Version 2 8 May 2020 List of SARS-CoV-2 Diagnostic test kits and equipments eligible for procurement according to Board Decision on Additional Support for Country Responses to COVID-19 (GF/B42/EDP11) SARS-CoV-2 Nuclear Acid Amplification Technologies Product codes superscripted with a * (star) mark is WHO prequalified Anticipated Manufacturer Product Product Name Platform Recommended Eligibility Reference detail Manufacturer Detection type Shelf life Specimen type Comments Catalogue number (IVD product) (Extraction and amplification equipement) storage temperature WHO EUL or others (months) 1DROP INC. (imported For consumables E gene and nasopharyng and details of 444213 1COPY COVID-19 QPCR KIT 24T/kit by Luminarie Canada 6 months 15 to 30°C Health Canada/Interim Order RdRp gene eal swabs componants refer Inc.) to IFU For consumables US FDA EUA Abbott Diagnostics nasopharyng and details of 190-000 ID NOW COVID-19 Test Kit 96T/kit ID NOW Instrument RdRp segment see IFU 2 to 30 ºC Health Canada/Interim Order Scarborough Inc eal swabs componants refer to IFU WHO EUL For consumables US FDA EUA Abbott RealTime SARS-CoV-2 RdRp and N and details of Health Canada/Interim Order 09N77-090 96T/kit Abbott m2000 Abbott Molecular see IFU -25 to -15 ºC see IFU RT-PCR Kit genes componants refer TGA to IFU WHO EUL CFX96™ Touch Real- Time PCR Detection AltoStar® System (Bio-Rad) For consumables RealStar® SARS-CoV-2 RT- Altona Diagnostics and details of 821025 384T/kit Automation see IFU -25 to -15 ºC see IFU US FDA EUA PCR Kit U.S. GmbH componants refer System AM16 CFX96™ Touch Deep to IFU Well Real-Time PCR Detection System (BioRad nasal, N gene and nasopharyng For consumables iAMP® COVID-19 Detection CFX96 Real-Time and details of iAMP-COVID19-100 100T/kit not required Atila BioSystems, Inc. the ORF-1ab 12 months lower than -20 ºC eal and US FDA EUA Kit System componants refer gene oropharynge to IFU al swab AusDiagnostics respiratory For consumables AusDiagnostics Pty Ltd and details of virus panel (including SARS- see IFU see IFU see IFU TGA (Australia) componants refer CoV-2) test to IFU nasal, N gene (N1 nasopharyng For consumables Becton, Dickinson and ambient and details of US FDA EUA 445003 BD SARS-CoV-2 Reagents 24T/kit BD MAX™ System and N2 see IFU eal and Company temperature componants refer Health Canada/Interim Order regions) oropharynge to IFU al swab List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 1/10 SARS-CoV-2 Nuclear Acid Amplification Technologies Product codes superscripted with a * (star) mark is WHO prequalified Anticipated Manufacturer Product Product Name Platform Recommended Eligibility Reference detail Manufacturer Detection type Shelf life Specimen type Comments Catalogue number (IVD product) (Extraction and amplification equipement) storage temperature WHO EUL or others (months) For consumables Becton, Dickinson and nasopharyng and details of 444213 BioGX SARS-CoV-2 Reagents 24T/kit BD MAX™ System 6 months 15 to 30°C US FDA EUA Company eal swabs componants refer to IFU Real-Time Fluorescent RT- QIAamp Virus Applied Biosystems For consumables throat swabs and details of PCR Kit for Detecting SARS- 50T/kit RNA Mini Kit (cat. 7500 Real-Time PCR BGI Genomics Co. Ltd ORF1ab 12 months lower than -18 ºC US FDA EUA or BALF componants refer 2019-nCoV #52904 or 52906). System to IFU 423745 6T/kit For consumables FilmArray® 2.0 and/or the FilmArray® ORF1ab and nasopharyng and details of BioFire® COVID-19 Test BioFire Defense, LLC see IFU 15 to 30°C US FDA EUA Torch Instrument Systems ORF8 eal swabs componants refer 423744 30T/kit to IFU 7500 & 7500 Fast Real- Time PCR System (Applied Biosystems) EMAG® (bioMérieux) QuantStudio12 Flex (QS12) instrument (Applied Biosystems) 30 and For consumables ARGENE® SARS-COV-2 R- 120T/kit N gene and and details of 423735 NucliSENS LightCycler 480 BioMérieux SA see IFU -31 to -15 ºC see IFU US FDA EUA GENE® (depending RdRp gene componants refer easyMAG (System II) on PCR) to IFU (bioMérieux) (Roche) CFX96 Touch Real- QIASymphony SP Time PCR (QIAgen) Detection System (Bio- Rad) MagNA Pure 96 Rotor‑Gene Q (Roche) (Qiagen) ThermoFisher MagMAX™ Viral/Pathogen QX200™ PCR Nucleic Acid Systems Isolation Kit (Cat For consumables 2019-nCoV CDC ddPCR and details of 12008202 200T/kit No. A48310, 1000 BioRad P and N genes see IFU -25 to -15 ºC see IFU US FDA EUA Triplex Probe Assay reactions) componants refer to IFU QIAamp Virus QXDx™ Droplet RNA Mini Kit (cat. Digital™ PCR Systems # 52906) List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 2/10 SARS-CoV-2 Nuclear Acid Amplification Technologies Product codes superscripted with a * (star) mark is WHO prequalified Anticipated Manufacturer Product Product Name Platform Recommended Eligibility Reference detail Manufacturer Detection type Shelf life Specimen type Comments Catalogue number (IVD product) (Extraction and amplification equipement) storage temperature WHO EUL or others (months) GeneXpert Dx For consumables US FDA EUA Genes N2 and and details of XPRSARS-COV2-10 Xpert® Xpress SARS-CoV-2 10T/kit GeneXpert Infinity Systems Cepheid see IFU 2 to 28°C see IFU Health Canada/Interim Order E componants refer to IFU TGA GeneXpert Xpress System (Tablet and Hub Configurations) For consumables VIASURE SARS-CoV-2 Real CerTest Biotec SL / nasopharyng and details of see IFU see IFU TGA Time PCR Detection Kit Abacus dx eal swabs componants refer to IFU For consumables VIASURE SARS-CoV-2 S gene CerTest Biotec SL / nasopharyng and details of see IFU see IFU TGA Real Time PCR Detection Kit Becton Dickinson eal swabs componants refer to IFU QIAamp Virus For consumables LOGIX SMART™ Coronavirus CoDx Box (BMS, Bio nasopharyng and details of COVID-K-001 100T/kit RNA Mini Kit Co-Diagnostics, Inc 12 months lower than -20 ºC US FDA EUA Disease 2019 (COVID-19) Kit Molecular Systems) eal swabs componants refer (Qiagen) to IFU Applied Biosystems™ DC-11-0007 24T/kit QuantStudio 5 Real- nasal swabs, Time PCR Instrument nasopharyng Thermo Fisher For consumables QuantiVirus SARS-CoV-2 Test N, Orf1ab and eal swabs, and details of PureLink™ viral DiaCarta, Inc 12 months -25 to -15 ºC US FDA EUA kit E genes oropharynge componants refer RNA/DNA mini kit DC-11-0008 48T/kit Applied Biosystems™ al swabs, and to IFU 7500 Fast Dx Real- sputum Time PCR Instrument DC-11-0009 480T/kit For consumables ORF1ab and S and details of US FDA EUA MOL4150 Simplexa™ COVID-19 Direct 24T/kit LIAISON® MDX DiaSorin Molecular see IFU -30 to -10 ºC see IFU gene componants refer Health Canada/Interim Order to IFU 7500 Fast Dx Fast Track Diagnostics NucliSENS® Real-Time PCR For consumables 11416302 (FTD-114- Luxembourg S.á.r.l. (a ORF1ab and N and details of FTD SARS-CoV-2 96T/kit easyMAG® System Instrument see IFU -30 to -10 ºC see IFU US FDA EUA 96) Siemens Healthineers gene componants refer (bioMéreux) (Applied Company) to IFU Biosystems™) List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 3/10 SARS-CoV-2 Nuclear Acid Amplification Technologies Product codes superscripted with a * (star) mark is WHO prequalified Anticipated Manufacturer Product Product Name Platform Recommended Eligibility Reference detail Manufacturer Detection type Shelf life Specimen type Comments Catalogue number (IVD product) (Extraction and amplification equipement) storage temperature WHO EUL or others (months) PCSYHF02-a 48T/kit 7500 Fast Dx QIAamp DSP Viral Real-Time PCR For consumables Fosun COVID-19 RT-PCR Fosun Pharma USA ORF1ab, and details of RNA Mini Kit Instrument 12 months -25 to -15 ºC see IFU US FDA EUA Detection Kit Inc. N and E genes componants refer (Qiagen) (Applied to IFU PCSYHF03-a 96T/kit Biosystems™) For consumables EasyScreen™ SARS-CoV-2 Genetic Signatures Ltd N-gene and E- and details of see IFU see IFU see IFU TGA Detection Kit (Australia) gene componants refer to IFU For consumables ePlex® GenMark Diagnostics, and details of EA008212 12T/kit GenMark ePlex instrument and Software see IFU 2 to 8°C see IFU US FDA EUA SARS-CoV-2 Test Inc componants refer to IFU 96T/kit 7500 Fast Dx Real-Time PCR For consumables QIAamp DSP Viral ORF1ab, and details of GS COVID-19 RT-PCR KIT Instrument GenoSensor LLC see IFU -20°C see IFU US FDA EUA RNA Mini Kit N and E genes componants refer (Applied to IFU 384T/kit Biosystems™) nasal, QuantStudio™ 3D QIAamp® DSP nasopharyng For consumables COVID-19 RT-Digital PCR Digital and details of CV0202 48T/kit Viral RNA Gnomegen LLC see IFU -10 to -30 ºC eal, and US FDA EUA Detection Kit PCR System (Applied componants refer Mini Kit (Qiagen) oropharynge Biosystems) to IFU al swab ORF1ab For consumables US FDA EUA Panther Fusion SARS-CoV-2 Region 1 and details of PRD-03455 96T/kit Panther System Hologic Inc 2 months 2 to 8°C see IFU Health Canada/Interim Order Kit ORF1ab componants refer TGA Region 2 to IFU KingFisher Flex nucleic acid Applied Biosystems For consumables Ipsum Diagnostics, and details of COV-19 IDx assay 96T/kit extraction QuantStudio12 Flex see IFU see IFU see IFU US FDA EUA LLC componants refer systems QS12 (QS12) instrument to IFU instrument 7500 Fast Dx Real- Time PCR nasopharyng instrument (Applied eal swab, QIAamp® DSP anterior For consumables Smart Detect™ SARS-CoV-2 Biosystems) InBios International, and details of COV2-E 48T/kit Viral RNA see IFU -10 to -30 ºC nasal swab US FDA EUA rRT-PCR Kit Inc componants refer Mini Kit (Qiagen) CFX96 Touch Real- and to IFU Time PCR midturbinate Detection