hub see IFU (302- see IFU (302- and details of US FDA EUA 10T/kit Cepheid Influenza see IFU 10 2/Flu/RSV Configurations) 4419) 4419) componants refer TGA A/Influenza to IFU B/RSV RNA

RdRp and Genes N and E For consumables XP3COV2/FLU/RSV- Xpert Xpress CoV-2/Flu/RSV GeneXpert Xpress System (Tablet and Hub see IFU (302- see IFU (302- and details of 10T/kit Cepheid and Influenza see IFU US FDA EUA 10 plus Configurations) 6991) 6991) componants refer A/Influenza to IFU B/RSV RNA

GeneXpert Dx Genes N2 and E and For consumables XPCOV2/FLU/RSV- Xpert Xpress SARS-CoV- see IFU (302- see IFU (302- and details of US FDA EUA 10T/kit Cepheid Influenza see IFU 10 2/Flu/RSV 4421) 4421) componants refer TGA GeneXpert Infinity Systems A/Influenza to IFU B/RSV RNA

For consumables Genes N2 and and details of OMNISARS-COV2-10 Xpert® Omni SARS-CoV-2 10T/kit GeneXpert Omni System Cepheid see IFU see IFU see IFU US FDA EUA E componants refer to IFU

For consumables VIASURE SARS-CoV-2 Real CerTest Biotec SL / ORF1ab and N nasopharyng and details of see IFU see IFU TGA Time PCR Detection Kit Abacus dx gene 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 Dickensen eal swabs componants refer to IFU

Thermo 7500 Real-Time PCR Scientific™ System (Applied KingFisher™ Flex Biosystems)

CFX96 Touch Real- For consumables Bioer GenePure Time PCR Chaozhou Hybribio ORF1ab and N and details of TGA HBRT-COVID-19 COVID-19 Real-Time PCR Kit 24T/kit Pro Nucleic Acid see IFU see IFU see IFU Detection System (Bio- Biochemistry Ltd. genes componants refer WHO EUL Purification System Rad) to IFU

96S Real-Time PCR System (SLAN)

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 12/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

Clear Dx™ system comprising Hamilton STAR robotic platform For consumables Sars-Cov-2 and details of Clear Dx™ SARS-CoV-2 Test 192T/kit and Clear Labs, Inc see IFU see IFU see IFU US FDA EUA Genome componants refer Oxford Nanopore GridION Sequencer to IFU and ALPAQUA Magnum FLX on deck magnet

QIAamp Viral RNA ABI QuantStudio 6 Mini Kit Flex

Maxwell RSC Viral Total Nucleic Acid Multi-Pack Kitwith RdRp gene For consumables Clinomics TrioDx RT-PCR and details of TR-US-01 100T/kit the Maxwell RSC Clinomics USA Inc. and N and E see IFU see IFU see IFU US FDA EUA COVID-19 Test componants refer 48 instrument genes to IFU

MagMAX Viral/Pathogen II Nucleic Acid Isolation Kit with KingFisher Flex instrument

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

For consumables DirectDetect™ SARS-CoV-2 Coyote Bioscience Co and details of see IFU see IFU see IFU TGA Detection Kit Ltd (China) componants refer to IFU

CTK Biotech Inc For consumables Aridia COVID-19 Real-Time and details of (United States Of see IFU see IFU see IFU TGA PCR Test componants refer America) to IFU

For consumables and details of US FDA EUA C1020 Cue COVID-19 Test Cue Health Monitoring System Cue Health Inc N Gene see IFU see IFU see IFU componants refer Health Canada/Interim Order to IFU

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 13/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

7500 Fast Real-Time PCR System (Applied Thermo Biosystems) Scientific™ KingFisher™ Flex QuantStudio7 (Fast Block) instrument For consumables (Applied Biosystems) N gene (N1 and details of 99-57003 HDPCR™ SARS-CoV-2 Assay 480T/kit ChromaCode, Inc. and N2 see IFU see IFU see IFU US FDA EUA componants refer regions) QuantStudio 12k Flex to IFU (96-well Fast Block) instrument (Applied Roche MagNA Biosystems) Pure-24 Bio Molecular Systems Mic qPCR (IDEXX Laboratories)

YHXB No. Applied Biosystems™ 20170583, 7500 Dx Real-Time YHXB No. Detection Kit for 2019 Novel PCR Instrument For consumables DA0930 24T/kit 20150302 (DAAN) Da An Gene Co., Ltd. Coronavirus (2019-nCoV) ORF1ab and N and details of WHO EUL DA0931 48T/kit of Sun Yat-sen 12 months see IFU see IFU componants refer RNA, (PCR- Fluorescence 96T/kit genes TGA DA0932 University to IFU Probing) QIAamp Viral Roche LightCycler480 RNA Mini Kit, Ⅱ 52906

For consumables and details of QuickNavi-Flu+COVID19 Ag Denka Co., Ltd. see IFU see IFU see IFU PMDA componants refer to IFU

For consumables MobileDetect-BIO BCC19 Test and details of MOL4150 24T/kit MD-Bio BCC19 Heater DetectaChem LLC N and E genes see IFU see IFU see IFU US FDA EUA Kit componants refer 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 see IFU see IFU US FDA EUA kit E genes oropharynge componants refer DC-11-0008 48T/kit RNA/DNA mini kit to IFU Applied Biosystems™ al swabs, and 7500 Fast Dx Real- sputum Time PCR Instrument DC-11-0009 480T/kit

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 14/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

Thermo Fisher Applied Biosystems™ DC-11-0017 24T/kit PureLink™ viral QuantStudio 5 Real- RNA/DNA mini kit Time PCR Instrument nasal swabs, nasopharyng For consumables QuantiVirus SARS-CoV-2 eal swabs, and details of Applied Biosystems™ DiaCarta, Inc Orf1ab genes 12 months see IFU US FDA EUA Mulitplex Test kit MGI MGISP960 oropharynge componants refer DC-11-0018 48T/kit 7500 Fast Dx Real- to IFU High Throughput al swabs, and Time PCR Instrument Automated Sample sputum Preparation System Bio-Rad CXF 384 Real- DC-11-0019 480T/kit Time PCR Instrument

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

Loopamp New Coronavirus For consumables Eiken Chemical Co., Replicase 1B and details of LMP401 2019 (SARS-CoV-2) Detection 48T/kit see IFU see IFU see IFU see IFU PMDA Ltd. region componants refer Reagent Kit to IFU

GENFLEX platform V1.0

N gene (N1 For consumables AMPIPROBE® SARS-CoV-2 QIAsymphony® and details of ENZ-GEN215-0096 Enzo Life Sciences, Inc. and N2 see IFU see IFU see IFU US FDA EUA Assay kit SP (QIAGEN) componants refer regions) QuantStudio® 5 Real- to IFU Time PCR System (Applied Biosystems) Manual

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 15/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

QIAamp Virus LightCycler® 480 II MP 2606-0125 25T/kit RNA Mini Kit (Roche) (Qiagen)

7500 Fast Dx Prepito Viral DNA- Real-Time PCR MP 2606-0225 50T/kit RNA200 Kit Instrument (Chemagen) (Applied Biosystems™) CFX96 Touch Real- Chemagic Viral Time PCR MP 2606-0425 100T/kit DNA/RNA 300 Kit Detection System (Bio- H96 EUROIMMUN For consumables Rad) Health Canada/Interim Order Medizinische ORF1ab and N and details of EURORealTime SARS-CoV-2 see IFU see IFU see IFU US FDA EUA Labordiagnostika AG gene componants refer TGA (Germany) to IFU qTOWER3 MP 2606-0100 100T/kit (Analytik Jena)

MP 2606-0200 200T/kit

MP 2606-1000 1000T/kit

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

11416300 (FTD-114- 32T/kit 7500 Fast Dx 32) Fast Track Diagnostics NucliSENS® Real-Time PCR For consumables Luxembourg S.á.r.l. (a ORF1ab and N and details of FTD SARS-CoV-2 easyMAG® System Instrument see IFU see IFU see IFU WHO EUL Siemens Healthineers gene componants refer (bioMéreux) (Applied 11416284 (FTD-114- Company) to IFU 96T/kit Biosystems™) 96)

Biomark HD in Conjunction with Juno or IFC Controller RX For consumables Advanta Dx SARS-CoV-2 RT- and details of 102-0355 with Fluidigm Corporation N-gene see IFU see IFU see IFU US FDA EUA PCR Assay componants refer Applied Biosystems Veriti 96-Well Thermal to IFU Cycler

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 16/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

QIAamp QuantStudio™ DX DSP Viral RNA (Applied Biosystems) Mini Kit (Qiagen)

CFX96 Touch Real- QIAamp Time PCR Viral RNA Mini Kit Detection System (Bio- (Qiagen) Rad) For consumables N-gene and E- and details of CV002 GenePro SARS-CoV-2 Test Gencurix, Inc. see IFU see IFU see IFU US FDA EUA gene componants refer MagMAX™ to IFU Viral/Pathogen Nucleic Acid Isolation Kit automated on KingFisher™ Flex Purification System (KingFisher)

7500 Fast Dx QIAamp Real-Time PCR For consumables NeoPlex COVID-19 Detection RdRp and N and details of 96T/kit DSP Viral RNA Instrument GeneMatrix, Inc. see IFU see IFU see IFU US FDA EUA Kit gene componants refer Mini Kit (Qiagen) (Applied to IFU Biosystems™)

QIAamp QIAGEN Rotor- For consumables GB SARS-CoV-2 Real Time RT- General Biologicals ORF1ab and E and details of 4PCO052E 100T/kit DSP Viral RNA Gene® Q real-time see IFU see IFU see IFU TGA PCR Corp gene componants refer Mini Kit (Qiagen) PCR cycler to IFU

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

7500 Fast Dx QIAamp Real-Time PCR For consumables RPQ021 Genetron SARS-CoV-2 RNA 50T/kit Genetron Health ORF1ab and N and details of DSP Viral RNA Instrument 6 months see IFU see IFU US FDA EUA RPQ022 Test 100T/kit (Beijing) Co., Ltd. gene componants refer Mini Kit (Qiagen) (Applied to IFU Biosystems™)

Sars-Cov-2 For consumables ePlex Respiratory Pathogen GenMark Diagnostics, and other and details of EA001222 12T/kit GenMark ePlex instrument and Software see IFU see IFU see IFU US FDA EUA Panel 2 (ePlex RP2 Panel) Inc pathogenic componants refer RNA to IFU

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

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 17/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

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 see IFU 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 see IFU eal, and US FDA EUA Detection Kit PCR System (Applied componants refer Mini Kit (Qiagen) oropharynge Biosystems) to IFU al swab For consumables Procleix Panther System with Procleix Grifols Diagnostic and details of Procleix SARS-CoV-2 Assay 250T/kit see IFU see IFU see IFU US FDA EUA Reagent Preparation Incubator 250 Solutions Inc componants refer to IFU

RT-PCR IVD MEDICAL ORF1ab DEVICE FOR 2019 NOVEL For consumables Region 1 and details of NAT-01 CORONAVIRUS (SARS-COV- see IFU see IFU HA TECH PTY LTD see IFU see IFU see IFU TGA ORF1ab componants refer 2) NUCLEIC ACID Region 2 to IFU DETECTION

ORF1ab For consumables US FDA EUA Region 1 and details of PRD-06419 Aptima SARS-CoV-2 assay 250T/kit Panther System Hologic Inc see IFU see IFU see IFU TGA ORF1ab componants refer PMDA Region 2 to IFU

ORF1ab For consumables US FDA EUA Panther Fusion SARS-CoV-2 Region 1 and details of 96T/kit Panther/Panther Fusion System Hologic Inc see IFU see IFU see IFU Health Canada Interim Order Kit ORF1ab componants refer TGA Region 2 to IFU

ORF1ab Region 1 For consumables and details of US FDA EUA PRD-06815 Aptima SARS-CoV-2/Flu assay 250T/kit Panther System Hologic Inc ORF1ab see IFU see IFU see IFU componants refer Health Canada Interim Order Region 2 to IFU Influenza A/B

7500 Dx Real-Time PCR Instrument (Applied Biosystems™) For consumables and details of 351251 Hymon™ SARS-CoV-2 Test Kit 96T/kit HymonBio Co. LTD N and E genes see IFU see IFU see IFU US FDA EUA componants refer to IFU QuantStudio 5 RT PCR System (Applied Biosystems™)

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 18/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

For consumables and details of BKit Virus Finder Covid-19 Hyris Ltd. see IFU see IFU see IFU Health Canada/Interim Order componants refer to IFU

NovaSeq 6000 Sequencing System

NextSeq 500 Sequencing System For consumables Health Canada/Interim Order Sars-Cov-2 and details of see IFU Illumina® COVIDSeq™ Test 3072T/kit Illumina see IFU see IFU see IFU US FDA EUA Genome componants refer to IFU PMDA NextSeq 550 Sequencing System

NextSeq 550Dx Sequencing System

7500 Fast Dx Real- Time PCR instrument (Applied QIAamp® DSP Biosystems) Viral RNA Mini Kit (Qiagen) CFX96 Touch Real- Time PCR Detection System (Bio- For consumables Smart Detect™ SARS-CoV-2 InBios International, ORF1b, and details of COV2-E 48T/kit Rad) see IFU see IFU see IFU US FDA EUA rRT-PCR Kit Inc N and E genes componants refer MagMAX to IFU Viral/Pathogen II Nucleic Acid CFX384 Touch Isolation Kit Real-Time PCR Hamilton MagEx Detection System (Bio- Star automated Rad) liquid handling system

For consumables Smart Detect™ SARS-CoV-2 InBios International, and details of COV2-C see IFU see IFU see IFU Health Canada/Interim Order rRT-PCR Kit Inc componants refer to IFU

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 19/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

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

Viral nucleic acid Applied Biosystems isolation kit QuantStudio5 (Bioperfectus instrument Technologies) Jiangsu Bioperfectus For consumables US FDA EUA JC10223-1NW-50T COVID-19 Coronavirus Real 50T/kit ORF1ab and N and details of Technologies Co Ltd see IFU see IFU see IFU TGA JC10223-1NW-25T Time PCR Kit 25T/kit genes componants refer (China) WHO EUL QIAamp® Viral 7500 Real-Time PCR to IFU RNA instrument (Applied Mini Kit (Qiagen) Biosystems)

Novel Coronavirus (SARS-CoV- 24T/kit 7500 Real-Time PCR For consumables Jiangsu CoWin Biotech ORF1ab and N and details of 2) Fast Nucleic Acid Detection 48T/kit see IFU instrument (Applied see IFU see IFU see IFU US FDA EUA Co., Ltd. (China) genes componants refer Kit 96T/kit Biosystems) to IFU

For consumables KANEKA Direct RT-PCR kit KANEKA and details of see IFU see IFU see IFU PMDA SARS-CoV-2 CORPORATION componants refer to IFU

For consumables and details of SmartAmp SARS-CoV-2 K.K. DNAFORM see IFU see IFU see IFU PMDA componants refer to IFU

QIAamp Virus StepOne/StepOnePlus For consumables KimForest SARS-CoV-2 KimForest Enterprise and details of KF2019CoV01 96T/kit RNA Mini Kit Real-Time PCR RdRp genes see IFU see IFU see IFU US FDA EUA Detection Kit v1 Co., Ltd. componants refer (Qiagen) Systems (Applied to IFU Biosystems)

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 20/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

CFX96 Real-Time PCR Detection System (Bio- Rad)

For consumables QIAamp® DSP 7500 Real-Time PCR PowerChek™ 2019-nCoV Real- Kogene Biotech Co Ltd RdRp and E and details of US FDA EUA R6900TD Viral RNA Mini Kit instrument (Applied see IFU see IFU see IFU time PCR Kit (Korea - Republic of) genes componants refer TGA (QIAGEN) Biosystems) to IFU

7500 Fast Real-Time PCR instrument (Applied Biosystems)

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

Biosearch Technologies SARS- For consumables CoV-2 IntelliQube PCR LGC Biosearch and details of 96T/kit see IFU see IFU see IFU US FDA EUA Real-Time and End-Point RT- System Technologies componants refer PCRTest to IFU

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

For consumables Lucira COVID-19 All-In-One and details of US FDA EUA 810055970056 24T/kit Disposable Lucira Device Lucira Health, Inc. N genes see IFU see IFU see IFU Test Kit componants refer Health Canada/Interim Order to IFU

For consumables ARIES® SARS-CoV-2 Assay and details of US FDA EUA 50-10047 24T/kit Luminex® ARIES® System Luminex Corporation see IFU see IFU see IFU Kit componants refer Health Canada/Interim Order to IFU

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 21/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

bioMérieux® NucliSENS® easyMAG® System Luminex® MAGPIX® ORF1ab, N For consumables NxTAG® CoV Extended Panel Luminex Molecular and details of US FDA EUA I054C0463 96T/kit instrument Gene and E see IFU see IFU see IFU Assay Diagnostics, Inc. componants refer Health Canada/Interim Order including xPONENT Gene to IFU bioMérieux® EMAG® System

bioMérieux® ORF1ab, N NucliSENS® Gene and E easyMAG® System Luminex® MAGPIX® For consumables NxTAG Respiratory Pathogen Luminex Molecular Gene and and details of I056C0468 96T/kit instrument see IFU see IFU see IFU US FDA EUA Panel + SARS-CoV-2 Diagnostics, Inc. Influenza A & componants refer including xPONENT B and RSH to IFU bioMérieux® and others EMAG® System

Luminultra For consumables Genecount Covid-19 Rt-Qpcr and details of GCRNA-COVID-96R Technologies Ltd. see IFU see IFU see IFU Health Canada/Interim Order Assay Kit componants refer (Canada) to IFU

Qiagen DSP Virus/Pathogen Kit Roche LightCycler 480 on QIAsymphony II SP (Qiagen)

MagMax Viral/Pathogen Applied Biosystems Nucleic Acid 7500 Fast Isolation Kit Dx (Applied For consumables LumiraDx SARS-CoV-2 RNA Biosystem) and details of L018180030096 LumiraDx UK Ltd ORF1a Gene see IFU see IFU see IFU US FDA EUA STAR componants refer QIAamp Viral Applied Biosystems to IFU RNA Mini Kit QuantStudio 5 (Qiagen)

Agilent AriaMx RT- PCR Instruments

Agilent Stratagene Mx3005P RT-PCR Instruments

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 22/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

Applied Biosystems 7500 Fast Dx

Applied Biosystems QuantStudio 5

Applied Biosystems QuantStudio 7 Flex

For consumables LumiraDx SARS-CoV-2 RNA Roche LightCycler 480 and details of L018180130096 n/a LumiraDx UK Ltd ORF1a Gene see IFU see IFU see IFU US FDA EUA STAR Complete II componants refer to IFU

Bio-Rad CFX96 Touch Real-Time PCR Detection System

Agilent AriaMx RT- PCR Instruments

Agilent Stratagene Mx3005P RT-PCR Instruments

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

QIAGEN QIAamp BUSGN7103109 96T/kit Viral RNA Mini Kit

EZ1 Virus Mini Kit v2.0 on EZ1 Advanced 7500 Fast Dx Real- For consumables SARS-CoV-2 DETECTR Mammoth Biosciences, RP and N and details of benchtop Time PCR Instrument see IFU see IFU see IFU US FDA EUA Reagent Kit Inc. Gene componants refer automated (Applied Biosystems) to IFU extraction instrument (Qiagen)

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 23/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

Materials and For consumables MatMaCorp COVID-19 2SF Machines Corporation and details of ST-CV19-2SF MatMaCorp Solas 8 Instrument RdRp gene see IFU see IFU see IFU US FDA EUA Test of America (DBA componants refer MatmaCorp, Inc.) to IFU

For consumables Medical & Biological and details of MEBRIGHT SARS-CoV-2 Kit see IFU see IFU see IFU PMDA Laboratories Co., Ltd. componants refer to IFU

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

For consumables 7K105 Veri-Q PCR 316 COVID-19 50 test/kit ORF3a and N and details of TGA Veri-Q System MiCoBioMed Co Ltd see IFU see IFU see IFU 7K111 Detection Kit 100 test/kit gene target componants refer WHO EUL to IFU

For consumables and details of Smart Gene SARS-CoV-2 Mizuhomedy Co., Ltd. see IFU see IFU see IFU PMDA componants refer to IFU

For consumables MobileDetect Bio BCC19 (MD- E and N gene and details of 12T/kit MD-Bio heater MobileDetect Bio Inc. see IFU see IFU see IFU US FDA EUA Bio BCC19) Test Kit target componants refer to IFU

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

Nsp2 target NeuMoDx™ 288 Molecular System and N gene For consumables NeuMoDx Flu A-B/RSV/SARS- [500100] or NeuMoDx Molecular, target and and details of 300800 96T/kit see IFU see IFU see IFU US FDA EUA CoV-2 Vantage Assay NeuMoDx™ 96 Molecular System Inc. Influenza A/B componants refer [500200] and RSV M to IFU genes

TAN Bead® Applied Biosystems extract system 7500 & 7500 Fast Real- (Taiwan Advanced Time PCR For consumables Nanotech) System Ningbo Health Gene Sars-Cov-2 Virus Detection ORF1ab, and details of Health Canada/Interim Order XC25073 50T/kit Technologies Co., Ltd see IFU see IFU see IFU Diagnostic Kit N and S genes componants refer WHO EUL (China) to IFU RNeasy Mini Kit (Qiagen)

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 24/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

For consumables DXTM67120 2019-NCoV Taqman Rt-PCR Norgen Biotek Corp. RdRp and E and details of see IFU see IFU see IFU Health Canada/Interim Order (500RXNS) Kit Dx (Canada) Gene componants refer to IFU

For consumables DXTM67100 2019-NCoV Taqman Rt-PCR Norgen Biotek Corp. RdRp and E and details of see IFU see IFU see IFU Health Canada/Interim Order (50RXNS) Kit Dx (Canada) Gene componants refer to IFU

For consumables COVID-19 Taqman Rt-PCR Kit Norgen Biotek Corp. RdRp and E and details of DXTM67200 see IFU see IFU see IFU Health Canada/Interim Order (e/rdrp Genes) Dx (Canada) Gene componants refer to IFU

7500 Fast Real-Time PCR System (Applied Biosystems) QIAsymphony DSP For consumables QuantStudio5 Flex Virus/Pathogen Kit OPTOLANE RdRp and E and details of RDM101-X Kaira 2019-nCoV Detection Kit 100T/kit (QS5) instrument see IFU see IFU see IFU US FDA EUA on Technologies, Inc. Gene componants refer (Applied Biosystems) QIAsymphony SP to IFU (Qiagen)

CFX96 Real-Time PCR Instrument (Biorad)

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 see IFU 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)

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 25/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

7500 Fast Real-Time PCR System (Applied Biosystems)

Duo instrument QuantStudio5 Flex (Thermo Scientific) (QS5) instrument (Applied Biosystems) For consumables 99-57003 OPTI SARS-CoV-2 RT PCR OPTI Medical Systems, N gene and and details of LightCycler 480 see IFU see IFU see IFU US FDA EUA 99-57004 Test Inc. RdRp gene componants refer (System II) to IFU (Roche)

Agilent Mx3005P™ (Agilent) Flex instrument (Thermo Scientific) Bio Molecular Systems Mic qPCR (IDEXX Laboratories)

see For consumables P23 Labs TaqPath SARS-CoV-2 and details of see IFU ThermoFisher TaqPath COVID-19 P23 Labs, LLC see IFU see IFU see IFU see IFU US FDA EUA Assay componants refer Combo Kit to IFU

For consumables MiniAmp A37834 and details of DetectX-Rv see IFU PathogenDx, Inc. see IFU see IFU see IFU see IFU US FDA EUA (ThermoFisher) componants refer to IFU

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 26/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

PerkinElmer® Nucleic Acid Extraction Kits Applied Biosystems (KN0212) and 7500 Real-Time PCR PreNAT II System (SY61)(software version 1.00.06).

chemagic™ Viral DNA/RNA 300 Kit special H96 (CMG- 1033, CMG-1033- Applied Biosystems™ S) 7500 Fast Dx Real- and chemagic™ Time PCR System 360 (2024-0020) with chemagic™ Rod Head Set 96 (CMG371) PerkinElmer® New PerkinElmer, Inc. / For consumables US FDA EUA ORF1ab gene and details of 2019-nCoV-PCR-AUS Coronavirus Nucleic Acid 48T/kit Suzhou Sym-Bio see IFU see IFU see IFU Health Canada/Interim Order and N gene componants refer Detection Kit Lifescience Co Ltd to IFU WHO EUL Applied Biosystems™ QuantStudio 3 Real- Time PCR System

Applied Biosystems™ QuantStudio 5 Real- Time PCR System

Analytik Jena qTower3 / qTower3G Real- Time PCR System

Analytik Jena qTower3 84 / qTower3 84 G Real-Time PCR System

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 27/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

Thermo Fisher MiniAmp Thermal cycler with

IntelliPlexTM 1000 πCode Processor For consumables IntelliPlex SARS-CoV-2 QIAmp Viral RNA RdRp gene, N and details of 82303-U 96T/kit (PlexBio; Cat. PlexBio Co., Ltd. 12 months see IFU see IFU US FDA EUA Detection Kit Mini Kit (Qiagen) and E Gene componants refer No. 80033) to IFU and PlexBio 100 Fluorescent Analyzer (PlexBio; Cat. No. 80000)

For consumables FastPlex Triplex SARS-CoV-2 QIAmp Viral RNA DropX-2000 Digital RdRp gene nasopharyng and details of 02.01.1019 24T/kit PreciGenome LLC see IFU see IFU US FDA EUA detection kit Mini Kit (Qiagen) PCR System and N Gene eal swab componants refer to IFU

For consumables Triplelock SARS-Cov-2 Test Precision nasopharyng and details of see IFU see IFU Health Canada/Interim Order Strips Biomonitoring Inc eal swab componants refer to IFU

For consumables ELITe MGB SARS-CoV-2 PCR Precision System and details of see IFU see IFU see IFU PMDA Detection Kit Science Co., Ltd. componants refer to IFU

Applied Biosystems® 7500 Real-Time PCR System GXT DNA/RNA Extraction kit For consumables Z-PATH-COVID-19- COVID-19 genesig® Real- Bio-Rad CFX and details of WHO EUL 96T/kit (GenoXtract®, Primerdesign Ltd Orf1 ab gene 12 months see IFU see IFU CE Time PCR assay Connect™ componants refer TGA Bruker-HAIN Real-Time PCR to IFU Lifescience GmbH) Detection System Roche® LightCycler 480 II

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 28/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

Applied Biosystems® 7500 Real-Time PCR GXT DNA/RNA System Extraction kit (GenoXtract®, For consumables Z-COVID-19 (US COVID-19 genesig® Real- Bio-Rad CFX and details of 96T/kit Bruker-HAIN Primerdesign Ltd Orf1 ab gene 12 months see IFU see IFU US FDA EUA ONLY) Time PCR assay Lifescience GmbH) Connect™ componants refer Real-Time PCR to IFU Detection System QIAamp Viral RNA Roche® LightCycler Mini kit 480 II

7500 Fast Real-Time PCR System (Applied RTA Viral RNA Biosystems) Extraction Kit as extraction Kit (RTA Laboratories) CFX96 Touch Real- Time PCR Detection System (Bio- Procomcure Biotech For consumables GmbH (Trax E gene and and details of PCCSKU15261 PhoenixDx® 2019-nCoV 50T/kit Rad) see IFU see IFU see IFU US FDA EUA Management Services RdRp gene componants refer Inc.) to IFU QIAamp MinElute Rotor‑Gene Q Virus Spin Kit (Qiagen) (Qiagen)

High Pure Viral RNA Kit (Roche)

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 29/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

RTA Viral RNA 7500 Fast Real-Time Extraction Kit as PCR extraction Kit (RTA System (Applied Laboratories) Biosystems)

MagMax CFX96 Touch Real- Viral/Pathogen Time PCR Nucleic Acid Detection System (Bio- Isolation Kit Rad) (Thermo Fisher)

QIAamp MinElute Rotor‑Gene Q Virus Spin Kit (Qiagen) (Qiagen)

High Pure Viral DTPrime5 RNA Kit (Roche) (DNA Technologie)

SphaeraMag DNA/RNA qTower3G Isolation Kit (Analytik Jena) (Procomcure) Procomcure Biotech For consumables PhoenixDx® SARS-CoV-2 GmbH (Trax ORF1ab and details of PCCSKU15262 50T/kit see IFU see IFU see IFU US FDA EUA Multiplex Applied Biosystems™ Management Services and N genes componants refer QuantStudio 1 Real- Inc.) to IFU Time PCR Instrument (ThermoFisher)

Applied Biosystems™ QuantStudio 3 Real- Time PCR Instrument (ThermoFisher)

Applied Biosystems™ QuantStudio 5 Real- Time PCR Instrument (ThermoFisher)

Applied Biosystems™ QuantStudio 7 Real- Time PCR Instrument (ThermoFisher)

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 30/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

Orf1b poly For consumables US FDA EUA QIAstat-Dx Respiratory SARS- nasopharyng and details of 691223 6 Tests QIAstat Dx Analyzer System QIAGEN GmbH gene (Rdrp) see IFU see IFU Health Canada/Interim Order CoV-2 Panel eal swab componants refer and E genes to IFU TGA

CFX96 Touch Real- Time Detection System (Biorad)

For consumables #1110 with #1105 Quick-RNA Viral CFX384 Touch Real- Quadrant Biosciences saliva swab and details of Clarifi COVID-19 Test Kit 480T/kit RdRp genes see IFU see IFU US FDA EUA #1154 with #1155 96 Kit Time Detection Inc. specimen componants refer System (Biorad) to IFU

QuantStudio 5 instrument (Applied Biosystems)

Roche MagNA Pure-96 (MP96)

Mag-Bind Viral Applied Biosystems For consumables Quest SARS-CoV-2 rRT-PCR RNA Xpress Kit Quest Diagnostics and details of 39433 96T/kit 7500 Real Time PCR Gene N1 & N3 12 months see IFU see IFU US FDA EUA Kit (Omega Bio-Tek, Infectious Disease Inc componants refer System Cat. M6219-2304) to IFU with the MagEx STAR (Hamilton)

For consumables Quest Diagnostics RC COVID- Quest Diagnostics and details of 96T/kit cobas 6800/8800 (Roche) Gene N1 & N3 12 months see IFU see IFU US FDA EUA 19 +Flu RT-PCR Infectious Disease Inc componants refer to IFU

Quest Diagnostics Self-Collection Kit for COVID-19 Quest Diagnostics RC SARS- Quest Diagnostics 96T/kit cobas 6800/8800 (Roche) ORF1 a/b 12 months see IFU see IFU For consumables US FDA EUA CoV-2 rRT-PCR Kit Infectious Disease Inc and details of componants refer to IFU

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 31/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

nasopharyng Quest Diagnostics eal swabs, ORF1ab Self-Collection Kit oropharynge for COVID-19 Quest Diagnostics HA SARS- Quest Diagnostics Region 1 96T/kit Aptima (Hologic) 12 months see IFU al swabs, For consumables US FDA EUA CoV-2 rRT-PCR Kit Infectious Disease Inc ORF1ab sputum, and details of Region 2 BAL, and componants refer tracheal to IFU aspirates

nasopharyng Quest Diagnostics eal swabs, ORF1ab Self-Collection Kit oropharynge for COVID-19 Quest Diagnostics PF SARS- Quest Diagnostics Region 1 96T/kit Panther Fusion (Hologic) 12 months see IFU al swabs, For consumables US FDA EUA CoV-2 rRT-PCR Kit Infectious Disease Inc ORF1ab sputum, and details of Region 2 BAL, and componants refer tracheal to IFU aspirates

bioMérieux Applied Biosystems NucliSENS 7500 Real Time PCR easyMAG System

Applied Biosystems 7500 Fast Dx Real‑Time PCR System Nasopharyng For consumables eal or and details of US FDA EUA SKU # CE-M120 Lyra SARS-CoV-2 rRT-PCR Kit 96T/kit Roche Quidel Corp. Orf1ab see IFU see IFU componants refer LightCycler 480 oropharynge Health Canada Interim Order al specimens to IFU

Qiagen Rotor-Gene Q

Bio-Rad CFX96 Touch

Thermofisher QuantStudio 7 Pro

Nasopharyng For consumables eal or and details of US FDA EUA M313 Solana SARS-CoV-2 Assay 96T/kit Solana Instrument Quidel Corp. Orf1ab see IFU see IFU oropharynge componants refer Health Canada Interim Order al specimens to IFU

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 32/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

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 09175431190 Cobas SARS-CoV-2 RT-PCR 192T/kit and details of Health Canada/Interim Order cobas 6800/8800 Roche Diagnostics ORF1 a/b see IFU see IFU see IFU 09343733190 Kit 480T/kit componants refer PMDA to IFU WHO EUL

ORF1 a/b and nucleocapsid protein gene with matrix For consumables US FDA EUA cobas SARS-CoV-2 & Influenza Roche Molecular gene of and details of Health Canada/Interim Order 09233474190 96T/kit cobas 6800/8800 see IFU see IFU see IFU A/B Nucleic Acid Test Systems, Inc. Influenza A, componants refer PMDA and non- to IFU TGA structural protein gene of Influenza B

ORF1 a/b and nucleocapsid protein gene with matrix For consumables US FDA EUA cobas SARS-CoV-2 & Influenza Roche Molecular gene of and details of 09211101190 20T/kit cobas Liat System see IFU see IFU see IFU Health Canada/Interim Order A/B Nucleic Acid Test Systems, Inc. Influenza A, componants refer PMDA and non- to IFU structural protein gene of Influenza B

QIAamp Virus 24T/kit RNA Mini Kit (cat. Novel Coronavirus (2019- # 52904) Applied Biosystems For consumables US FDA EUA nCoV) Nucleic Acid Diagnostic ORF1ab and N and details of S3104E 7500 Real-Time PCR Sansure Bio Tech Inc. see IFU see IFU see IFU Health Canada/Interim Order Kit (PCR-Fluorescence genes componants refer System TGA 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 33/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

Viral RNA ScienCell™ SARS-CoV-2 Isolation Kit Coronavirus Real-time RT- (ScienCell) LightCycler® 96 Real- For consumables RX7038 RdRp gene, N and details of PCR (RT-qPCR) Detection Kit 96T/kit Time PCR System ScienCell see IFU see IFU see IFU US FDA EUA (RX7048) Gene componants refer (Multiplex option) (Roche) QIAamp Virus to IFU RNA Mini Kit (Qiagen)

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 see IFU 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 RNA Mini Kit (Qiagen) Applied Biosystems 7500 & 7500 Fast Real- Time PCR System For consumables U-TOP™ COVID-19 Detection PANAMAX Viral ORF1ab and N and details of US FDA EUA SS-9930 96T/kit Seasun Biomaterials see IFU see IFU see IFU Kit DNA/RNA Gene componants refer Health Canada/Interim Order Extraction Kit to IFU performed on the PANAMAX 48 Nucleic Acid Extraction System

TOP Viral DNA/RNA Extraction Kit

CFX96 Real-Time PCR Instrument (Biorad) For consumables AQ-TOP COVID-19 Rapid QIAamp DSP Virus ORF1ab and N and details of SS-9920 96T/kit Seasun Biomaterials see IFU see IFU see IFU US FDA EUA Detection Kit Kit (Qiagen) Gene componants refer Applied Biosystems to IFU 7500 Real-Time PCR System

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 34/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

CFX96 Real-Time PCR Instrument (Biorad) QIAamp DSP Virus Kit (Qiagen) Applied Biosystems 7500 Real-Time PCR System For consumables AQ-TOP COVID-19 Rapid ORF1ab and N and details of SS-9940 96T/kit PANAMAX Viral Seasun Biomaterials see IFU see IFU see IFU US FDA EUA Detection Kit PLUS DNA/RNA Gene componants refer Extraction Kit to IFU performed on the PANAMAX 48 Nucleic Acid Extraction System

TOP Viral DNA/RNA Extraction Kit

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 35/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

Microlab STARlet IVD (Cat. No. CFX96 Real-Time PCR 173000-075, Instrument (Biorad) Hamilton Co.)

STARMag 96 X 4 Universal Cartridge Kit (Cat. No. CFX96 Touch Real- 744300.4.UC384, Time PCR Detection Seegene Inc.) using System (Bio-Rad) Microlab NIMBUS IVD instrument (Microlab)

QIAamp DSP Viral Applied Biosystems Mini Kit using 7500 & 7500 Fast Dx QIAcube Real-Time PCR instrument System (QIAgen)

RdRp gene, N For consumables RP10243X / 100T/kit Ribospin vRD Viral and details of Allplex™ 2019-nCoV Assay kit Seegene Inc Gene and E see IFU see IFU see IFU US FDA EUA RP10252W 124T/kit RNA/DNA componants refer Extraction Kit Gene to IFU (GeneAll) (manual)

MagMAX Viral/Pathogen Nucleic Acid Isolation Kit using KingFisher Flex instrument

MagNA Pure DNA and Viral NA Small Volume Kit using Roche MagNA Pure 96

AdvanSure NA EX Kit (extraction kit) using AdvanSure E3 Instrument System (LG Chem)

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 36/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

RdRp gene, N For consumables Allplex™ SARS-CoV- Gene and E and details of see IFU Seegene Inc see IFU see IFU see IFU TGA 2/FluA/FluB/RSV Assay Gene and componants refer Influenza A/B to IFU

PCSYHF02-a 48T/kit 7500 Fast Dx QIAamp DSP Viral Real-Time PCR Shanghai Fosun Long For consumables Fosun COVID-19 RT-PCR ORF1ab, and details of RNA Mini Kit Instrument March Medical Science 12 months see IFU see IFU US FDA EUA Detection Kit N and E genes componants refer (Qiagen) (Applied Co Ltd (China) to IFU PCSYHF03-a 96T/kit Biosystems™)

Novel Coronavirus (2019- Shanghai Fosun Long For consumables nCoV) RT-PCR Detection Kit ORF1ab, and details of PCSYHF March Medical Science see IFU see IFU see IFU WHO EUL (commercial name: Fosun N and E genes componants refer Co Ltd (China) 2019-nCoV qPCR) to IFU

GenAct NE-48 (Shanghai 7500 Novel Coronavirus 2019-nCoV GeneoDx) Real-Time PCR Shanghai GeneoDx For consumables ORF1ab and and details of GZ-D2RM25 Nucleic Acid Detection Kit 50T/kit Instrument Biotechnology Co., Ltd see IFU see IFU see IFU WHO EUL N genes componants refer (Real-time PCR) QIAamp DSP Viral (Applied (China) to IFU RNA Mini Kit Biosystems™) (Qiagen)

Applied Biosystems 7500 Real-Time PCR System nucleic acid extraction product ORF1ab and N For consumables Diagnostic kit for SARS-CoV-2 and equipment of CFX96 Real-Time PCR Shanghai Kehua bio- and details of KH-G-M-574-48 48T/kit genes and E 12 months see IFU see IFU WHO EUL Nucleic acid (Real-time PCR) Shanghai Kehua Instrument (Biorad) engineering Co., Ltd componants refer genes bio-engineering to IFU Co., Ltd

Tianlong Gentier 96E

Applied Biosystems Novel Coronavirus (2019- QIAamp Virus ORF1ab and N For consumables 7500 & 7500 Fast Real- Shanghai ZJ Bio-Tech and details of RR-0485-02 nCoV) Real Time Multiplex RT- 25T/kit RNA Mini Kit genes and E see IFU see IFU see IFU WHO EUL Time PCR Co Ltd (China) componants refer PCR Kit (Qiagen) genes System to IFU

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 37/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

nucleic acid extraction product and equipment of ABI Prism 7500 Shanghai ZJ Bio- Tech

QIAamp Virus CFX96 Real-Time PCR RNA Mini Kit Instrument (Biorad) (Qiagen) Novel Coronavirus (2019- ORF1ab and N For consumables Shanghai ZJ Bio-Tech and details of RR-0479-02 nCoV) Real Time Multiplex RT- 25T/kit genes and E see IFU see IFU see IFU TGA Co Ltd (China) componants refer PCR Kit (Detection for 3 genes) genes to IFU

SLAN

MIC POC Dx48

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 see IFU see IFU US FDA EUA Kit Inc. genes componants refer (Thermo Fisher Technology used) to IFU Scientific) For consumables Ampdirect 2019-nCoV and details of Shimadzu Corporation see IFU see IFU see IFU PMDA detection kit componants refer to IFU

QIAamp Virus CFX96 Real-Time PCR RNA Mini Kit Instrument (Biorad) (Qiagen) For consumables SML GENETREE Co., RdRP and N and details of GNT2011-1 Ezplex SARS-CoV-2 G Kit 100T/kit see IFU see IFU see IFU US FDA EUA Ltd. genes componants refer Applied Biosystems to IFU 7500 Real-Time PCR System

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 Spartan COVID-19 System Test Spartan Bioscience Inc. and details of ASM-00144 see IFU Spartan COVID-19 System see IFU see IFU see IFU see IFU Health Canada/Interim Order Cartridge (Canada) componants refer to IFU

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 38/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

For consumables SpeeDx Pty Ltd and details of PlexPCR® SARS-CoV-2 see IFU see IFU see IFU TGA (Australia) componants refer to IFU

Suzhou Sym-Bio For consumables PerkinElmer® SARS-CoV-2 Lifescience Co Ltd and details of see IFU see IFU see IFU TGA Real-time RT-PCR Assay (China) (represented componants refer by PerkinElmer) to IFU

2019-nCoV Fluorescence For consumables and details of Detection Real-time RT-PCR Sysmex Corporation see IFU see IFU see IFU PMDA componants refer Kit to IFU

For consumables and details of 80-10284 T2SARS-CoV-2 Panel 12T/kit T2Dx® Instrument T2 Biosystems, Inc. see IFU see IFU see IFU US FDA EUA componants refer to IFU

For consumables Takara SARS-CoV-2 Direct and details of Takara Bio Inc. see IFU see IFU see IFU PMDA PCR detection kit componants refer to IFU

QIAamp Virus Applied Biosystems RNA Mini Kit 7500 Real-Time PCR (Qiagen) System

For consumables ExProbeTM SARS-CoV-2 TBG Biotechnology RdRp gene, N and details of 68020 see IFU see IFU see IFU US FDA EUA Testing Kit EZbead Viral Corp and E genes componants refer Extraction Kit with to IFU TBG Q6000 Real- automated EZbead Time PCR System System-32 instrument

PGA4102P1 (liquid) / SARS-CoV-2 Nucleic acid For consumables PGA4102P2 detection kit based on Real- and details of Tellgen Corporation see IFU see IFU see IFU WHO EUL (lyophilized Time PCR componants refer form) platform to IFU

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 39/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

MagMAX™ Viral/Pathogen Nucleic Acid Applied Biosystems Isolation Kit 7500 & 7500 Fast Real- (manual) and Time PCR automated on System KingFisher™ Flex Purification System (KingFisher) For consumables TaqPath COVID-19 Combo Kit Thermo Fisher ORF1ab, S and and details of A47813 200T/kit see IFU see IFU see IFU US FDA EUA Advanced Scientific Inc N genes componants refer to IFU MagMAX™ Applied Biosystems™ Viral/Pathogen II QuantStudio 5 Real- Nucleic Acid Time PCR Instrument Isolation Kit (manual) and automated on KingFisher™ Flex Applied Biosystems™ Purification System QuantStudio 7 Flex (KingFisher) Real-Time PCR Instrument

MagMAX™ Viral/Pathogen Nucleic Acid Applied Biosystems Isolation Kit 7500 & 7500 Fast Real- (manual) and Time PCR automated on System KingFisher™ Flex Purification System (KingFisher) Thermo Fisher Scientific Inc For consumables ORF1ab, S and and details of A47814 TaqPath COVID-19 Combo Kit 1000T/kit (see also Life see IFU see IFU see IFU US FDA EUA N genes componants refer Technologies to IFU MagMAX™ Applied Biosystems™ Corporation) Viral/Pathogen II QuantStudio 5 Real- Nucleic Acid Time PCR Instrument Isolation Kit (manual) and automated on KingFisher™ Flex Applied Biosystems™ Purification System QuantStudio 7 Flex (KingFisher) Real-Time PCR Instrument

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 40/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

Applied Biosystems 7500 Fast Real-Time PCR System

Thermo Fisher Scientific Inc For consumables TaqPath COVID-19, FluA, FluB ORF1ab, S and and details of A49868 1000T/kit (see also Life see IFU see IFU see IFU US FDA EUA Combo Kit N genes componants refer Technologies to IFU MagMAX™ Applied Biosystems™ Corporation) Viral/Pathogen II QuantStudio 5 Real- Nucleic Acid Time PCR Instrument Isolation Kit (manual) and automated on KingFisher™ Flex Purification System (KingFisher)

For consumables Thermo Fisher and details of A47817 Taqpath COVID-19 Rt-PCR Kit see IFU see IFU see IFU Health Canada/Interim Order Scientific Inc componants refer to IFU

Thermo Fisher TaqPath New Coronavirus Scientific Inc For consumables and details of (SARS-CoV-2) Real-Time PCR (see also Life see IFU see IFU see IFU PMDA componants refer Detection Kit Technologies to IFU Corporation)

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 41/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

MagMAX™ Viral/Pathogen Nucleic Acid Applied Biosystems Isolation Kit 7500 & 7500 Fast & (manual) and Fast Dx Real-Time automated on PCR KingFisher™ Flex System Purification System (KingFisher) For consumables TaqPath COVID-19 CE-IVD RT- Thermo Fisher ORF1ab, S and and details of A48067 1000T/kit see IFU see IFU see IFU WHO EUL PCR Kit Scientific Inc N genes componants refer MagMAX™ Applied Biosystems™ to IFU Viral/Pathogen II QuantStudio 5 & 5 Dx Nucleic Acid Real-Time PCR Isolation Kit Instrument (manual) and automated on KingFisher™ Flex Applied Biosystems™ Purification System QuantStudio 7 Flex (KingFisher) Real-Time PCR Instrument

MagMAX™ Viral/Pathogen Nucleic Acid Applied Biosystems™ Isolation Kit QuantStudio 7 Flex (manual) and Real-Time PCR automated on Instrument KingFisher™ Flex Purification System Thermo Fisher (KingFisher) Scientific Inc For consumables TaqPath™ COVID-19 Pooling ORF1ab, S and and details of A49918 384T/kit (see also Life see IFU see IFU see IFU US FDA EUA Kit N genes componants refer Technologies MagMAX™ to IFU Corporation) Viral/Pathogen II Nucleic Acid Isolation Kit (manual) and automated on KingFisher™ Flex Purification System (KingFisher)

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 42/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

MagMAX™ Viral/Pathogen II Nucleic Acid Applied Biosystems™ Isolation Kit QuantStudio 5 Flex (manual) and Real-Time PCR automated on Instrument KingFisher™ Flex Thermo Fisher Purification System Scientific Inc For consumables TaqPath COVID-19 RNase P ORF1ab and N and details of A51333 1T/kit (KingFisher) (see also Life see IFU see IFU see IFU US FDA EUA Combo Kit 2.0 genes componants refer Technologies to IFU Corporation)

Applied Biosystems™ QuantStudio 7 Flex Real-Time PCR Instrument

Applied Biosystems™ QuantStudio 5 Flex n/a Real-Time PCR Instrument Thermo Fisher Scientific Inc For consumables TaqPath COVID-19 FAST PCR ORF1ab and N and details of A51606 1T/kit (see also Life see IFU see IFU see IFU US FDA EUA Combo Kit 2.0 genes componants refer Technologies to IFU Corporation)

Applied Biosystems™ QuantStudio 7 Flex Real-Time PCR Instrument

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 43/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

Applied Biosystems™ QuantStudio 5 Flex n/a Real-Time PCR Instrument Thermo Fisher Scientific Inc For consumables TaqPath™ ORF1ab and N and details of A51329 1T/kit (see also Life see IFU see IFU see IFU US FDA EUA COVID‑19 MS2 Combo Kit 2.0 genes componants refer Technologies to IFU Corporation)

Applied Biosystems™ QuantStudio 7 Flex Real-Time PCR Instrument

Amplitude™ Thermo Fisher Solution Applied Biosystems™ Amplitude™ Solution with Scientific Inc For consumables automated on a QuantStudio 7 Flex ORF1ab, S and and details of US FDA EUA A49869 TaqPath COVID-19 High 20000/kit (see also Life see IFU see IFU see IFU Tecan™ Fluent™ Real-Time PCR N genes componants refer Health Canada/Interim Order Throughput Combo Kit Technologies 1080 Automation Instrument to IFU Corporation) Workstation

Applied Biosystems 7500 & 7500 Fast Real- Time PCR For consumables System RNeasy Mini kit RdRp and N and details of TD1100 COVID-19 RT-PCR PNA Kit 100T/kit TNS Co., Ltd (Bio TNS) see IFU see IFU see IFU US FDA EUA (Qiagen) genes componants refer CFX96 Touch Real- to IFU Time PCR Detection System (Bio- Rad)

For consumables TRCReadyR-80 and Chipset for TRCRR and details of TRCReady SARS-CoV-2 Tosoh Corporation see IFU see IFU see IFU PMDA detection reagent componants refer to IFU

For consumables QIAmp Viral RNA and details of Gene Cube SARS-CoV-2 48T/kit Toyobo Co., Ltd. N genes see IFU see IFU see IFU PMDA Mini Kit (Qiagen) componants refer to IFU

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 44/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

NextSeq 500 Sequencing System

For consumables Twist Bioscience Sars-Cov-2 and details of 102997 SARS-CoV-2 NGS Assay 96T/kit see IFU see IFU see IFU US FDA EUA Corporation Genome componants refer to IFU NextSeq 550 Sequencing System

NextSeq 550Dx Sequencing System

Diagnostic Kit for Novel- Ustar Biotechnologies For consumables Coronavirus (2019-nCoV) RNA and details of (Hangzhou) Co Ltd see IFU see IFU see IFU TGA (Isothermal Amplification-Real componants refer (China) Time Fluorescence Assay to IFU

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

Sentosa® SA201 Real- Time PCR Instrument For consumables ViroKey™ SARS-CoV-2 RT- Vela Operations Orf1a and and details of US FDA EUA 300681 4x50T/kit see IFU see IFU see IFU see IFU PCR Test Singapore Pte Ltd RdRp componants refer TGA Applied Biosystems® to IFU 7500 Fast Dx Real- Time PCR System

Sentosa® SA201 Real- Time PCR Instrument For consumables ViroKey™ SARS-CoV-2 RT- Vela Operations Orf1a and and details of 301068 8x48T/kit see IFU see IFU see IFU see IFU US FDA EUA PCR Test v2.0 Singapore Pte Ltd RdRp componants refer Applied Biosystems® to IFU 7500 Fast Dx Real- Time PCR System

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 45/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

For consumables Visby Medical COVID-19 Point and details of PS-001541 1T/kit n/a Visby Medical see IFU see IFU see IFU US FDA EUA of Care Test componants refer to IFU

For consumables SARS-CoV-2 RT-qPCR and details of Wallac Oy (Finland) see IFU see IFU see IFU TGA Reagent Kit componants refer to IFU

Wuhan EasyDiagnosis For consumables COVID-19 (SARS-CoV-2) and details of Biomedicine Co Ltd see IFU see IFU see IFU TGA Nucleic Acid Test kit componants refer (China) to IFU

Virus RNA Applied Biosystems™ Extraction Kit QuantStudio 3 real- (Xiamen Zeesan) time PCR

For consumables SARS-CoV-2 Test Kit (Real- Xiamen Zeesan Biotech ORF1ab and N and details of 801301 48T/kit Lab-Aid Virus RNA see IFU see IFU see IFU US FDA EUA time PCR) Extraction Kit Co., Ltd. (China) genes componants refer on to IFU Bio-Rad CFX96 Real- Lab-Aid 824s Time System Nucleic Acid Extraction System

QIAamp Virus Applied Biosystems® RNA Mini Kit 7500 Fast Real-Time (Qiagen) PCR System

For consumables SC-COVID19-20 COVID-19 Nucleic Acid RT- 20T/kit MagMAX™ ZhuHai Sinochips ORF1ab and N and details of see IFU see IFU see IFU US FDA EUA SC-COVID19-100 PCR Test Kit 100T/kit Viral/Pathogen Bioscience Co., Ltd genes componants refer Nucleic Acid to IFU Applied Biosystems® Isolation Kit 7500 Fast Dx Real- automated on Time PCR System KingFisher™ Flex Purification System (KingFisher)

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 46/65 SARS-CoV-2 Nucleic Acid Amplification Technologies (only sequencing equipment with the intended use to diagnoses acute infections are included)

MagMAX™ Viral/Pathogen Nucleic Acid Bio-Rad CFX96 Touch Isolation Kit Real-Time PCR automated on Detection System KingFisher™ Flex Purification System (KingFisher)

R3011 For consumables Quick SARS-CoV-2 rRT-PCR and details of US FDA EUA R3011-1K Zymo Research Corp N genes see IFU see IFU see IFU Kit componants refer Health Canada/Interim Order R3011-10K to IFU MagMAX™ Viral/Pathogen Applied Biosystems™ Nucleic Acid QuantStudio 5 Real- Isolation Kit Time PCR Instrument manual (KingFisher)

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 47/65 Version 33 2021-09-24

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)

A new technology for COVID-19 detection has become available that is much simpler and faster to perform than currently-recommended nucleic acid amplification tests (NAAT), like PCR. This method relies on direct detection of SARS-CoV-2 viral proteins in nasal swabs and other respiratory secretions using a lateral flow immunoassay (also called an RDT) that gives results in < 30 minutes. Though these antigen detection RDTs (Ag-RDTs) are substantially less sensitive than NAAT, they offer the possibility of rapid, inexpensive and early detection of the most infectious COVID-19 cases in appropriate settings. For more detailed technical advise please consult the WHO Interim guidance available at: https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays

SARS-CoV-2 Antigen Rapid Diagnostic Tests

Anticipated Manufacturer Product Product Name Number of tests Platform Recommended Eligibility Manufacturer Analyte Shelf life Specimen type Comments Catalogue number (IVD product) per kit (Calibrator and Equipment) storage temperature WHO EUL or others (months)

SARS-CoV-2 Abbott Diagnostics nucleocapsid 195-000 BinaxNOW COVID-19 Ag Card 40T/kit n/a see IFU see IFU see IFU Visual read US FDA EUA Scarborough, Inc. protein antigen

SARS-CoV-2 BinaxNOW COVID-19 Ag 2 Abbott Diagnostics nucleocapsid 195-005 40T/kit n/a see IFU see IFU see IFU Visual read US FDA EUA Card Scarborough, Inc. protein antigen

SARS-CoV-2 Panbio COVID-19 Ag Rapid Abbott Rapid Health Canada/Interim Order 41FK10 nucleocapsid Test Device 25T/kit n/a Diagnostics Jena see IFU see IFU see IFU Visual read TGA 41FK20 protein (NASOPHARYNGEAL) GmbH WHO EUL antigen

SARS-CoV-2 Abbott Rapid Health Canada/Interim Order 41FK11 Panbio COVID-19 Ag Rapid nucleocapsid 25T/kit n/a Diagnostics Jena see IFU see IFU see IFU Visual read TGA 41FK21 Test Device (NASAL) protein GmbH WHO EUL antigen

SARS-CoV-2 Alfresa Pharma nucleocapsid Arsonic COVID-19 Ag n/a see IFU see IFU see IFU PMDA Corporation protein antigen

SARS-CoV-2 ARISTA™ COVID-19 Antigen Arista Biotech Pte Ltd nucleocapsid n/a see IFU see IFU see IFU Visual read TGA Rapid Test (Singapore) protein antigen

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 48/65 SARS-CoV-2 Antigen Rapid Diagnostic Tests

SARS-CoV-2 Assure Tech COVID-19 Antigen Rapid Test nucleocapsid Health Canada/Interim Order 25T/kit n/a (Hangzhou) Co Ltd see IFU see IFU see IFU Visual read Device protein TGA (China) antigen

SARS-CoV-2 Assure Tech Ecotest COVID-19 Antigen nucleocapsid n/a (Hangzhou) Co Ltd see IFU see IFU see IFU TGA Saliva Test Kit protein (China) antigen

SARS-CoV-2 receptor magnetic force- assisted Sampinute COVID-19 Antigen BBB Inc. (distributed binding SAMPINUTE™ Analyzer see IFU see IFU see IFU electrochemical US FDA EUA MIA by Celltrion USA, Inc.) domains sandwich (RBDs) spike immunoassay proteins

SARS-CoV-2 US FDA EUA chromatographic BD Veritor System for Rapid Becton, Dickinson and nucleocapsid Health Canada/Interim Order 256082 30T/kit BD Veritor™ Plus Analyzer see IFU see IFU see IFU digital Detection of SARS-CoV-2 Company protein immunoassay PMDA antigen TGA

SARS-CoV-2 nucleocapsid BD Veritor System for Rapid chromatographic Becton, Dickinson and protein and 256088 Detection of SARS-CoV-2 & 30T/kit BD Veritor™ Plus Analyzer see IFU see IFU see IFU digital US FDA EUA Company Influenza A/B Flu A+B immunoassay nucleo-protein antigen

Beijing Wantai Wantai SARS-CoV-2 Ag Rapid Biologicalpharmacy see IFU see IFU see IFU see IFU TGA Test (Colloidal Gold) Enterprise Co Ltd (China)

NowCheck COVID-19 Antigen RG1901DG BioNote Inc see IFU see IFU see IFU see IFU TGA Test

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 49/65 SARS-CoV-2 Antigen Rapid Diagnostic Tests

SARS-CoV-2 nucleocapsid SW40006 BIOSYNEX COVID-19 Ag BSS see IFU n/a Biosynex Swiss SA see IFU see IFU see IFU Visual read ANSM protein antigen

SARS-CoV-2 SW40010 nucleocapsid BIOSYNEX COVID-19 Ag+ see IFU n/a Biosynex Swiss SA see IFU see IFU see IFU Visual read ANSM SW40010F protein antigen

COVID-19 Antigen Rapid Test SARS-CoV-2 n/a BTNX Inc see IFU see IFU see IFU Visual Read TGA Cassette antigen

SARS Coronavirus Antigen Kit Canon Medical SARS-CoV-2 Rapiim SARS-CoV-2-N PRT- see IFU see IFU see IFU PMDA Systems Corporation antigen C2N01A

Celltrion DiaTrustTM COVID- Celltrion USA, Inc SARS-CoV-2 25T/kit n/a see IFU see IFU see IFU Visual Read US FDA EUA 19 Ag Rapid Test (Humasis, Co Ltd.) antigen

For consumables Quampas COVID-19 Antigen and details of Cellspect Co.,Ltd. see IFU see IFU see IFU PMDA Test Kit componants refer to IFU

OnSite® COVID-19 Ag Point SARS-CoV-2 of care test / Aria® COVID-19 n/a CTK Biotech Inc see IFU see IFU see IFU Visual Read TGA antigen Ag Rapid Test

QuickNavi-COVID19 Ag Denka Co., Ltd. see IFU see IFU see IFU PMDA

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 50/65 SARS-CoV-2 Antigen Rapid Diagnostic Tests

SARS-CoV-2 nucleocapsid 311500 LIAISON® SARS-CoV-2 Ag see IFU see IFU DiaSorin see IFU see IFU see IFU Reader required US FDA EUA protein antigen

SARS-CoV-2 nucleocapsid Ellume COVID-19 Home Test see IFU Ellume Ltd see IFU see IFU see IFU Reader required US FDA EUA protein antigen

Empowered CovClear COVID-19 Antigen Diagnostics LLC TGA Test (United States Of America)

Fuji Dry Chem IMMUNO AG Fujifilm Corporation see IFU see IFU see IFU PMDA Handy COVID-19 Ag

Lumipulse SARS-CoV-2 Ag Fujirebio Inc see IFU see IFU see IFU PMDA

Lumipulse Presto SARS-CoV-2 Fujirebio Inc see IFU see IFU see IFU PMDA Ag

SARS-CoV-2 nucleocapsid 231906 ESPLINE SARS-CoV-2 100T/kit n/a Fujirebio Inc see IFU see IFU see IFU PMDA protein antigen

SARS-CoV-2 GenBody Inc (Korea - nucleocapsid US FDA EUA COVAG025-U GenBody COVID-19 Ag 25T/kit see IFU see IFU see IFU Visual read Republic of) protein TGA antigen

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 51/65 SARS-CoV-2 Antigen Rapid Diagnostic Tests

Guangzhou Decheng 2019-nCoV Ag Saliva Rapid Biotechnology Co Ltd TGA Test Card (China)

GSD NovaGen SARS CoV-2 Hangzhou Alltest TGA Rapid Test Biotech Co Ltd

COVID-19 Antigen Rapid Test Hangzhou Alltest TGA (Oral Fluid) ICOV-802 Biotech Co Ltd

HANGZHOU BIOTEST COVID-19 Antigen Rapid Test BIOTECH NO LTD TGA Cassette (China)

LYHER Novel Coronavirus Hangzhou Laihe (Covid-19) Antigen Test Kit TGA Biotech Co Ltd (China) (Colloidal Gold)

Novel Coronavirus (SARS-CoV- Hangzhou Realy Tech TGA 2) Antigen rapid test Co Ltd (China)

Hangzhou Testsea Testsea SARS-CoV-2 Antigen Biotechnology Co Ltd TGA Test Kit (China)

For consumables Nichirei Biosciences and details of Immunofine SARS-COV-2 see IFU see IFU see IFU PMDA Inc componants refer to IFU

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 52/65 SARS-CoV-2 Antigen Rapid Diagnostic Tests

SARS-CoV-2 InBios International, nucleocapsid COVAG-RC SCoV-2 Ag Detect Rapid Test 50T/kit n/a see IFU see IFU see IFU Visual read US FDA EUA Inc. protein antigen

InnoScreen COVID-19 Innovation Scientific see IFU see IFU see IFU TGA Antigen Rapid Test Device Pty Ltd (Australia)

PixoTest® COVID-19 AG Test iXensor Co Ltd TGA Kit (Taiwan)

SARS-CoV-2 KBM line check nCoV (stick nucleocapsid n/a Kojin Bio Co., Ltd. see IFU see IFU see IFU Visual read PMDA type) protein antigen

SARS-CoV-2 Clip COVID Rapid Antigen nucleocapsid 25T/kit Clip Analyzer Luminostics, Inc see IFU see IFU see IFU Reader required US FDA EUA Test protein antigen

SARS-CoV-2 LumiraDx SARS-CoV-2 Ag nucleocapsid 25T/kit LumiraDx Platform LumiraDx UK Ltd. see IFU see IFU see IFU Reader required US FDA EUA Test protein antigen

For consumables STANDARD Q MALCOM COMPANY and details of see IFU see IFU see IFU PMDA COVID-19 Ag Test LIMITED componants refer to IFU

SARS-CoV-2 Fuji Dry Chem IMMNO AG nucleocapsid n/a Mizuhomedy Co., Ltd. see IFU see IFU see IFU Visual read PMDA Cartridge COVID-19 Ag protein antigen

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 53/65 SARS-CoV-2 Antigen Rapid Diagnostic Tests

SARS-CoV-2 Quick Chaser Auto SARS-CoV- nucleocapsid n/a Mizuhomedy Co., Ltd. see IFU see IFU see IFU Reader required PMDA 2 protein antigen

MP Biomedicals Asia Rapid SARS-CoV-2 Antigen Pacific Pte Ltd TGA Test Card (Singapore)

SARS-CoV-2 nucleocapsid COVID-19 and Influenza A+B Nichirei Biosciences protein n/a see IFU see IFU see IFU Reader required PMDA Antigen Combo Test Inc. antigen / Influenza A + B Antigen

SARS-CoV-2 1001-0614 InteliSwab COVID-19 Rapid 25T/kit OraSure Technologies, nucleocapsid n/a see IFU see IFU see IFU Visual read US FDA EUA 1001-0615 Test Pro 100T/kit Inc. protein antigen

VITROS SARS-CoV-2 VITROS Immunodiagnostic US FDA EUA 3600 Immunodiagnostic System and the Ortho Clinical nucleocapsid 619 9949 Products SARS-CoV-2 Antigen 100T/kit see IFU see IFU see IFU Analyzer required Health Canada/Interim Order VITROS 5600/XT 7600 Diagnostics, Inc protein Reagent Pack PMDA Integrated Systems antigen

SARS-CoV-2 nucleocapsid Health Canada Interim Order COV05 Pcl COVID19 AG Rapid Fia Pcl Immunofluorescence Analyzer Pclok Ez Pcl Inc. see IFU see IFU see IFU Analyzer required protein TGA antigen

SARS-CoV-2 INDICAID COVID-19 Rapid PHASE Scientific nucleocapsid 25T/kit n/a see IFU see IFU see IFU Visual read US FDA EUA Antigen Test International Limited protein antigen

SARS-CoV-2 Premier Medical Sure Status COVID-19 Antigen nucleocapsid SS03P25 25T/kit n/a Corporation Private see IFU see IFU see IFU Visual read WHO EUL Card Test protein Limited antigen

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 54/65 SARS-CoV-2 Antigen Rapid Diagnostic Tests

SARS-CoV-2 Simoa® SARS-COV-2 N Simoa nucleocapsid 25T/kit Quanterix Corporation see IFU see IFU see IFU Reader required US FDA EUA Protein Antigen Test HD-X Analyzer protein antigen

SARS-CoV-2 nucleocapsid 20387 QuickVue SARS Antigen Test 25T/kit n/a Quidel Corporation see IFU see IFU see IFU Visual read US FDA EUA protein antigen

SARS-CoV-2 nucleocapsid 20396 QuickVue SARS Antigen Test 25T/kit n/a Quidel Corporation see IFU see IFU see IFU Visual read Health Canada Interim Order protein antigen

SARS-CoV-2 Sofia and nucleocapsid US FDA EUA 20374 Sofia SARS Antigen FIA 25T/kit Quidel Corporation see IFU see IFU see IFU Reader required Sofia 2 instrument protein TGA antigen

SARS-CoV-2 nucleocapsid US FDA EUA Sofia 2 Flu + SARS Antigen Sofia and 20380 25T/kit Quidel Corporation protein see IFU see IFU see IFU Reader required PMDA FIA Sofia 2 instrument antigen and Health Canada Interim Order Influenza A

SARS-CoV-2 Omnia SARS-CoV-2 Antigen Qorvo Biotechnologies Omnia System Qorvo Biotechnologies, nucleocapsid QPR8302 20T/kit see IFU see IFU see IFU Reader required US FDA EUA Test (Catalog number # QPR9002) LLC protein antigen

SARS-CoV-2 nucleocapsid BIOCREDIT COVID-19 Ag n/a RapiGEN Inc see IFU see IFU see IFU Visual Read TGA protein antigen

SARS-CoV-2 Eclusis Reagent SARS-CoV-2 Roche Diagnostics Co., nucleocapsid n/a see IFU see IFU see IFU see IFU PMDA Ag Ltd protein antigen

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 55/65 SARS-CoV-2 Antigen Rapid Diagnostic Tests

SARS-CoV-2 SARS-Cov-2 Rapid Antigen Roche Diagnostics Co., nucleocapsid n/a see IFU see IFU see IFU Visual Read PMDA Test Ltd protein antigen

SARS-CoV-2 STANDARD Q COVID-19 Ag nucleocapsid TGA 09COV30D n/a SD Biosensor Inc. see IFU see IFU see IFU Visual Read Test protein WHO EUL antigen

SARS-CoV-2 SD Biosensor Inc. SARS-Cov-2 Rapid Antigen nucleocapsid 9901-NCOV-01G n/a (distributed by Roche see IFU see IFU see IFU Visual Read TGA Test protein Diagnostics Australia) antigen

SARS-CoV-2 SD Biosensor Inc. SARS-Cov-2 Rapid Antigen nucleocapsid 9901-NCOV-04G n/a (distributed by Roche see IFU see IFU see IFU Visual Read Health Canada Interim Order Test protein Diagnostics Australia) antigen

For consumables SEKISUI MEDICAL and details of RapidTesta SARS-CoV-2 see IFU see IFU see IFU PMDA CO., LTD. componants refer to IFU

HISCL SARS-CoV-2 Ag Assay Sysmex Corporation see IFU see IFU see IFU PMDA Kit

For consumables AFIAS COVID-19 Ag Test TOKYO BOEKI and details of see IFU see IFU see IFU PMDA Cartridge MEDISYS INC componants refer to IFU

For consumables TOSOH and details of CL AIA-PACK SARS-CoV-2-Ag see IFU see IFU see IFU PMDA CORPORATION componants refer to IFU

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 56/65 SARS-CoV-2 Antigen Rapid Diagnostic Tests

For consumables Immuno Ace SARS-CoV-2 / and details of Towns Co., Ltd. see IFU see IFU see IFU PMDA Capilia SARS-CoV-2 componants refer to IFU

For consumables and details of ImmunoArrow SARS-CoV-2 TOYOBO CO., LTD. see IFU see IFU see IFU PMDA componants refer to IFU

SARS-CoV-2 Rapid SARS-CoV-2 Antigen Xiamen Boson Biotech nucleocapsid n/a see IFU see IFU see IFU Visual read Health Canada Interim Order Test Card Co., Ltd. (China) protein antigen

N/A- NOT APPLICABLE

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 57/65 Version 33 2021-09-24

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)

Important Precautionary statements:

Based on current data, WHO does not recommend the use of antibody-detecting rapid diagnostic tests for patient care but encourages the continuation of work to establish their usefulness in disease surveillance and epidemiologic research. (https://www.who.int/news-room/commentaries/detail/advice-on-the-use-of-point-of-care-immunodiagnostic-tests-for-covid-19)

SARS-CoV-2 Antibody Rapid Diagnostic Tests

ACON SARS-CoV-2 IgG/IgM ACON Laboratories, L031-11711 see IFU n/a n/a IgG/IgM see IFU see IFU see IFU US FDA EUA Rapid Test Inc

RapCov™ Rapid COVID-19 A-RAPCOV01 see IFU n/a n/a Advaite IgG see IFU see IFU see IFU US FDA EUA Test

Assure COVID-19 IgG/IgM Assure Tech. Health Canada/Interim Order COV-W23M see IFU n/a n/a IgG/IgM see IFU see IFU see IFU Rapid Test Device (Hangzhou Co., Ltd) US FDA EUA

Assure COVID-19 IgG/IgM Rapid Test Device rebranded Assure Tech. see IFU n/a n/a IgG/IgM see IFU see IFU see IFU US FDA EUA as Ecotest COVID-19 IgG/IgM (Hangzhou Co., Ltd) Rapid Test Device

Assure COVID-19 IgG/IgM Rapid Test Device rebranded Assure Tech. see IFU n/a n/a IgG/IgM see IFU see IFU see IFU US FDA EUA as Fastep COVID-19 IgG/IgM (Hangzhou Co., Ltd) Rapid Test Device

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 58/65 SARS-CoV-2 Antibody Rapid Diagnostic Tests

NOVA Test® COVID-19 Atlaslink Beijing IgG/IgM Antibody Test see IFU n/a n/a Technology Co Ltd IgG/IgM see IFU see IFU see IFU TGA (Colloidal Gold) (China)

AtomoRapid™ COVID-19 Atomo Diagnostics see IFU n/a n/a IgG/IgM see IFU see IFU see IFU TGA IgM/IgG Antibody Test Limited

Beijing Wantai WJ-2710, Wantai SARS-CoV-2 Ab Rapid 10 Biological Pharmacy US FDA EUA n/a n/a IgG/IgM see IFU see IFU see IFU WJ-2750 Test kit 50 Enterprise Co Ltd TGA (China)

Tell Me Fast Novel Coronavirus (COVID-19) B251C n/a n/a Biocan Diagnostics Inc. IgG/IgM see IFU see IFU see IFU US FDA EUA IgG/IgM Antibody Test

SARS-CoV-2 IgM/IgG Biohit Healthcare US FDA EUA RTA0203 25 n/a n/a IgG/IgM see IFU 2 to 30°C see IFU Antibody Test Kit (Hefei) Co., Ltd. TGA

Rapid Response COVID-19 COV-13C25 see IFU n/a n/a Btnx Inc. (Canada) IgG/IgM see IFU see IFU see IFU Health Canada/Interim Order IgG/IgM Rapid Test Device

COVID-19 IgG/IgM Rapid Test see IFU n/a n/a Btnx Inc. (Canada) IgG/IgM see IFU see IFU see IFU TGA

serum, 5515C025 25 plasma Cellex Inc (EDTA or qSARS-CoV-2 IgG/IgM Rapid US FDA EUA 5515C050 50 n/a n/a (United States of IgG/IgM 12 2 to 30°C citrate), or Test TGA America) venipuncture 5515C100 100 whole blood

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 59/65 SARS-CoV-2 Antibody Rapid Diagnostic Tests

OnSite COVID-19 IgG/IgM TGA R0180C Rapid Test (Aria COVID-19 see IFU n/a n/a CTK Biotech Inc (USA) IgG/IgM see IFU see IFU see IFU removed from US FDA EUA IgG/IgM Rapid Test)

2039 CovAb SARS-CoV-2 Ab Test see IFU n/a n/a Diabetomics, Inc. IgG/IgA/IgM see IFU see IFU see IFU US FDA EUA

SARS-CoV-2 Antibody Test Guangzhou Wondfo W195 see IFU n/a n/a IgG/IgM see IFU see IFU see IFU TGA (Lateral Flow Method) Biotech Co Ltd (China)

2019-n-CoV IgG/IgM Rapid Hangzhou Alltest TGA INCP-402 see IFU n/a n/a IgG/IgM see IFU see IFU see IFU Test Cassette Biotech Co Ltd (China) removed from US FDA EUA

COVID-19 IgG/IgM Rapid Test Hangzhou Biotest TGA see IFU n/a n/a IgG/IgM see IFU see IFU see IFU Cassette Biotech Co Ltd (China) removed from US FDA EUA

RightSign™ COVID-19 Hangzhou Biotest see IFU n/a n/a IgG/IgM see IFU see IFU see IFU US FDA EUA IgG/IgM Rapid Test Cassette Biotech Co Ltd (China)

RightSign™ COVID-19 Hangzhou Biotest IgG/IgM Rapid Test Cassette Biotech Co Ltd (China) rebranded to see IFU n/a n/a IgG/IgM see IFU see IFU see IFU US FDA EUA distributed by CoronaCHEK COVID-19 CLIAwaived Inc. IgG/IgM Rapid Test Cassette

RightSign™ COVID-19 Hangzhou Biotest IgG/IgM Rapid Test Cassette Biotech Co Ltd (China) rebranded to see IFU n/a n/a IgG/IgM see IFU see IFU see IFU US FDA EUA distributed by Premier Premier Biotech COVID-19 Biotech Inc. IgG/IgM Rapid Test Cassette

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 60/65 SARS-CoV-2 Antibody Rapid Diagnostic Tests

COVID-19 IgG/IgM Rapid Test Hangzhou Clongene see IFU n/a n/a IgG/IgM see IFU see IFU see IFU TGA Cassette Biotech Co Ltd (China)

LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Hangzhou Laihe 303002 Antibody see IFU n/a n/a IgG/IgM see IFU see IFU see IFU IFU update US FDA EUA Biotech Co Ltd (China) Combo Test Kit (Colloidal Gold)

LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Hangzhou Laihe Combo Test Kit (Colloidal Biotech Co Ltd (China) see IFU n/a n/a IgG/IgM see IFU see IFU see IFU IFU update US FDA EUA Gold) rebranded to QUICKKIT distributed by Novel Coronavirus (2019- Unisources Group LLC. nCov) IgM/IgG Antibody Combo Test Kit

2019-nCOV/COVID-19 Hangzhou Realy Tech TGA see IFU n/a n/a IgG/IgM see IFU see IFU see IFU IgG/IgM Rapid Test Device Co Ltd (China) removed from US FDA EUA

Healgen Scientific COVID-19 IgG/IgM Rapid Test Limited Liability US FDA EUA GCCOV-402a 25 n/a n/a IgG/IgM see IFU see IFU see IFU Cassette Company (United TGA States Of America)

InnoScreenTM COVID-19 Innovation Scientific see IFU n/a n/a IgG/IgM see IFU see IFU see IFU TGA IgG/IgM Rapid Test Pty Ltd (Australia)

Innovita (Tangshan) 2019-nCov Ab Test (Colloidal US FDA EUA YF319C see IFU n/a n/a Biological Technology IgG/IgM see IFU see IFU see IFU Gold) TGA Co Ltd (China)

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 61/65 SARS-CoV-2 Antibody Rapid Diagnostic Tests

Lumivi Diagnostics SARS-CoV- International Point Of B25-CSER1001 see IFU n/a n/a IgG/IgM see IFU see IFU see IFU Health Canada/Interim Order 2 IgG Rapid Test Kit Care, Inc. (Canada)

Jiangsu Well Biotech Orawell IgM/IgG Rapid Test see IFU n/a n/a IgG/IgM see IFU see IFU see IFU US FDA EUA Co., Ltd.

INDICAID COVID-19 IgM/IgG Jiangsu Well Biotech Rapid Test rebranded by Phase Co., Ltd. distributed by see IFU n/a n/a IgG/IgM see IFU see IFU see IFU US FDA EUA Scientific International Phase Scientific Limited International Limited

Rapid COVID-19 IgM/IgG see IFU n/a n/a Megna Health, Inc. IgG/IgM see IFU see IFU see IFU US FDA EUA Combo Test Kit

243001N-10 10 243001N-20 Nadal COVID-19 IgG/IgM Test 20 Nal Von Minden Gmbh n/a n/a IgG/IgM see IFU see IFU see IFU Health Canada/Interim Order 243001N-50 (pack Of 10) 50 (Germany) 243001N-100 100

Nantong Egens COVID-19 IgG/IgM Rapid Test TGA see IFU n/a n/a Biotechnology Co Ltd IgG/IgM see IFU see IFU see IFU Kit removed from US FDA EUA (China)

Newscen Coast Bio- COVID-19 IgG/IgM Rapid Test TGA see IFU n/a n/a Pharmaceutical Co Ltd IgG/IgM see IFU see IFU see IFU Cassette removed from US FDA EUA (China)

ADEXUSDx COVID-19 Test 50 n/a n/a NOWDiagnostics, Inc Total Ig see IFU see IFU see IFU US FDA EUA

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 62/65 SARS-CoV-2 Antibody Rapid Diagnostic Tests

MidaSpotTM COVID-19 NBPC-0007 25 n/a n/a Nirmidas Biotech, Inc IgG/IgM see IFU see IFU see IFU US FDA EUA Antibody Combo Detection Kit

Nirmidas COVID-19 (SARS- CoV-2) IgM/IgG Antibody NBPC-0001-xx see IFU n/a n/a Nirmidas Biotech, Inc IgG/IgM see IFU see IFU see IFU US FDA EUA Detection Kit

NTBIO One Step Rapid Test - NTBIO Diagnostics Inc COVID-19 IgG/IgM Antibody see IFU n/a n/a IgG/IgM see IFU see IFU see IFU TGA (Canada) Test

SARS-CoV-2 IgM/lgG Qingdao Hightop see IFU n/a n/a IgG/IgM see IFU see IFU see IFU TGA Antibody Rapid Test Biotech Co Ltd (China)

CD- Sienna-Clarity COVIBLOCK COV19CW/102223/ COVID-19 IgG/IgM Rapid Test see IFU n/a n/a Salofa Oy IgG/IgM see IFU see IFU see IFU US FDA EUA 102224 Cassette

COGT025E, 25T/kit SGTi-flex COVID-19 IgG n/a n/a Sugentech, Inc IgG see IFU see IFU see IFU US FDA EUA COGT005E 5T/kit

TBG SARS-CoV-2 IgG / IgM TBG Biotechnology 20010 Rapid see IFU n/a n/a IgG/IgM see IFU see IFU see IFU US FDA EUA Corp. Test Kit

VID35-08-011 VivaCheck Biotech VID35-08-012 VivaDiag™ COVID-19 40T/kit n/a n/a (Hangzhou) Co Ltd IgG/IgM see IFU see IFU see IFU TGA VID35-08-013 IgM/IgG Rapid Test (China) VID35-08-014

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 63/65 SARS-CoV-2 Antibody Rapid Diagnostic Tests

Wuhan EasyDiagnosis SARS-CoV-2 IgM/IgG see IFU n/a n/a Biomedicine Co Ltd IgG/IgM see IFU see IFU see IFU TGA Antibody Test Kit (China)

Xiamen Biotime Biotechnology Co., Ltd. (China) distributed by O’Neill Medical LLC, HORIBA instrument BIOTIME SARS-CoV-2 incorporated, IgG/IgM Rapid Qualitative 25T/kit n/a n/a IgG/IgM see IFU see IFU see IFU US FDA EUA Lifesaving Global LLC, Test THE RUHOF CORPORATION, Marlan’s Group Us Inc, and JEMF Pharma

Xiamen Biotime Biotechnology Co., Ltd. rebranded by Telepoint (China) Medical 25T/kit n/a n/a IgG/IgM see IFU see IFU see IFU US FDA EUA distributed by Services, LLC Telepoint Medical Services, LLC

BIOTIME SARS-CoV-2 Xiamen Biotime

IgG/IgM Rapid Qualitative see IFU n/a n/a Biotechnology Co Ltd IgG/IgM see IFU see IFU see IFU TGA Test (China)

COVID-19 IgG/IgM Rapid Zhejiang Orient Gene see IFU n/a n/a IgG/IgM see IFU see IFU see IFU TGA GCCOV-402a Test Cassette Biotech Co Ltd (China)

Zhongshan Chuangyi COVID-19 IgG/IgM Rapid Test Biochemical see IFU n/a n/a IgG/IgM see IFU see IFU see IFU TGA Kit Engineering Co Ltd (China)

N/A- NOT APPLICABLE

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 64/65 Version 33 2021-09-24

List of SARS-CoV-2 products deleted/delisted Products not eligible for procurement

Manufacturer Product Number of tests Deleted Product Name Manufacturer Reason for deletion/delisting Catalogue per kit period number

Autobio Diagnostics Co., Ltd RTA0203 Anti-SARS-CoV-2 Rapid Test 20 Aug-20 US FDA EUA revoked (China)

DPP® COVID-19 IgM/IgG System on DPP Micro Chembio 65-9569-0 20 Jul-20 US FDA EUA revoked Reader or DPP Micro Reader 2 (USA)

GenBody COVID-19 IgM/IgG GenBody Inc (Korea - Republic of) Oct-20 TGA delisted

Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Hangzhou Laihe Biotech Co Ltd (China) Feb-20 TGA delisted Combo Test Kit (Colloidal Gold)

US FDA EUA revoked PCL COVID19 IgG/IgM Rapid Gold PCL Inc (Korea - Republic of) Feb-20 TGA delisted

SGTi-flex COVID-19 IgM/IgG Sugentech Inc Oct-20 US FDA EUA revoked

Diagnostic Kit for IgM/IgG Antibody to Coronavirus US FDA EUA revoked Zhuhai Livzon Diagnostics Inc (China) Jan-21 (SARS-CoV-2) (Lateral Flow) TGA delisted

N/A- NOT APPLICABLE

LIST OF DIAGNOSTIC PRODUCTS-DELISTED PRODUCTS 65/65