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

8 April 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 - 133 of 133

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 IgG Kit

Australian sponsor: Abbott Australasia Pty Ltd Diagnostic Division

Date approved for supply: 28 Jul 2020

Laboratory

Immunoassay

Manufacturer: Abbott Ireland Diagnostic Division (Ireland)

Name of test: SARS-CoV-2 IgG II Quant Kit

Australian sponsor: Abbott Australasia Pty Ltd Diagnostic Division

Date approved for supply: 11 Feb 2021

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

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 (Nasopharyngeal)

Australian sponsor: Abbott Rapid Diagnostics Pty Ltd

Date approved for supply: 30 Sep 2020

Point-of-care test*

Antigen Test

Manufacturer: Abbott Rapid Diagnostics Jena GmbH (Germany)

Name of test: Panbio™ COVID-19 Ag Rapid Test Device (Nasal)

Australian sponsor: Abbott Rapid Diagnostics Pty Ltd

Date approved for supply: 2 Mar 2021

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

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: 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

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: 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

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

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

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

Nucleic Acid Test

Manufacturer: BGI Europe A/S (Denmark)

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

Australian sponsor: BGI Health (AU) Company Pty Ltd

Date approved for supply: 7 Apr 2021

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

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

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

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/Flu/RSV

Australian sponsor: Cepheid Holdings Pty Ltd

Date approved for supply: 17 Feb 2021

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: Chaozhou Hybribio Biochemistry Ltd (China)

Name of test: COVID-19 Real-Time PCR kit (HBRT-COVID-19)

Australian sponsor: Rachael Flood

Date approved for supply: 12 Mar 2021

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

Point-of-care test*

Antigen Test

Manufacturer: CTK Biotech Inc (USA)

Name of test: OnSite® COVID-19 Ag Point of care test / Aria® COVID-19 Ag Rapid Test

Australian sponsor: MD Solutions Australasia Pty Ltd

Date approved for supply: 15 Jan 2021

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: Diesse Diagnostica Senese SPA (Italy)

Name of test: Chorus SARS-CoV-2 IgG

Australian sponsor: R-Biopharm Pty Ltd

Date approved for supply: 30 Mar 2021

Laboratory

Immunoassay

Manufacturer: Diesse Diagnostica Senese SPA (Italy)

Name of test: Chorus SARS-CoV-2 IgM

Australian sponsor: R-Biopharm Pty Ltd

Date approved for supply: 30 Mar 2021

Laboratory

Immunoassay

Manufacturer: Diesse Diagnostica Senese SPA (Italy)

Name of test: Enzywell SARS-CoV-2 IgA

Australian sponsor: R-Biopharm Pty Ltd

Date approved for supply: 30 Mar 2021

Laboratory

Immunoassay

Manufacturer: Diesse Diagnostica Senese SPA (Italy)

Name of test: Enzywell SARS-CoV-2 IgG

Australian sponsor: R-Biopharm Pty Ltd

Date approved for supply: 30 Mar 2021

Laboratory

Immunoassay

Manufacturer: Diesse Diagnostica Senese SPA (Italy)

Name of test: Enzywell SARS-CoV-2 IgM

Australian sponsor: R-Biopharm Pty Ltd

Date approved for supply: 30 Mar 2021

Laboratory

Immunoassay

Manufacturer: Diesse Diagnostica Senese SPA (Italy)

Name of test: Chorus SARS-CoV-2 IgA

Australian sponsor: R-Biopharm Pty Ltd

Date approved for supply: 30 Mar 2021

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

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*

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 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: 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 Total

Australian sponsor: Ortho-Clinical Diagnostics Australia Pty Ltd

Date approved for supply: 19 Jun 2020

Laboratory

Antigen Test

Manufacturer: Ortho-Clinical Diagnostics (United Kingdom)

Name of test: VITROS Immunodiagnostic Products SARS-CoV-2 Antigen

Australian sponsor: Ortho-Clinical Diagnostics Australia Pty Ltd

Date approved for supply: 9 Mar 2021

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

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

Laboratory

Immunoassay

Manufacturer: Roche Diagnostics GmbH (Germany)

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

Australian sponsor: Roche Diagnostics Australia Pty Limited

Date approved for supply: 23 Mar 2021

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: SARS-CoV-2 Rapid Antigen Test

Australian sponsor: Roche Diagnostics Australia Pty Limited

Date approved for supply: 24 Dec 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

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: 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: 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: Atellica® IM SARS-CoV-2 IgG (sCOVG) assay

Australian sponsor: Siemens Healthcare Pty Ltd

Date approved for supply: 29 Jan 2021

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 IgG (sCOVG) assay

Australian sponsor: Siemens Healthcare Pty Ltd

Date approved for supply: 29 Jan 2021

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: 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

Immunoassay

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

Name of test: Dimension EXL SARS-CoV-2 IgG Assay (CV2G)

Australian sponsor: Siemens Healthcare Pty Ltd

Date approved for supply: 19 Mar 2021

Laboratory

Immunoassay

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

Name of test: Dimension Vista® SARS-CoV-2 IgG Assay (CV2G)

Australian sponsor: Siemens Healthcare Pty Ltd

Date approved for supply: 19 Mar 2021

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: PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel

Australian sponsor: PerkinElmer

Date approved for supply: 26 Nov 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

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*

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

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

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: 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: Onsite Diagnostics Pty Ltd

Date approved for supply: 14 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