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COVID-19 test kits included in the ARTG for legal supply in Australia
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
- Category:Medical devices/IVDs
- Tags:medical devices, COVID-19 tests
- URL:https://www.tga.gov.au/node/904122