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COVID-19 test kits included on the ARTG for legal supply in Australia
The TGA has approved the following tests for inclusion on 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 has also been funded to undertake a post-market assessment of new COVID-19 rapid tests to inform their best use.
| Name of Test | Laboratory or POCT* | Type of Test | Australian Sponsor/Supplier** | Manufacturer | Date Approved for Supply |
|---|---|---|---|---|---|
|
2019-nCoV Ab Test (Colloidal Gold) |
POCT |
Lateral Flow IgG/IgM |
Aurora Future Education Group |
Innovita (Tangshan) Biological Technology Co Ltd (China) |
4 April 2020 |
|
2019-n-CoV IgG/IgM Rapid Test Cassette |
POCT |
Lateral Flow IgG/IgM |
AM Diagnostics - DC |
Hangzhou Alltest Biotech Co Ltd (China) |
23 March 2020 |
|
Allplex™ 2019-nCoV Assay |
Laboratory |
Nucleic Acid Test |
Integrated Sciences Pty Ltd |
Seegene Inc (Korea - Republic of) |
27 March 2020 |
|
AusDiagnostics respiratory virus panel (including SARS-CoV-2) test |
Laboratory |
Nucleic Acid Test |
AusDiagnostics Pty Ltd |
AusDiagnostics Pty Ltd (Australia) |
19 March 2020 |
|
Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test kit |
POCT |
Lateral Flow IgG/IgM |
MEDICISION PTY LTD |
Cellex Inc (United States Of America) |
31 March 2020 |
|
cobas® SARS-CoV-2 |
Laboratory |
Nucleic Acid Test |
Roche Diagnostics Australia Pty Limited |
Roche Molecular Systems Inc (USA) |
20 March 2020 |
|
COVID-19 IgG/IgM Rapid Test Cassette |
POCT |
Lateral Flow IgG/IgM |
Amandla China Pty Limited |
Zhejiang Orient Gene Biotech Co Ltd (China) |
1 April 2020 |
|
COVID-19 IgG/IgM Rapid Test Cassette |
POCT |
Lateral Flow IgG/IgM |
APAC Security Pty Ltd |
Hangzhou Clongene Biotech Co Ltd (China) |
26 March 2020 |
|
COVID-19 IgG/IgM Rapid Test Cassette |
POCT |
Lateral Flow IgG/IgM |
Ausliance Group Pty Ltd |
Hangzhou Clongene Biotech Co Ltd (China) |
4 April 2020 |
|
COVID-19 IgG/IgM Rapid Test Cassette |
POCT |
Lateral Flow IgG/IgM |
Medsupply Australia Pty Ltd |
HANGZHOU BIOTEST BIOTECH NO LTD (China) |
4 April 2020 |
|
Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit (Detection for 3 genes) |
Laboratory |
Nucleic Acid Test |
Icon International Pty Ltd t/a Icon Medipharm |
Shanghai ZJ Bio-Tech Co Ltd (China) |
22 March 2020 |
|
OnSite COVID-19 IgG/IgM Rapid Test |
POCT |
Lateral Flow IgG/IgM |
MD Solutions Australasia Pty Ltd |
CTK Biotech Inc (USA) |
19 March 2020 |
|
Panther Fusion® SARS-CoV-2 Assay (Panther Fusion® System) |
Laboratory |
Nucleic Acid Test |
Hologic (Australia & New Zealand) Pty Ltd |
Hologic Inc (USA) |
20 March 2020 |
|
SARS-CoV-2 Antibody Test (Lateral Flow Method) |
POCT |
Lateral Flow IgG/IgM |
Advangen International Pty Ltd |
Guangzhou Wondfo Biotech Co Ltd (China) |
25 March 2020 |
|
SARS-CoV-2 IgM/IgG Antibody Rapid Test |
POCT |
Lateral Flow IgG/IgM |
Envon Pty Ltd |
Qingdao Hightop Biotech Co Ltd (China) |
31 March 2020 |
|
TaqPath COVID-19 Combo Kit |
Laboratory |
Nucleic Acid Test |
Life Technologies Australia Pty Ltd |
Life Technologies Corporation (USA) |
24 March 2020 |
|
VIASURE SARS-CoV-2 Real Time PCR Detection Kit |
Laboratory |
Nucleic Acid Test |
Abacus dx Pty Ltd |
CerTest Biotec SL (Spain) |
31 March 2020 |
|
VIASURE SARS-CoV-2 S gene Real Time PCR Detection Kit |
Laboratory |
Nucleic Acid Test |
Becton Dickinson Pty Ltd |
CerTest Biotec SL (Spain) |
21 March 2020 |
|
VivaDiag™ COVID-19 IgM/IgG Rapid Test |
POCT |
Lateral Flow IgG/IgM |
Device Technologies Australia Pty Ltd |
VivaChek Biotech (Hangzhou) Co Ltd (China) |
26 March 2020 |
|
VivaDiag™ COVID-19 IgM/IgG Rapid Test |
POCT |
Lateral Flow IgG/IgM |
Endo X Pty Ltd |
VivaCheck Biotech (Hangzhou) Co Ltd (China) |
20 March 2020 |
|
Wantai SARS-CoV-2 Ab Rapid Test kit |
POCT |
Lateral Flow IgG/IgM |
Life Clinic Australia Pty Ltd |
Beijing Wantai Biologicalpharmacy Enterprise Co Ltd (China) |
27 March 2020 |
|
Xpert® Xpress SARS-CoV-2 |
Laboratory/POCT |
Nucleic Acid Test |
Cepheid Holdings Pty Ltd |
Cepheid (USA) |
22 March 2020 |
*POCT is a Point of Care Test.
**Only the Sponsor/Supplier listed in the table above, or a person acting on their behalf (i.e., the person has a distribution arrangement with the sponsor/supplier), can supply the device.