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.
Product types
Topics
Page history
Updates to state and territory testing information and contact us details
Updates to state and territory testing information and contact us details