Follow your local state or territory health advice for information on rapid antigen tests:
About COVID-19 tests
COVID-19 is the disease caused by the SARS-CoV-2 coronavirus.
To detect if a person has COVID-19, there are 3 kinds of tests:
- Nucleic acid detection tests - to detect SARS-CoV-2 viral (Ribonucleic acid) RNA
- Rapid antigen tests (RATs) - to detect antigen viral proteins from the SARS-CoV-2 virus
- Serology tests - to detect IgM and/or IgG antibodies against SARS-CoV-2.
Approved tests
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PageView COVID-19 tests approved for inclusion in the Australian Register of Therapeutic Goods (ARTG).
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PageA list of approved COVID-19 tests included in the ARTG for supply in Australia.
More about COVID-19 tests
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PageInformation for sponsors, manufacturers and consumers on COVID-19 rapid antigen tests for self-testing
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PageFind information on the different types of COVID-19 tests and how we assess them and monitor their performance.
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PageAn overview of the requirements for importing COVID-19 rapid antigen tests into Australia
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PageInformation on the TGA post-market review of all point-of-care and laboratory tests included in the ARTG that are intended to identify patients with COVID-19 to ensure they can detect the emerging SARS-CoV-2 genetic variants and remain accurate.
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PageInformation on our post-market review of all approved COVID-19 tests and post-market evaluation of all approved serology-based COVID-19 point-of-care tests.
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PageInformation on the TGA post-market review of all laboratory antigen and Rapid Antigen Tests (RATs) included in the ARTG. This includes point-of-care and self-tests.
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PageInformation on the TGA post-market review of all Nucleic Acid Tests (NATs) included in the ARTG.
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PageAnswers to frequently asked questions in relation to rapid antigen self-tests.
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PageIn response to the COVID-19 pandemic, the TGA has expedited the approval (with conditions) of COVID-19 tests including tests intended for laboratory use and those intended for use by specified health professionals at the point of care.
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PageUpdate to information about applying for assessment of a COVID-19 test for inclusion in the ARTG.
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PageNew information about importing self-tests.
Guidance and resources
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GuidanceGuidance for sponsors of COVID-19 IVDs about their ongoing obligations
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GuidanceGuidance on the rules governing COVID-19 rapid antigen tests (RATs) advertising.
Contact us
If you're a sponsor or manufacturer and want more information about COVID-19 tests:
Email IVDs@tga.gov.au
Telephone 1800 141 144
For general COVID-19 enquiries contact the National Coronavirus Helpline on:
Telephone 1800 020 080 (available 24 hours a day, seven days a week)
News
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TGA confirms the performance of Australian approved Rapid Antigen Tests with COVID-19 Variants
Media releasesThe TGA has confirmed the performance of COVID-19 rapid antigen tests available on the Australian market with COVID-19 variants. -
Rapid Antigen Test cancellations not due to the failure to detect the COVID-19 Omicron variant
Media releasesThe TGA is aware of several incorrect recent media reports asserting that some COVID-19 rapid antigen tests have been removed from the market by the TGA for failing to detect the Omicron COVID-19 variant.
Guidance
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Meeting performance and safety requirements for COVID-19 in-vitro diagnostics (IVDs)
GuidanceGuidance for sponsors of COVID-19 IVDs about their ongoing obligations -
Advertising COVID-19 rapid antigen point-of-care tests and self-tests (home use)
GuidanceGuidance on the rules governing COVID-19 rapid antigen tests (RATs) advertising.
Legislation
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Therapeutic Goods (Medical Devices—Donor Screening) (COVID-19 Emergency) Exemption 2023
LegislationTo read the full text, visit the Federal Register of Legislation.