Covid19 Diagnosticproducts List en

Version 29
2021-03-19
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 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
SARS-CoV-2 Nuclear Acid Amplification Technologies
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) (months)
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

Quantstudio5 (Thermo by Luminarie Canada E gene and and details of US FDA EUA
444213 1COPY COVID-19 QPCR KIT 100T/kit see IFU see IFU see IFU componants refer
Fisher Scientific) RdRp gene 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
1/54

Applied Biosystems
Quantstudio3
(Thermo Fisher
TRUPCR® Viral Scientific) For consumables
3B Blackbio Biotech
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) to IFU
(3B213V/3B214V) Rotor-Gene Q 5plex
HRM
(Qiagen)
For consumables
3D Biomedicine
3DMed 2019-nCoV RT-qPCR and details of
3103010011 96T/kit see IFU Science & Technology see IFU see IFU see IFU see IFU WHO EUL
Detection Kit componants refer
Co., Ltd. to IFU
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
09N79-096 Alinity m Resp-4-Plex 96T/kit Alinity m System Abbott Molecular see IFU see IFU see IFU US FDA EUA
Influenza A & componants refer
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
For consumables
Accelerate
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

2/54

NucliSENS®
easyMAG®
(bioMérieux) For consumables
13279F N gene, ORF-1
MassARRAY® SARS-CoV-2 and details of
13278D 960T/kit MassARRAY System Agena Bioscience, Inc. and ORF-1ab see IFU see IFU see IFU US FDA EUA
Panel componants refer
13281D gene to IFU
KingFisher Flex
Purification System
(ThermoFisher)
CFX96™ Touch Real-

Time PCR Detection
System (Bio-Rad) For consumables
AltoStar®
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
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 and details of
TRIzol™ RNA
QuantStudio 5 Real- componants refer
Extraction Kit
Time PCR to IFU
(Invitrogen)
System
DX-1001-002-000 500T/kit
Linea™ COVID-19 Real-Time Note: See WHO
Mag-Bind Viral Applied DNA Sciences S genes 6 months see IFU see IFU Information Notice
US FDA EUA
PCR Assay Kit assay kit
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

3/54

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
Zymo Quick-RNA CFX96™ Touch Real-

Viral Kit RNA Time PCR Detection
Extraction Kit System (Bio-Rad) For consumables
Assurance Scientific and details of
Assurance SARS-CoV-2 Panel see IFU N gene see IFU see IFU see IFU componants refer
US FDA EUA
Laboratories
CFX384™ Touch Deep to IFU
Well Real-Time PCR
Detection System (Bio-
Rad)
CFX96 Real-Time
System (Bio-Rad)
Roche
LightCycler 480
Instrument II Real-
Time PCR System For consumables
N gene and
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
For consumables
AusDiagnostics respiratory
AusDiagnostics Pty Ltd and details of
virus panel (including SARS- see IFU see IFU see IFU componants refer
TGA
(Australia)
CoV-2) test to IFU
For consumables
N gene (N1
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
N gene (N1
For consumables
and N2
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

4/54

For consumables
N gene (N1
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
Real-Time Fluorescent RT- #52904). For consumables
Systems
and details of
MFG030010 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
For consumables
Real-Time Fluorescent RT- QIAamp Virus Applied Biosystems
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) For consumables
Beijing Applied ORF1ab and N
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)

5/54

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
KingFisher Flex 96
Rad)
(ThermoFisher)
Beijing Wantai
Nucleic Acid Beijing Wantai
Wantai SARS-CoV-2 RT-PCR ORF1ab and N
WS-1248 48T/kit Extraction Kit on Biological Pharmacy see IFU see IFU see IFU See IFU WHO EUL
Kit 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

6/54

Applied Biosystems
7500 Real-Time PCR
System
CFX96 Touch Real-

Time PCR
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
Detection System (Bio- ORF1ab gene see IFU see IFU see IFU US FDA EUA
BS-SY-SC2-1000 SARS-CoV-2 1000T/kit 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
SARS-CoV-2 Time PCR Technologies Ltd and details of
100T/kit Detection System (Bio- ORF1ab gene see IFU see IFU see IFU US FDA EUA
rebranded to (distributed by componants refer
BioeXsen SARS-CoV-2 RT PCR Rad) BioeXsen GmbH) to IFU
Rotor‑Gene Q
(Qiagen)

7/54

For consumables
BS-SY-WCOR-304- Bio-Speedy® Direct RT-qPCR Bioeksen R&D and details of
100T/kit See IFU ORF1ab gene see IFU see IFU see IFU componants refer
WHO EUL
100 SARS-CoV-2 Technologies Ltd
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 see IFU US FDA EUA
Torch Instrument Systems ORF8 eal swabs componants refer
423744 30T/kit to IFU
For consumables
(US FDA EUA revoked)
Biofire Respiratory Panel 2.1 FilmArray® 2.0 and/or the FilmArray® BioFire Diagnostics and details of
423738 see IFU see IFU see IFU see IFU Health Canada/Interim Order
(RP2.1) Torch Instrument Systems LLC componants refer
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
Biomeme M1
Sample Prep
Bio-Rad CFX96 For consumables
Biomeme SARS-CoV-2 Real- Cartridge ORF1ab and S US FDA EUA
and details of
96T/kit Kit for RNA 2.0 Biomeme Inc. see IFU see IFU see IFU
Time RT-PCR gene componants refer
to IFU
QuantStudio 5
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

8/54

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

9/54

QIAamp Virus
CFX Opus Real-Time
RNA Mini Kit (cat.
PCR (Biorad)
# 52906)
CFX96 Touch (Biorad)
P and N genes For consumables

Bio-Rad Reliance SARS-CoV-
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 to IFU
CFX96 Dx (Biorad) Influenza B
Applied Biosystems
7500 Fast Dx
Real‑Time PCR
System
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 to IFU
or manual
CFX96 DX Real-Time
PCR
Rad)
CFX96 Real-Time PCR

Rad)

10/54

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
Genes N2 and
For consumables
E and
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
GeneXpert Dx Genes N2 and
For consumables
E and
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 / nasopharyng and details of
see IFU see IFU TGA
Time PCR Detection Kit Abacus dx 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
HBRT-COVID-19 COVID-19 Real-Time PCR Kit 24T/kit Pro Nucleic Acid see IFU see IFU see IFU componants refer
WHO EUL
Detection System (Bio- Biochemistry Ltd. genes
Purification System to IFU
Rad)
96S Real-Time PCR

System (SLAN)

11/54

Clear Dx™ system

comprising
For consumables
Hamilton STAR robotic platform
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
For consumables
QIAamp Virus
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
For consumables
CTK Biotech Inc
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
Cue COVID-19 Test Cue Health Monitoring System Cue Health Inc N Gene see IFU see IFU see IFU US FDA EUA
componants refer
to IFU
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 componants refer
US FDA EUA
regions) to IFU
QuantStudio 12k Flex
(96-well Fast Block)
instrument (Applied
Roche MagNA Biosystems)
Pure-24
Bio Molecular Systems
Mic qPCR (IDEXX
Laboratories)

12/54

YHXB No.
Applied Biosystems™
20170583,
7500 Dx Real-Time
Detection Kit for 2019 Novel YHXB No.
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
RNA, (PCR- Fluorescence genes componants refer TGA
DA0932 96T/kit University
Probing) to IFU
QIAamp Viral
Roche LightCycler480
RNA Mini Kit,
Ⅱ
52906
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
DC-11-0007 24T/kit QuantStudio 5 Real- nasal swabs,
Time PCR Instrument nasopharyng For consumables
Thermo Fisher
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
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 High Throughput 7500 Fast Dx Real- al swabs, and to IFU
Time PCR Instrument sputum
Automated Sample
Preparation
System Bio-Rad CXF 384 Real-
DC-11-0019 480T/kit
Time PCR Instrument

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

13/54

For consumables
Loopamp New Coronavirus
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
For consumables
N gene (N1
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) to IFU
QuantStudio® 5 Real-
Time PCR System
Manual
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- EUROIMMUN For consumables
Time PCR Medizinische ORF1ab and N and details of
MP 2606-0425 EURORealTime SARS-CoV-2 100T/kit see IFU see IFU see IFU componants refer
US FDA EUA
Detection System (Bio- Labordiagnostika AG gene
to IFU TGA
Rad) (Germany)
MP 2606-0100 100T/kit
MP 2606-0200 200T/kit
7500 Fast Dx
Fast Track Diagnostics For consumables
NucliSENS® Real-Time PCR
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 see IFU see IFU US FDA EUA
96) Siemens Healthineers gene componants refer
(bioMéreux) (Applied to IFU
Company)
Biosystems™)

14/54

7500 Fast Dx
Fast Track Diagnostics For consumables
NucliSENS® Real-Time PCR
11416300 (FTD-114- Luxembourg S.á.r.l. (a ORF1ab and N and details of
FTD SARS-CoV-2 32T/kit easyMAG® System Instrument see IFU see IFU see IFU WHO EUL
32) Siemens Healthineers gene componants refer
(bioMéreux) (Applied to IFU
Company)
Biosystems™)
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
QIAamp
QuantStudio™ DX
DSP Viral RNA
Mini Kit (Qiagen)
CFX96 Touch Real-

QIAamp
Time PCR
Viral RNA Mini Kit
(Qiagen) For consumables
Rad)
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
For consumables
QIAamp Real-Time PCR
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™)
For consumables
QIAamp QIAGEN Rotor-
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 componants refer
TGA
PCR Corp gene
Mini Kit (Qiagen) PCR cycler to IFU
For consumables
EasyScreen™ SARS-CoV-2 Genetic Signatures Ltd and details of
Detection Kit (Australia) componants refer
to IFU

15/54

7500 Fast Dx
For consumables
QIAamp Real-Time PCR
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
96T/kit 7500 Fast Dx

For consumables
Real-Time PCR
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 to IFU
Biosystems)
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
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
to IFU PMDA
Region 2
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
to IFU TGA
Region 2
ORF1ab
For consumables
Region 1
and details of
Aptima SARS-CoV-2/Flu assay 250T/kit Panther System Hologic Inc ORF1ab see IFU see IFU see IFU US FDA EUA
componants refer
Region 2 to IFU
Influenza A/B

16/54

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™)
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
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

17/54

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 Rad) InBios International, ORF1b, and details of
COV2-E 48T/kit see IFU see IFU see IFU componants refer
US FDA EUA
rRT-PCR Kit Inc N and E genes
to IFU
MagMAX
Viral/Pathogen II
Nucleic Acid CFX384 Touch
Isolation Kit Real-Time PCR
Hamilton MagEx Detection System (Bio-
Star automated Rad)
liquid handling
system
KingFisher Flex
For consumables
nucleic acid Applied Biosystems
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 For consumables
Technologies) Jiangsu Bioperfectus 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) to IFU WHO EUL
QIAamp® Viral 7500 Real-Time PCR
RNA instrument (Applied
Mini Kit (Qiagen) Biosystems)
For consumables
Novel Coronavirus (SARS-CoV- 24T/kit 7500 Real-Time PCR
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
and details of
SmartAmp SARS-CoV-2 K.K. DNAFORM see IFU see IFU see IFU PMDA
componants refer
to IFU
For consumables
QIAamp Virus StepOne/StepOnePlus
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)

18/54

CFX96 Real-Time PCR

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 componants refer
Kit genes TGA
Mini Kit (Qiagen) CFX96 Touch Real- and to IFU
Time PCR midturbinate
Detection System (Bio- nasal swab
Rad)
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
24T/kit Disposable Lucira Device Lucira Health, Inc. N genes see IFU see IFU see IFU US FDA EUA
Test Kit componants refer
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
bioMérieux®
NucliSENS®
easyMAG® System Luminex® MAGPIX® For consumables
ORF1ab, N
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 componants refer
Assay Diagnostics, Inc. Health Canada/Interim Order
including xPONENT Gene to IFU
bioMérieux®
EMAG® System

19/54

bioMérieux®
ORF1ab, N
NucliSENS®
Gene and E For consumables
easyMAG® System Luminex® MAGPIX®
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 to IFU
B and RSH
bioMérieux® and others
EMAG® System
For consumables
Luminultra
Genecount Covid-19 Rt-Qpcr and details of
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 componants refer
US FDA EUA
STAR
QIAamp Viral to IFU
Applied Biosystems
RNA Mini Kit
QuantStudio 5
(Qiagen)
Agilent AriaMx RT-

PCR Instruments
Agilent Stratagene
Mx3005P RT-PCR
Instruments

20/54


II
Applied Biosystems
7500 Fast
n/a Dx
For consumables
LumiraDx SARS-CoV-2 RNA and details of
L018180130096 LumiraDx UK Ltd ORF1a Gene see IFU see IFU see IFU componants refer
US FDA EUA
STAR Complete
to IFU
Applied Biosystems
QuantStudio 5
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
BUSGN7102109 SARS-CoV-2 Fluorescent PCR 64T/kit Extraction Kit, Fast Systems with v2.3 Maccura Biotechnology ORF1ab, and details of
see IFU see IFU see IFU componants refer
US FDA EUA
Kit Version software (Applied (USA) LLC N and E genes
Biosystems) to IFU
QIAGEN QIAamp
BUSGN7103109 96T/kit
Viral RNA Mini Kit
EZ1 Virus
Mini Kit v2.0
on
For consumables
EZ1 Advanced 7500 Fast Dx Real-
SARS-CoV-2 DETECTRTM 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)
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

21/54

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
Veri-Q PCR 316 COVID-19

MiCoBioMed Co Ltd see IFU see IFU see IFU TGA
Detection Kit
For consumables
and details of
Smart Gene SARS-CoV-2 Mizuhomedy Co., Ltd. see IFU see IFU see IFU PMDA
componants refer
to IFU
NeuMoDx™ 288 Molecular System For consumables

Nsp2 target
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 to IFU
[500200]
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)
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 componants refer
US FDA EUA
on Technologies, Inc. Gene
(Applied Biosystems) to IFU
QIAsymphony SP
(Qiagen)
CFX96 Real-Time PCR

Instrument (Biorad)

22/54

Applied Biosystems
QIAamp viral RNA
7500 & 7500 Fast Real-
Mini Kit
Time PCR
System RdRp gene, N
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)
7500 Fast Real-Time

PCR
System (Applied
Biosystems)
Duo instrument QuantStudio5 Flex

(Thermo Scientific) (QS5) instrument
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)

23/54

PerkinElmer®
Nucleic Acid
Extraction Kits
(KN0212) and
PreNAT II
(SY61)(software
version 1.00.06).
chemagic™ Viral For consumables

PerkinElmer® New Applied Biosystems PerkinElmer, Inc. / US FDA EUA
DNA/RNA 300 Kit 7500 Real-Time PCR 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
special H96 (CMG- and N gene componants refer
Detection Kit System Lifescience Co Ltd to IFU WHO EUL
1033, CMG-1033-
S)
and chemagic™
360 (2024-0020)
with chemagic™
Rod Head Set 96
(CMG371)
(chemagic MSM I
software version
6.1.0.5)
Thermo Fisher
MiniAmp Thermal
cycler with
IntelliPlexTM 1000
For consumables
πCode Processor
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 componants refer
US FDA EUA
Detection Kit Mini Kit (Qiagen) and E Gene
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

24/54

Applied Biosystems®
7500 Real-Time PCR
System
GXT DNA/RNA
For consumables
Extraction kit Bio-Rad CFX
Z-PATH-COVID-19- COVID-19 genesig® Real- and details of WHO EUL
96T/kit (GenoXtract®, Connect™ Primerdesign Ltd Orf1 ab gene 12 months see IFU see IFU
CE Time PCR assay componants refer TGA
Bruker-HAIN Real-Time PCR to IFU
Lifescience GmbH) Detection
System
Roche® LightCycler
480 II
7500 Real-Time PCR
GXT DNA/RNA System
Extraction kit
(GenoXtract®, For consumables
Z-COVID-19 (US COVID-19 genesig® Real- Bruker-HAIN Bio-Rad CFX and details of
96T/kit
Connect™ Primerdesign Ltd Orf1 ab gene 12 months see IFU see IFU componants refer
US FDA EUA
ONLY) Time PCR assay Lifescience GmbH)
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
Rad) GmbH (Trax E gene and and details of
PCCSKU15261 PhoenixDx® 2019-nCoV 50T/kit 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)

25/54

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
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)
QuantStudio 3 Real-
Time PCR Instrument
(ThermoFisher)
QuantStudio 5 Real-
Time PCR Instrument
(ThermoFisher)
QuantStudio 7 Real-
Time PCR Instrument
(ThermoFisher)

26/54

For consumables
Orf1b poly 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
Quick-RNA Viral CFX384 Touch Real- Quadrant Biosciences saliva swab and details of
#1110 with #1105 Clarifi COVID-19 Test Kit 480T/kit Time Detection RdRp genes see IFU see IFU US FDA EUA
96 Kit Inc. specimen componants refer
System (Biorad) to IFU
QuantStudio 5
instrument (Applied
Biosystems)
Roche MagNA
Pure-96 (MP96)
Mag-Bind Viral For consumables

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

27/54

nasopharyng Quest Diagnostics

eal swabs, Self-Collection Kit
ORF1ab
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 and details of
sputum,
Region 2 componants refer
BAL, and
tracheal to IFU
aspirates
nasopharyng Quest Diagnostics

eal swabs, Self-Collection Kit
ORF1ab
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 and details of
sputum,
Region 2 componants refer
BAL, and
tracheal to IFU
aspirates
Nasopharyng For consumables

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

eal or and details of
M313 Solana SARS-CoV-2 Assay 96T/kit Solana Instrument Quidel Corp. pp1ab see IFU see IFU US FDA EUA
oropharynge componants refer
al specimens to IFU
nasopharyng For consumables

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

Cobas SARS-CoV-2 RT-PCR and details of Health Canada/Interim Order
09175431190 96T/kit cobas 6800/8800 Roche Diagnostics ORF1 a/b see IFU see IFU see IFU
Kit componants refer PMDA
to IFU WHO EUL

28/54

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
to IFU PMDA
and non-
structural
protein gene
of Influenza B
QIAamp Virus
24T/kit RNA Mini Kit (cat.
Novel Coronavirus (2019- # 52904) For consumables
Applied Biosystems
nCoV) Nucleic Acid Diagnostic ORF1ab and N and details of US FDA EUA
S3104E 7500 Real-Time PCR Sansure Bio Tech Inc. see IFU see IFU see IFU
Kit (PCR-Fluorescence genes componants refer TGA
System to IFU
Probing)
48T/kit without Extraction
Viral RNA
ScienCell™ SARS-CoV-2 Isolation Kit
For consumables
Coronavirus Real-time RT- (ScienCell) LightCycler® 96 Real-
RX7038 RdRp gene, N and details of
PCR (RT-qPCR) Detection Kit 96T/kit Time PCR System ScienCell see IFU see IFU see IFU componants refer
US FDA EUA
(RX7048) Gene
(Multiplex option) (Roche) to IFU
QIAamp Virus
RNA Mini Kit
(Qiagen)

29/54

CFX96 Real-Time PCR

Instrument (Biorad)
Applied Biosystems For consumables

QIAamp Virus
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 componants refer
US FDA EUA
Time Detection kit Time PCR genes
(Qiagen) to IFU
System

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
SS-9930 96T/kit Seasun Biomaterials see IFU see IFU see IFU US FDA EUA
Kit DNA/RNA Gene componants refer
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 componants refer
US FDA EUA
Detection Kit Kit (Qiagen) Gene
Applied Biosystems to IFU
7500 Real-Time PCR
System

30/54

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 PANAMAX Viral ORF1ab and N and details of
SS-9940 96T/kit Seasun Biomaterials see IFU see IFU see IFU componants refer
US FDA EUA
Detection Kit PLUS DNA/RNA Gene
Extraction Kit to IFU
performed on the
PANAMAX 48
Nucleic Acid
Extraction System
TOP Viral
DNA/RNA
Extraction Kit

31/54

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

32/54

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

For consumables
QIAamp DSP Viral Real-Time PCR Shanghai Fosun Long
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- For consumables

Shanghai Fosun Long
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) to IFU
2019-nCoV qPCR)
GenAct NE-48
(Shanghai 7500
GeneoDx) For consumables
Novel Coronavirus 2019-nCoV Real-Time PCR Shanghai GeneoDx
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)

33/54

Applied Biosystems
7500 Real-Time PCR
System
nucleic acid
extraction product For consumables
ORF1ab and N
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 to IFU
bio-engineering
Co., Ltd
Tianlong Gentier 96E
Applied Biosystems For consumables

Novel Coronavirus (2019- QIAamp Virus ORF1ab and N
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 componants refer
WHO EUL
Time PCR Co Ltd (China)
PCR Kit (Qiagen) genes to IFU
System
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)
Novel Coronavirus (2019- ORF1ab and N
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
For consumables
RNA/DNA Mini Not required (RT-
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 componants refer
US FDA EUA
Kit Inc. genes
(Thermo Fisher Technology used) to IFU
Scientific)
For consumables
Ampdirect 2019-nCoV and details of
Shimadzu Corporation see IFU see IFU see IFU componants refer
PMDA
detection kit
to IFU

34/54

QIAamp Virus
CFX96 Real-Time PCR
RNA Mini Kit
Instrument (Biorad)
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
For consumables
SolGent Co., Ltd
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
Suzhou Sym-Bio For consumables

PerkinElmer® SARS-CoV-2 Lifescience Co Ltd and details of
Real-time RT-PCR Assay (China) (represented componants refer
by PerkinElmer) to IFU
For consumables
2019-nCoV Fluorescence
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

35/54

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 componants refer
US FDA EUA
Testing Kit EZbead Viral Corp and E genes
to IFU
Extraction Kit with
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 componants refer
WHO EUL
(lyophilized Time PCR
form) platform to IFU
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

36/54

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
For consumables
Scientific Inc
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)
Isolation Kit
(manual) and
automated on
Instrument
Applied Biosystems
7500 Fast Real-Time
PCR
System
Thermo Fisher
For consumables
Scientific Inc
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)
Isolation Kit
(manual) and
automated on
KingFisher™ Flex
Purification System
(KingFisher)

37/54

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
For consumables
TaqPath New Coronavirus Scientific Inc
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)
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
Instrument
Thermo Fisher
For consumables
Scientific Inc
Taqpath COVID-19 High and details of
A49869 (see also Life see IFU see IFU see IFU Health Canada/Interim Order
Throughput Combo Kit componants refer
Technologies to IFU
Corporation)
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 componants refer
US FDA EUA
(Qiagen) genes
CFX96 Touch Real- to IFU
Time PCR
Rad)

38/54

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
Diagnostic Kit for Novel- For consumables

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

For consumables
Novel-Coronavirus (2019- Ustar Biotechnologies
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
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
to IFU
7500 Fast Dx Real-
Time PCR System
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

39/54

For consumables
Wuhan EasyDiagnosis
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- Lab-Aid Virus RNA Xiamen Zeesan Biotech ORF1ab and N and details of
801301 48T/kit see IFU see IFU see IFU US FDA EUA
time PCR) Extraction Kit Co., Ltd. (China) genes componants refer
to IFU
on
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
Viral/Pathogen see IFU see IFU see IFU US FDA EUA
SC-COVID19-100 PCR Test Kit 100T/kit Bioscience Co., Ltd genes componants refer
Nucleic Acid to IFU
Isolation Kit
7500 Fast Dx Real-
automated on
Time PCR System
KingFisher™ Flex
Purification System
(KingFisher)

40/54

MagMAX™
Viral/Pathogen
Nucleic Acid
Bio-Rad CFX96 Touch
Isolation Kit
Real-Time PCR
automated on
Detection System
KingFisher™ Flex
Purification System
(KingFisher)
For consumables
R3011
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 componants refer
Kit Health Canada/Interim Order
R3011-10K to IFU
MagMAX™
Viral/Pathogen
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.

41/54
Version 29
2021-03-19
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 Card Abbott Diagnostics nucleocapsid
195-100 40T/kit n/a see IFU see IFU see IFU Visual read US FDA EUA
Home Test 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
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

42/54
Anticipated
(months)
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
NowCheck COVID-19 Antigen

RG1901DG BioNote Inc see IFU see IFU see IFU see IFU TGA
Test
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
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
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

43/54
Anticipated
(months)
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
GenBody Inc (Korea -

GenBody COVID-19 Ag see IFU see IFU see IFU TGA
Republic of)
InnoScreen COVID-19 Innovation Scientific

Antigen Rapid Test Device Pty Ltd (Australia)
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

44/54
Anticipated
(months)
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
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
VITROS SARS-CoV-2
VITROS Immunodiagnostic
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 US FDA EUA
VITROS 5600/XT 7600 Diagnostics, Inc protein
Reagent Pack
Integrated Systems 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
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
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
Sofia 2 Flu + SARS Antigen Sofia and US FDA EUA
25T/kit Quidel Corporation protein see IFU see IFU see IFU Reader required
FIA Sofia 2 instrument PMDA
antigen and
Influenza A

45/54
Anticipated
(months)
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 Health Canada Interim Order
9901-NCOV-01G n/a (distributed by Roche see IFU see IFU see IFU Visual Read
Test protein TGA
Diagnostics Australia)
antigen
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
HISCL SARS-CoV-2 Ag Assay

Sysmex Corporation see IFU see IFU see IFU PMDA
Kit
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
N/A- NOT APPLICABLE


46/54
Version 29
2021-03-19
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
Anticipated
(months)
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.
as Fastep COVID-19 IgG/IgM (Hangzhou Co., Ltd)
Rapid Test Device

47/54
Anticipated
(months)
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
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
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)

48/54
Anticipated
(months)
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

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.
RightSign™ COVID-19
Hangzhou Biotest
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.
COVID-19 IgG/IgM Rapid Test Hangzhou Clongene

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
Combo Test Kit (Colloidal
Gold)

49/54
Anticipated
(months)
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

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)
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
Scientific International Phase Scientific
Limited International Limited

50/54
Anticipated
(months)
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)
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

Antibody Rapid Test Biotech Co Ltd (China)

51/54
Anticipated
(months)
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
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
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

52/54
Anticipated
(months)
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

GCCOV-402a Test Cassette Biotech Co Ltd (China)
Zhongshan Chuangyi
COVID-19 IgG/IgM Rapid Test Biochemical
Kit Engineering Co Ltd
(China)
N/A- NOT APPLICABLE


53/54
Version 29
2021-03-19
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
RT-PCR IVD MEDICAL DEVICE FOR 2019 NOVEL

CORONAVIRUS (SARS-COV-2) NUCLEIC ACID HA TECH PTY LTD Feb-20 TGA delisted
DETECTION
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 IgG SGTi-flex COVID-19 IgG 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
LIST OF DIAGNOSTIC PRODUCTS-DELISTED PRODUCTS 54/54

Covid19 Diagnosticproducts List en

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Version 29

SARS-CoV-2 Nuclear Acid Amplification Technologies

Platform Platform Anticipated

Applied Biosystems 1DROP INC. (imported For consumables

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to

Platform Platform Anticipated

For consumables US FDA EUA

RdRp and N For consumables

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to

Platform Platform Anticipated

CFX96™ Touch Real-

QIAamp® Viral Applied Biosystems

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to

Platform Platform Anticipated

Zymo Quick-RNA CFX96™ Touch Real-

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to

Platform Platform Anticipated

TIANamp Virus Applied Biosystems

QIAamp Viral RNA CFX96 Touch Real-

High Pure Viral

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to

Platform Platform Anticipated

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to

Platform Platform Anticipated

CFX96 Touch Real-

CFX96 Touch Real- For consumables

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to

Platform Platform Anticipated

423745 6T/kit For consumables

S Gene, M For consumables

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to

Platform Platform Anticipated

7500 & 7500 Fast Real-

CFX96 Touch Real-

MagNA Pure 96 Rotor‑Gene Q

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to

Platform Platform Anticipated

CFX96 Touch (Biorad)

P and N genes For consumables

7500 Real-Time PCR

7500 Fast Real-Time

CFX96 Real-Time PCR

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to

Platform Platform Anticipated

GeneXpert Dx For consumables US FDA EUA

Thermo 7500 Real-Time PCR

CFX96 Touch Real- For consumables

96S Real-Time PCR

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to

Platform Platform Anticipated

Clear Dx™ system

7500 Fast Real-Time

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to

Platform Platform Anticipated

Thermo Fisher Applied Biosystems™

For consumables US FDA EUA

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to

Platform Platform Anticipated

GENFLEX platform V1.0

List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to

Platform Platform Anticipated

Biomark HD in Conjunction with Juno or

CFX96 Touch Real-