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COVID-19 test kits included in the ARTG for legal supply in Australia
13 January 2021
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 and rapid antigen 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 - 120 of 120
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*
Nucleic Acid Test
Manufacturer: Abbott Diagnostics Scarborough Inc also d/b/a Alere Scarborough Inc (United States Of America)
Name of test: ID NOW COVID-19
Australian sponsor: Abbott Rapid Diagnostics Pty Ltd
Date approved for supply: 7 Oct 2020
Laboratory
Immunoassay
Manufacturer: Abbott Ireland Diagnostic Division (Ireland)
Name of test: SARS-CoV-2 IgM Kit
Australian sponsor: Abbott Australasia Pty Ltd Diagnostic Division
Date approved for supply: 17 Sep 2020
Laboratory
Immunoassay
Manufacturer: Abbott Ireland Diagnostic Division (Ireland)
Name of test: SARS-CoV-2 IgG Kit
Australian sponsor: Abbott Australasia Pty Ltd Diagnostic Division
Date approved for supply: 28 Jul 2020
Laboratory
Nucleic Acid Test
Manufacturer: Abbott Molecular Inc (United States Of America)
Name of test: Alinity m SARS-CoV-2 AMP Kit
Australian sponsor: Abbott Australasia Pty Ltd Molecular Division
Date approved for supply: 27 Aug 2020
Point-of-care test*
Antigen Test
Manufacturer: Abbott Rapid Diagnostics Jena GmbH (Germany)
Name of test: Panbio™ COVID-19 Ag Rapid Test Device
Australian sponsor: Abbott Rapid Diagnostics Pty Ltd
Date approved for supply: 30 Sep 2020
Laboratory
Nucleic Acid Test
Manufacturer: Accelerate Technologies Pte Ltd (DxD Hub) (Singapore)
Name of test: Resolute 2.0 SARS CoV-2 Detection Kit
Australian sponsor: Accelagen Pty Ltd
Date approved for supply: 13 Jan 2021
Point-of-care test*
Antigen Test
Manufacturer: Access Bio Inc (United States Of America)
Name of test: Atomo Covid-19 Antigen Test
Australian sponsor: Atomo Diagnostics Limited
Date approved for supply: 26 Oct 2020
Point-of-care test*
Antigen Test
Manufacturer: Access Bio Inc (United States Of America)
Name of test: CareStart™ COVID-19 Antigen
Australian sponsor: Pantonic Health Pty Ltd
Date approved for supply: 15 Sep 2020
Laboratory
Nucleic Acid Test
Manufacturer: Access Bio Inc (United States Of America)
Name of test: CareStart™ COVID-19 MDx RT-PCR
Australian sponsor: Pantonic Health Pty Ltd
Date approved for supply: 27 Aug 2020
Point-of-care test*
Antigen Test
Manufacturer: Assure Tech (Hangzhou) Co Ltd (China)
Name of test: COVID-19 Antigen Rapid Test Device
Australian sponsor: Emergence Technology Pty Ltd
Date approved for supply: 27 Oct 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
Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Atomo Diagnostics Limited (Australia)
Name of test: AtomoRapid™ COVID-19 IgM/IgG Antibody Test
Australian sponsor: Atomo Diagnostics Limited
Date approved for supply: 12 Aug 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
Immunoassay
Manufacturer: Beckman Coulter Inc (United States Of America)
Name of test: Access SARS-CoV-2 IgG Antibody Test
Australian sponsor: Beckman Coulter Australia Pty Ltd
Date approved for supply: 24 Jul 2020
Point-of-care test*
Antigen Test
Manufacturer: Becton Dickinson and Company (United States Of America)
Name of test: BD Veritor™ System for Rapid Detection of SARS-CoV-2
Australian sponsor: Becton Dickinson Pty Ltd
Date approved for supply: 22 Sep 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: Suretest (formerly Life Clinic Australia Pty Ltd)
Date approved for supply: 27 Mar 2020
Laboratory
Immunoassay
Manufacturer: Beijing Wantai Biologicalpharmacy Enterprise Co Ltd (China)
Name of test: Wantai SARS-CoV-2 Ab ELISA
Australian sponsor: Suretest (formerly Life Clinic Australia Pty Ltd)
Date approved for supply: 30 Sep 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
Laboratory
Immunoassay
Manufacturer: Bio-Rad (France)
Name of test: Platelia SARS-CoV-2 Total Ab
Australian sponsor: Bio-Rad Laboratories Pty Ltd
Date approved for supply: 23 Jun 2020
Laboratory
Nucleic Acid Test
Manufacturer: BioCore Co Ltd (Korea - Republic of)
Name of test: Bio-Core 2019-nCoV Real Time PCR Kit
Australian sponsor: Joy Surgical Pty Ltd
Date approved for supply: 21 Jul 2020
Laboratory
Nucleic Acid Test
Manufacturer: BioFire Diagnostics LLC
Name of test: BioFire Respiratory Panel 2.1 plus (RP2.1plus)
Australian sponsor: Biomerieux Australia Pty Ltd
Date approved for supply: 27 Jul 2020
Laboratory
Antigen Test
Manufacturer: BIOHIT HealthCare (Hefei) Co Ltd (China)
Name of test: SARS-CoV-2 Antigen Quantitative Assay Kit (Enzyme-linked Immunoassay)
Australian sponsor: Hough Pharma Pty Ltd
Date approved for supply: 29 Sep 2020
Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: BIOHIT HealthCare (Hefei) Co Ltd (China)
Name of test: SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold Method)
Australian sponsor: Hough Pharma Pty Ltd
Date approved for supply: 29 Sep 2020
Laboratory/Point-of-care test*
Antigen Test
Manufacturer: BIOHIT HealthCare (Hefei) Co Ltd (China)
Name of test: SARS-CoV-2 Antigen Rapid Test Kit (updated 6 January 2021)
Australian sponsor: Hough Pharma Pty Ltd
Date approved for supply: 19 Oct 2020
Laboratory
Immunoassay
Manufacturer: Biomerieux SA (France)
Name of test: VIDAS® SARS-COV-2 IgG
Australian sponsor: Biomerieux Australia Pty Ltd
Date approved for supply: 3 Aug 2020
Laboratory
Nucleic Acid Test
Manufacturer: Biomerieux SA (France)
Name of test: SARS-COV-2 R-GENE®
Australian sponsor: Biomerieux Australia Pty Ltd
Date approved for supply: 3 Aug 2020
Laboratory
Immunoassay
Manufacturer: Biomerieux SA (France)
Name of test: VIDAS® SARS-COV-2 IgM
Australian sponsor: Biomerieux Australia Pty Ltd
Date approved for supply: 3 Aug 2020
Point-of-care test*
Antigen Test
Manufacturer: BioNote Inc (Korea - Republic of)
Name of test: NowCheck COVID-19 Antigen Test
Australian sponsor: Life Bioscience Pty Ltd
Date approved for supply: 11 Sep 2020
Point-of-care test*
Antigen Test
Manufacturer: BTNX Inc (Canada)
Name of test: COVID-19 Antigen Rapid Test Cassette
Australian sponsor: SureScreen Australia Pty Limited
Date approved for supply: 3 Nov 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 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: 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: Co-Diagnostics Inc (United States Of America)
Name of test: Logix Smart™ Coronavirus Disease 2019 (COVID-19) Kit
Australian sponsor: Gene Target Solutions Pty Ltd
Date approved for supply: 4 Aug 2020
Laboratory
Nucleic Acid Test
Manufacturer: Coyote Bioscience Co Ltd (China)
Name of test: DirectDetect™ SARS-CoV-2 Detection Kit
Australian sponsor: Marcel Equity Pty Limited
Date approved for supply: 9 Oct 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 / Aria COVID-19 IgG/IgM Rapid Test (updated 16 Sep 2020)
Australian sponsor: MD Solutions Australasia Pty Ltd
Date approved for supply: 19 Mar 2020
Laboratory
Nucleic Acid Test
Manufacturer: Da An Gene Co Ltd of Sun Yat-sen University (China)
Name of test: Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing)
Australian sponsor: The Trustee for LILY CO UNIT TRUST
Date approved for supply: 7 Sep 2020
Laboratory
Nucleic Acid Test
Manufacturer: DiaSorin Molecular LLC (United States Of America)
Name of test: Simplexa™ COVID-19 Direct
Australian sponsor: DiaSorin Australia Pty Ltd
Date approved for supply: 4 Aug 2020
Laboratory
Immunoassay
Manufacturer: DiaSorin SpA (Italy)
Name of test: LIAISON® SARS-CoV-2 IgM
Australian sponsor: DiaSorin Australia Pty Ltd
Date approved for supply: 31 Jul 2020
Laboratory
Immunoassay
Manufacturer: DiaSorin SpA (Italy)
Name of test: LIAISON® SARS-CoV-2 S1/S2 IgG
Australian sponsor: DiaSorin Australia Pty Ltd
Date approved for supply: 31 Jul 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
Laboratory
Immunoassay
Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG (Germany)
Name of test: Anti-SARS-CoV-2 NCP ELISA (IgG)
Australian sponsor: ESL Biosciences Australia 2012 Pty Ltd
Date approved for supply: 5 Aug 2020
Laboratory
Immunoassay
Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG (Germany)
Name of test: Anti-SARS-CoV-2 NCP ELISA (IgM)
Australian sponsor: ESL Biosciences Australia 2012 Pty Ltd
Date approved for supply: 5 Aug 2020
Laboratory
Immunoassay
Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG (Germany)
Name of test: Anti-SARS-CoV-2 QuantiVac ELISA (IgG)
Australian sponsor: ESL Biosciences Australia 2012 Pty Ltd
Date approved for supply: 23 Dec 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
Point-of-care test*
Antigen Test
Manufacturer: GenBody Inc (Korea - Republic of)
Name of test: GenBody COVID-19 Ag
Australian sponsor: Nature's Family Australia Pty Ltd
Date approved for supply: 27 Nov 2020
Laboratory
Nucleic Acid Test
Manufacturer: General Biologicals Corp (Taiwan)
Name of test: GB SARS-CoV-2 Real Time RT-PCR
Australian sponsor: Labtest Medical Pty Ltd
Date approved for supply: 25 Jun 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
Laboratory
Nucleic Acid Test
Manufacturer: HA TECH PTY LTD (Australia)
Name of test: RT-PCR IVD MEDICAL DEVICE FOR 2019 NOVEL CORONAVIRUS (SARS-COV-2) NUCLEIC ACID DETECTION
Australian sponsor: HA TECH PTY LTD
Date approved for supply: 14 Dec 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 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 (United States Of America)
Name of test: Aptima® SARS-CoV-2 Assay
Australian sponsor: Hologic (Australia & New Zealand) Pty Ltd
Date approved for supply: 29 Jun 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: InnoScreen™ COVID-19 IgG/IgM Rapid Test
Australian sponsor: Innovation Scientific Pty Ltd
Date approved for supply: 11 May 2020
Point-of-care test*
Antigen Test
Manufacturer: Innovation Scientific Pty Ltd (Australia)
Name of test: InnoScreen COVID-19 Antigen Rapid Test Device
Australian sponsor: Innovation Scientific Pty Ltd
Date approved for supply: 19 Oct 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
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: PowerChek™ 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: Labgenomics Co Ltd (Korea - Republic of)
Name of test: LabGun™ COVID-19 RT-PCR Kit
Australian sponsor: Viso Aesthetics Pty Ltd
Date approved for supply: 23 Jun 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
Laboratory/Point-of-care test*
Nucleic Acid Test
Manufacturer: MiCoBioMed Co Ltd (Korea - Republic of)
Name of test: Veri-Q PCR 316 COVID-19 Detection Kit
Australian sponsor: Covid Solutions Pty Ltd
Date approved for supply: 1 Sep 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
Laboratory
Nucleic Acid Test
Manufacturer: NeuMoDx Molecular Inc (United States Of America)
Name of test: NeuMoDx™ SARS-CoV-2 Assay
Australian sponsor: Qiagen Pty Ltd
Date approved for supply: 10 Sep 2020
Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Newscen Coast Bio-Pharmaceutical Co Ltd (China)
Name of test: COVID-19 IgG/IgM Rapid Test Cassette
Australian sponsor: Kissun Pharmaceuticals Pty Ltd
Date approved for supply: 23 Jun 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
Laboratory
Immunoassay
Manufacturer: Ortho-Clinical Diagnostics (United Kingdom)
Name of test: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG
Australian sponsor: Ortho-Clinical Diagnostics Australia Pty Ltd
Date approved for supply: 26 Oct 2020
Laboratory
Immunoassay
Manufacturer: Ortho-Clinical Diagnostics (United Kingdom)
Name of test: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total
Australian sponsor: Ortho-Clinical Diagnostics Australia Pty Ltd
Date approved for supply: 19 Jun 2020
Laboratory
Nucleic Acid Test
Manufacturer: OSANG Healthcare Co Ltd (Korea - Republic of)
Name of test: GeneFinder™ COVID-19 Plus RealAmp Kit
Australian sponsor: Elitechgroup Australia Pty Ltd
Date approved for supply: 24 Jul 2020
Laboratory
Nucleic Acid Test
Manufacturer: Primer Design Limited (United Kingdom)
Name of test: genesig® Real-Time PCR Coronavirus COVID-19
Australian sponsor: Pacific Laboratory Products Pty Ltd
Date approved for supply: 10 Sep 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
Point-of-care test*
Antigen Test
Manufacturer: Quidel Corporation (United States Of America)
Name of test: Sofia® SARS Antigen FIA
Australian sponsor: Point Of Care Diagnostics Australia Pty Ltd
Date approved for supply: 26 Aug 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
Point-of-care test*
Nucleic Acid Test
Manufacturer: Roche Molecular Systems Inc (USA)
Name of test: cobas® SARS-CoV-2 & Influenza A/B
Australian sponsor: Roche Diagnostics Australia Pty Limited
Date approved for supply: 11 Dec 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
Point-of-care test*
Nucleic Acid Test
Manufacturer: Sansure Biotech Inc (China)
Name of test: Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Australian sponsor: Allsafe Medical Pty Ltd
Date approved for supply: 29 Jun 2020
Point-of-care test*
Antigen Test
Manufacturer: SD Biosensor Inc (Korea - Republic of)
Name of test: STANDARD™ Q COVID-19 Ag Test
Australian sponsor: Biocelect Pty Ltd
Date approved for supply: 30 Sep 2020
Point-of-care test*
Antigen Test
Manufacturer: SD Biosensor Inc (Korea - Republic of)
Name of test: SARS-CoV-2 Rapid Antigen Test
Australian sponsor: Roche Diagnostics Australia Pty Limited
Date approved for supply: 24 Dec 2020
Laboratory
Nucleic Acid Test
Manufacturer: Seegene Inc (Korea - Republic of)
Name of test: Allplex™ SARS-CoV-2 Assay
Australian sponsor: Integrated Sciences Pty Ltd
Date approved for supply: 17 Jun 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: Seegene Inc (Korea - Republic of)
Name of test: Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay
Australian sponsor: Integrated Sciences Pty Ltd
Date approved for supply: 18 Dec 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: Pocratis Medical Pty Ltd
Date approved for supply: 22 Sep 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: Shenzhen YHLO Biotech Co Ltd (China)
Name of test: iFlash-SARS-CoV-2 IgG
Australian sponsor: H3 Diagnostics Pty Ltd
Date approved for supply: 31 Jul 2020
Laboratory
Immunoassay
Manufacturer: Shenzhen YHLO Biotech Co Ltd (China)
Name of test: iFlash-SARS-CoV-2 IgM
Australian sponsor: H3 Diagnostics Pty Ltd
Date approved for supply: 31 Jul 2020
Laboratory
Immunoassay
Manufacturer: Siemens Healthcare Diagnostics Inc (United States Of America)
Name of test: Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)
Australian sponsor: Siemens Healthcare Pty Ltd
Date approved for supply: 30 Jul 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: Dimension Vista® SARS-CoV-2 Total antibody assay (COV2T)
Australian sponsor: Siemens Healthcare Pty Ltd
Date approved for supply: 30 Jul 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
Immunoassay
Manufacturer: Siemens Healthcare Diagnostics Inc (United States Of America)
Name of test: ADVIA Centaur® SARS-CoV-2 IgG assay
Australian sponsor: Siemens Healthcare Pty Ltd
Date approved for supply: 28 Jul 2020
Laboratory
Immunoassay
Manufacturer: Siemens Healthcare Diagnostics Inc (United States Of America)
Name of test: Atellica® IM SARS-CoV-2 IgG assay
Australian sponsor: Siemens Healthcare Pty Ltd
Date approved for supply: 28 Jul 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
Nucleic Acid Test
Manufacturer: Suzhou Sym-Bio Lifescience Co Ltd (China)
Name of test: PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel
Australian sponsor: PerkinElmer
Date approved for supply: 26 Nov 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
Laboratory/Point-of-care test*
Nucleic Acid Test
Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd (China)
Name of test: Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay)
Australian sponsor: Emergence Technology Pty Ltd
Date approved for supply: 2 Nov 2020
Laboratory
Nucleic Acid Test
Manufacturer: Vela Operations Singapore Pte Ltd (Singapore)
Name of test: ViroKey™ SARS-CoV-2 RT-PCR Test v2.0
Australian sponsor: Vela Diagnostics Australia Pty Ltd
Date approved for supply: 26 Aug 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
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
Point-of-care test*
Antigen Test
Manufacturer: VivaChek Biotech (Hangzhou) Co Ltd (China)
Name of test: VivaDiag™ SARS-CoV-2 Ag Rapid Test
Australian sponsor: Stonestar Wholesale Pty Ltd
Date approved for supply: 18 Nov 2020
Laboratory
Immunoassay
Manufacturer: Wallac Oy (Finland)
Name of test: GSP®/DELFIA® Anti-SARS-CoV-2 IgG kit
Australian sponsor: PerkinElmer
Date approved for supply: 2 Nov 2020
Laboratory
Nucleic Acid Test
Manufacturer: Wallac Oy (Finland)
Name of test: SARS-CoV-2 RT-qPCR Reagent Kit
Australian sponsor: PerkinElmer
Date approved for supply: 1 Sep 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: Xiamen Biotime Biotechnology Co Ltd (China)
Name of test: BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test
Australian sponsor: Cartex Hoya Pty Ltd
Date approved for supply: 9 Nov 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: 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: Zhongshan Chuangyi Biochemical Engineering Co Ltd (China)
Name of test: COVID-19 IgG/IgM Rapid Test Kit
Australian sponsor: LJCJ Pty Ltd
Date approved for supply: 7 Sep 2020
- Category:Medical devices/IVDs
- Tags:medical devices, COVID-19 tests
- URL:https://www.tga.gov.au/node/904122