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

20 October 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 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 - 107 of 107

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

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*

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

Antigen Test

Manufacturer: BIOHIT HealthCare (Hefei) Co Ltd (China)

Name of test: SARS-CoV-2 Antigen Rapid Test Kit

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*

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: 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 ELISA (IgA)

Australian sponsor: ESL Biosciences Australia 2012 Pty Ltd

Date approved for supply: 18 May 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

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 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

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: 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

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

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 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

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

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/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

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: Stonestar Wholesale Pty Ltd

Date approved for supply: 6 Apr 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

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: 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: 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: 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

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