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COVID-19 test kits included on the ARTG for legal supply in Australia

4 April 2020

The TGA has approved the following tests for inclusion on the Australian Register of Therapeutic Goods (ARTG).

Please note: Conditions have been imposed on the supply of COVID-19 serology-based point of care tests. Further information can be found at: Legal supply of COVID-19 test kits. The Peter Doherty Institute for Infection and Immunity has also been funded to undertake a post-market assessment of new COVID-19 rapid tests to inform their best use.

Name of Test Laboratory or POCT* Type of Test Australian Sponsor/Supplier** Manufacturer Date Approved for Supply

2019-nCoV Ab Test (Colloidal Gold)

POCT

Lateral Flow IgG/IgM

Aurora Future Education Group

Innovita (Tangshan) Biological Technology Co Ltd (China)

4 April 2020

2019-n-CoV IgG/IgM Rapid Test Cassette

POCT

Lateral Flow IgG/IgM

AM Diagnostics - DC

Hangzhou Alltest Biotech Co Ltd (China)

23 March 2020

Allplex™ 2019-nCoV Assay

Laboratory

Nucleic Acid Test

Integrated Sciences Pty Ltd

Seegene Inc (Korea - Republic of)

27 March 2020

AusDiagnostics respiratory virus panel (including SARS-CoV-2) test

Laboratory

Nucleic Acid Test

AusDiagnostics Pty Ltd

AusDiagnostics Pty Ltd (Australia)

19 March 2020

Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test kit

POCT

Lateral Flow IgG/IgM

MEDICISION PTY LTD

Cellex Inc (United States Of America)

31 March 2020

cobas® SARS-CoV-2

Laboratory

Nucleic Acid Test

Roche Diagnostics Australia Pty Limited

Roche Molecular Systems Inc (USA)

20 March 2020

COVID-19 IgG/IgM Rapid Test Cassette

POCT

Lateral Flow IgG/IgM

Amandla China Pty Limited

Zhejiang Orient Gene Biotech Co Ltd (China)

1 April 2020

COVID-19 IgG/IgM Rapid Test Cassette

POCT

Lateral Flow IgG/IgM

APAC Security Pty Ltd

Hangzhou Clongene Biotech Co Ltd (China)

26 March 2020

COVID-19 IgG/IgM Rapid Test Cassette

POCT

Lateral Flow IgG/IgM

Ausliance Group Pty Ltd

Hangzhou Clongene Biotech Co Ltd (China)

4 April 2020

COVID-19 IgG/IgM Rapid Test Cassette

POCT

Lateral Flow IgG/IgM

Medsupply Australia Pty Ltd

HANGZHOU BIOTEST BIOTECH NO LTD (China)

4 April 2020

Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit (Detection for 3 genes)

Laboratory

Nucleic Acid Test

Icon International Pty Ltd t/a Icon Medipharm

Shanghai ZJ Bio-Tech Co Ltd (China)

22 March 2020

OnSite COVID-19 IgG/IgM Rapid Test

POCT

Lateral Flow IgG/IgM

MD Solutions Australasia Pty Ltd

CTK Biotech Inc (USA)

19 March 2020

Panther Fusion® SARS-CoV-2 Assay (Panther Fusion® System)

Laboratory

Nucleic Acid Test

Hologic (Australia & New Zealand) Pty Ltd

Hologic Inc (USA)

20 March 2020

SARS-CoV-2 Antibody Test (Lateral Flow Method)

POCT

Lateral Flow IgG/IgM

Advangen International Pty Ltd

Guangzhou Wondfo Biotech Co Ltd (China)

25 March 2020

SARS-CoV-2 IgM/IgG Antibody Rapid Test

POCT

Lateral Flow IgG/IgM

Envon Pty Ltd

Qingdao Hightop Biotech Co Ltd (China)

31 March 2020

TaqPath COVID-19 Combo Kit

Laboratory

Nucleic Acid Test

Life Technologies Australia Pty Ltd

Life Technologies Corporation (USA)

24 March 2020

VIASURE SARS-CoV-2 Real Time PCR Detection Kit

Laboratory

Nucleic Acid Test

Abacus dx Pty Ltd

CerTest Biotec SL (Spain)

31 March 2020

VIASURE SARS-CoV-2 S gene Real Time PCR Detection Kit

Laboratory

Nucleic Acid Test

Becton Dickinson Pty Ltd

CerTest Biotec SL (Spain)

21 March 2020

VivaDiag™ COVID-19 IgM/IgG Rapid Test

POCT

Lateral Flow IgG/IgM

Device Technologies Australia Pty Ltd

VivaChek Biotech (Hangzhou) Co Ltd (China)

26 March 2020

VivaDiag™ COVID-19 IgM/IgG Rapid Test

POCT

Lateral Flow IgG/IgM

Endo X Pty Ltd

VivaCheck Biotech (Hangzhou) Co Ltd (China)

20 March 2020

Wantai SARS-CoV-2 Ab Rapid Test kit

POCT

Lateral Flow IgG/IgM

Life Clinic Australia Pty Ltd

Beijing Wantai Biologicalpharmacy Enterprise Co Ltd (China)

27 March 2020

Xpert® Xpress SARS-CoV-2

Laboratory/POCT

Nucleic Acid Test

Cepheid Holdings Pty Ltd

Cepheid (USA)

22 March 2020

*POCT is a Point of Care Test.

**Only the Sponsor/Supplier listed in the table above, or a person acting on their behalf (i.e., the person has a distribution arrangement with the sponsor/supplier), can supply the device.