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

5 June 2020

The TGA has approved the following tests for inclusion in 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 (the Doherty Institute) has been engaged by the Department of Health to assist with the post-market validation of new COVID-19 rapid tests to inform their best use.

Only the approved Sponsor (i.e. importer) listed in the table below, or a person acting on their behalf (ie, the person has a distribution arrangement with the sponsor), can supply the device.

*Note: Some point-of-care tests are not intended for use with finger-prick (finger-stick) specimens. Please refer to the instructions for use for each test to determine intended specimen types.

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

Displaying 1 - 61 of 61

Laboratory

Nucleic Acid Test

Manufacturer: Abbott Australasia Pty Ltd Molecular Division

Name of test: Abbott RealTime SARS-CoV-2

Australian sponsor: Abbott Australasia Pty Ltd Molecular Division

Date approved for supply: 17 Apr 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Atlaslink Beijing Technology Co Ltd (China)

Name of test: NOVA Test® COVID-19 IgG/IgM Antibody Test (Colloidal Gold)

Australian sponsor: Adelco Pharmaceuticals (Australia) Pty Ltd

Date approved for supply: 18 May 2020

Laboratory

Nucleic Acid Test

Manufacturer: AusDiagnostics Pty Ltd (Australia)

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

Australian sponsor: AusDiagnostics Pty Ltd

Date approved for supply: 19 Mar 2020

Laboratory

Nucleic Acid Test

Manufacturer: Becton Dickinson and Company (United States Of America)

Name of test: BD SARS-CoV-2 Reagents for BD MAX™ System

Australian sponsor: Becton Dickinson Pty Ltd

Date approved for supply: 17 Apr 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Beijing Wantai Biologicalpharmacy Enterprise Co Ltd (China)

Name of test: Wantai SARS-CoV-2 Ab Rapid Test kit

Australian sponsor: Life Clinic Australia Pty Ltd

Date approved for supply: 27 Mar 2020

Laboratory

Nucleic Acid Test

Manufacturer: BGI Europe A/S (Denmark)

Name of test: Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2

Australian sponsor: BGI Health (AU) Company Pty Ltd

Date approved for supply: 10 Apr 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Cellex Inc (United States Of America)

Name of test: Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test kit

Australian sponsor: Medicision Pty Ltd

Date approved for supply: 31 Mar 2020

Laboratory/Point-of-care test*

Nucleic Acid Test

Manufacturer: Cepheid (USA)

Name of test: Xpert® Xpress SARS-CoV-2

Australian sponsor: Cepheid Holdings Pty Ltd

Date approved for supply: 22 Mar 2020

Laboratory

Nucleic Acid Test

Manufacturer: CerTest Biotec SL (Spain)

Name of test: VIASURE SARS-CoV-2 Real Time PCR Detection Kit

Australian sponsor: Abacus dx Pty Ltd

Date approved for supply: 31 Mar 2020

Laboratory

Nucleic Acid Test

Manufacturer: CerTest Biotec SL (Spain)

Name of test: VIASURE SARS-CoV-2 S gene Real Time PCR Detection Kit

Australian sponsor: Becton Dickinson Pty Ltd

Date approved for supply: 21 Mar 2020

Laboratory

Nucleic Acid Test

Manufacturer: CTK Biotech Inc (United States Of America)

Name of test: Aridia COVID-19 Real-Time PCR Test

Australian sponsor: MD Solutions Australasia Pty Ltd

Date approved for supply: 24 Apr 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: CTK Biotech Inc (USA)

Name of test: OnSite COVID-19 IgG/IgM Rapid Test

Australian sponsor: MD Solutions Australasia Pty Ltd

Date approved for supply: 19 Mar 2020

Laboratory

Immunoassay

Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG (Germany)

Name of test: Anti-SARS-CoV-2 ELISA (IgA)

Australian sponsor: ESL Biosciences Australia 2012 Pty Ltd

Date approved for supply: 18 May 2020

Laboratory

Immunoassay

Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG (Germany)

Name of test: Anti-SARS-CoV-2 ELISA (IgG)

Australian sponsor: ESL Biosciences Australia 2012 Pty Ltd

Date approved for supply: 18 May 2020

Laboratory

Nucleic Acid Test

Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG (Germany)

Name of test: EURORealTime SARS-CoV-2

Australian sponsor: ESL Biosciences Australia 2012 Pty Ltd

Date approved for supply: 18 May 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: GenBody Inc (Korea - Republic of)

Name of test: GenBody COVID-19 IgM/IgG

Australian sponsor: Biovent Consulting Pty Ltd

Date approved for supply: 28 Apr 2020

Laboratory

Nucleic Acid Test

Manufacturer: Genetic Signatures Ltd (Australia)

Name of test: EasyScreen™ SARS-CoV-2 Detection Kit

Australian sponsor: Genetic Signatures Ltd

Date approved for supply: 13 Apr 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Guangzhou Wondfo Biotech Co Ltd (China)

Name of test: SARS-CoV-2 Antibody Test (Lateral Flow Method)

Australian sponsor: Allsafe Medical Pty Ltd

Date approved for supply: 17 Apr 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Guangzhou Wondfo Biotech Co Ltd (China)

Name of test: SARS-CoV-2 Antibody Test (Lateral Flow Method)

Australian sponsor: Tayler Dental Consulting Pty Ltd

Date approved for supply: 9 Apr 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Guanngzhou Wondfo Biotech Co Ltd (China)

Name of test: SARS-CoV-2 Antibody Test (Lateral Flow Method)

Australian sponsor: Cellmid Limited

Date approved for supply: 25 Mar 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Hangzhou Alltest Biotech Co Ltd (China)

Name of test: 2019-n-CoV IgG/IgM Rapid Test Cassette

Australian sponsor: AM Diagnostics

Date approved for supply: 23 Mar 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Hangzhou Biotest Biotech Co Ltd (China)

Name of test: COVID-19 IgG/IgM Rapid Test Cassette

Australian sponsor: Medsupply Australia Pty Ltd

Date approved for supply: 4 Apr 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Hangzhou Clongene Biotech Co Ltd (China)

Name of test: COVID-19 IgG/IgM Rapid Test Cassette

Australian sponsor: APAC Security Pty Ltd

Date approved for supply: 26 Mar 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Hangzhou Clongene Biotech Co Ltd (China)

Name of test: COVID-19 IgG/IgM Rapid Test Cassette

Australian sponsor: Ausliance Group Pty Ltd

Date approved for supply: 4 Apr 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Hangzhou Clongene Biotech Co Ltd (China)

Name of test: COVID-19 IgG/IgM Rapid Test Cassette

Australian sponsor: Zenpharm Pty Ltd

Date approved for supply: 6 Apr 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Hangzhou Laihe Biotech Co Ltd (China)

Name of test: Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)

Australian sponsor: Complementary Medicines Group Pty Ltd

Date approved for supply: 6 Apr 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Hangzhou Realy Tech Co Ltd (China)

Name of test: 2019-nCOV/COVID-19 IgG/IgM Rapid Test Device

Australian sponsor: Solasta Life Pty Ltd

Date approved for supply: 16 Apr 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Healgen Scientific Limited Liability Company (United States Of America)

Name of test: COVID-19 IgG/IgM Rapid Test Cassette

Australian sponsor: Southwind International Pty Ltd

Date approved for supply: 29 Apr 2020

Laboratory

Nucleic Acid Test

Manufacturer: Hologic Inc (USA)

Name of test: Panther Fusion® SARS-CoV-2 Assay (Panther Fusion® System)

Australian sponsor: Hologic (Australia & New Zealand) Pty Ltd

Date approved for supply: 20 Mar 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Innovation Scientific Pty Ltd (Australia)

Name of test: InnoScreenTM COVID-19 IgG/IgM Rapid Test

Australian sponsor: Innovation Scientific Pty Ltd

Date approved for supply: 11 May 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Innovita (Tangshan) Biological Technology Co Ltd (China)

Name of test: 2019-nCoV Ab Test (Colloidal Gold)

Australian sponsor: AM Diagnostics

Date approved for supply: 20 Apr 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Innovita (Tangshan) Biological Technology Co Ltd (China)

Name of test: 2019-nCoV Ab Test (Colloidal Gold)

Australian sponsor: Aurora Future Education Group

Date approved for supply: 4 Apr 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Innovita (Tangshan) Biological Technology Co Ltd (China)

Name of test: 2019-nCov Ab Test (Colloidal Gold)

Australian sponsor: Laser Corporation Holdings Pty Limited

Date approved for supply: 16 Apr 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Innovita (Tangshan) Biological Technology Co Ltd (China)

Name of test: 2019-nCoV Ab Test (Colloidal Gold)

Australian sponsor: TrendBio Pty Ltd

Date approved for supply: 11 Apr 2020

Laboratory

Nucleic Acid Test

Manufacturer: Jiangsu Bioperfectus Technologies Co Ltd (China)

Name of test: COVID-19 Coronavirus Real Time PCR Kit

Australian sponsor: Sonictec

Date approved for supply: 5 May 2020

Laboratory

Nucleic Acid Test

Manufacturer: Kogene Biotech Co Ltd (Korea - Republic of)

Name of test: PowerChekTM 2019-nCoV Real-time PCR Kit

Australian sponsor: World Systems Corporation Pty Ltd

Date approved for supply: 16 Apr 2020

Laboratory

Nucleic Acid Test

Manufacturer: Life Technologies Corporation (USA)

Name of test: TaqPath COVID-19 Combo Kit

Australian sponsor: Life Technologies Australia Pty Ltd

Date approved for supply: 24 Mar 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Nantong Egens Biotechnology Co Ltd (China)

Name of test: COVID-19 IgG/IgM Rapid Test Kit

Australian sponsor: Lavinia Medical Pty Ltd

Date approved for supply: 27 May 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: NTBIO Diagnostics Inc (Canada)

Name of test: NTBIO One Step Rapid Test - COVID-19 IgG/IgM Antibody Test

Australian sponsor: Healtheguru Pty Ltd

Date approved for supply: 27 May 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: PCL Inc (Korea - Republic of)

Name of test: PCL COVID19 IgG/IgM Rapid Gold

Australian sponsor: Haemokinesis Pty Ltd

Date approved for supply: 1 May 2020

Laboratory

Nucleic Acid Test

Manufacturer: Qiagen GmbH

Name of test: QIAstat-Dx® Respiratory SARS-CoV-2 Panel

Australian sponsor: Qiagen Pty Ltd

Date approved for supply: 8 May 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Qingdao Hightop Biotech Co Ltd (China)

Name of test: SARS-CoV-2 IgM/IgG Antibody Rapid Test

Australian sponsor: Envon Pty Ltd

Date approved for supply: 31 Mar 2020

Laboratory

Immunoassay

Manufacturer: Roche Diagnostics GmbH (Germany)

Name of test: Elecsys Anti-SARS-CoV-2

Australian sponsor: Roche Diagnostics Australia Pty Limited

Date approved for supply: 20 May 2020

Laboratory

Nucleic Acid Test

Manufacturer: Roche Molecular Systems Inc (USA)

Name of test: cobas® SARS-CoV-2

Australian sponsor: Roche Diagnostics Australia Pty Limited

Date approved for supply: 20 Mar 2020

Laboratory

Nucleic Acid Test

Manufacturer: Seegene Inc (Korea - Republic of)

Name of test: Allplex™ 2019-nCoV Assay

Australian sponsor: Integrated Sciences Pty Ltd

Date approved for supply: 27 Mar 2020

Laboratory

Nucleic Acid Test

Manufacturer: Shanghai Fosun Long March Medical Science Co Ltd (China)

Name of test: Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit

Australian sponsor: Alma Lasers Australia Pty Ltd

Date approved for supply: 8 May 2020

Laboratory

Nucleic Acid Test

Manufacturer: Shanghai ZJ Bio-Tech Co Ltd (China)

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

Australian sponsor: Icon International Pty Ltd t/a Icon Medipharm

Date approved for supply: 22 Mar 2020

Laboratory

Immunoassay

Manufacturer: Siemens Healthcare Diagnostics Inc (United States Of America)

Name of test: ADVIA Centaur® SARS-CoV-2 Total (COV2T) assay

Australian sponsor: Siemens Healthcare Pty Ltd

Date approved for supply: 5 Jun 2020

Laboratory

Immunoassay

Manufacturer: Siemens Healthcare Diagnostics Inc (United States Of America)

Name of test: Atellica® IM SARS-CoV-2 Total (COV2T) assay

Australian sponsor: Siemens Healthcare Pty Ltd

Date approved for supply: 5 Jun 2020

Laboratory

Nucleic Acid Test

Manufacturer: Suzhou Sym-Bio Lifescience Co Ltd (China)

Name of test: PerkinElmer® SARS-CoV-2 Real-time RT-PCR Assay

Australian sponsor: PerkinElmer

Date approved for supply: 2 Jun 2020

Laboratory/Point-of-care test*

Nucleic Acid Test

Manufacturer: Ustar Biotechnologies (Hangzhou) Co Ltd (China)

Name of test: EasyNat Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay)

Australian sponsor: EHEALTHY PTY LTD

Date approved for supply: 23 Apr 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: VivaCheck Biotech (Hangzhou) Co Ltd (China)

Name of test: VivaDiag™ COVID-19 IgM/IgG Rapid Test

Australian sponsor: Endo X Pty Ltd

Date approved for supply: 20 Mar 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: VivaChek Biotech (Hangzhou) Co Ltd (China)

Name of test: VivaDiag™ COVID-19 IgM/IgG Rapid Test

Australian sponsor: Device Technologies Australia Pty Ltd

Date approved for supply: 26 Mar 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: VivaChek Biotech (Hangzhou) Co Ltd (China)

Name of test: VivaDiag™ COVID-19 IgM/IgG Rapid Test

Australian sponsor: Stonestar Wholesale Pty Ltd

Date approved for supply: 6 Apr 2020

Laboratory

Nucleic Acid Test

Manufacturer: Wuhan EasyDiagnosis Biomedicine Co Ltd (China)

Name of test: COVID-19 (SARS-CoV-2) Nucleic Acid Test kit

Australian sponsor: Australian Trefoil Health Technologies Pty Ltd

Date approved for supply: 19 May 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Wuhan EasyDiagnosis Biomedicine Co Ltd (China)

Name of test: SARS-CoV-2 IgM/IgG Antibody Test Kit

Australian sponsor: Australian Trefoil Health Technologies Pty Ltd

Date approved for supply: 19 May 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Zhejiang Orient Gene Biotech Co Ltd (China)

Name of test: COVID 19 IgG/IgM Rapid Test Cassette

Australian sponsor: Expia Pty Ltd

Date approved for supply: 24 Apr 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Zhejiang Orient Gene Biotech Co Ltd (China)

Name of test: COVID-19 IgG/IgM Rapid Test Cassette

Australian sponsor: Amandla China Pty Limited

Date approved for supply: 1 Apr 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Zhejiang Orient Gene Biotech Co Ltd (China)

Name of test: COVID-19 IgG/IgM Rapid Test Cassette

Australian sponsor: Onsite Diagnostics Pty Ltd

Date approved for supply: 14 Apr 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Zhuhai Livzon Diagnostics Inc (China)

Name of test: Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow)

Australian sponsor: Emergence Technology Pty Ltd

Date approved for supply: 5 May 2020

Point-of-care test*

Lateral Flow IgG/IgM

Manufacturer: Zhuhai Livzon Diagnostics Inc (China)

Name of test: Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow)

Australian sponsor: Marcel Equity Pty Limited/Avania PL

Date approved for supply: 23 Apr 2020