COVID-19 tests

Find out how we test for COVID-19 in Australia.

Last updated

16 May 2024

On this page:

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

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

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View COVID-19 tests approved for inclusion in the Australian Register of Therapeutic Goods (ARTG).
COVID-19 rapid antigen self-tests that are approved in Australia

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A list of approved COVID-19 tests included in the ARTG for supply in Australia.

More about COVID-19 tests

How testing works for COVID-19

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Information on types of COVID-19 tests and how they work.
COVID-19 point-of-care tests

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Information about COVID-19 point-of-care tests.
COVID-19 rapid antigen self-tests (for home use)

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Information for sponsors, manufacturers and consumers on COVID-19 rapid antigen tests for self-testing
COVID-19 testing in Australia: information for health professionals

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Find information on the different types of COVID-19 tests and how we assess them and monitor their performance.
Importing COVID-19 rapid antigen tests (RATs)

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An overview of the requirements for importing COVID-19 rapid antigen tests into Australia
The ability of COVID-19 tests to detect emerging genetic variants of SARS-CoV-2

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Information 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.
Post-market review of COVID-19 point-of-care tests

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Information 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.
Post-market review of antigen and rapid antigen tests

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Information 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.
Post-market review of Nucleic Acid Tests

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Information on the TGA post-market review of all Nucleic Acid Tests (NATs) included in the ARTG.
Q&As on COVID-19 rapid antigen self-tests

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Answers to frequently asked questions in relation to rapid antigen self-tests.
COVID-19 serology point-of-care tests

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Information about COVID-19 serology point-of-care tests.
Post-market evaluation of serology-based point of care tests

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In 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.
Applying for TGA assessment of a COVID-19 test for inclusion in the ARTG

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Update to information about applying for assessment of a COVID-19 test for inclusion in the ARTG.
Instructions for sponsors who have interest in supplying a COVID-19 self-test

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New information about importing self-tests.

Guidance and resources

COVID-19 rapid antigen tests - information for manufacturers and sponsors

11 February 2022

Reference material

Information for manufacturers and sponsors on COVID-19 rapid antigen tests (RATs) regulatory requirements and processes.
Meeting performance and safety requirements for COVID-19 in-vitro diagnostics (IVDs)

30 September 2024

Guidance

Guidance for sponsors of COVID-19 IVDs about their ongoing obligations
Advertising COVID-19 rapid antigen point-of-care tests and self-tests (home use)

23 September 2024

Guidance

Information 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)

Latest news

TGA confirms the performance of Australian approved Rapid Antigen Tests with COVID-19 Variants

1 February 2023

Media releases

The TGA has confirmed the performance of COVID-19 rapid antigen tests available on the Australian market with COVID-19 variants.

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COVID-19 tests

About COVID-19 tests

Approved tests

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

COVID-19 rapid antigen self-tests that are approved in Australia

More about COVID-19 tests

How testing works for COVID-19

COVID-19 point-of-care tests

COVID-19 rapid antigen self-tests (for home use)

COVID-19 testing in Australia: information for health professionals

Importing COVID-19 rapid antigen tests (RATs)

The ability of COVID-19 tests to detect emerging genetic variants of SARS-CoV-2

Post-market review of COVID-19 point-of-care tests

Post-market review of antigen and rapid antigen tests

Post-market review of Nucleic Acid Tests

Q&As on COVID-19 rapid antigen self-tests

COVID-19 serology point-of-care tests

Post-market evaluation of serology-based point of care tests

Applying for TGA assessment of a COVID-19 test for inclusion in the ARTG

Instructions for sponsors who have interest in supplying a COVID-19 self-test

Guidance and resources

COVID-19 rapid antigen tests - information for manufacturers and sponsors

Meeting performance and safety requirements for COVID-19 in-vitro diagnostics (IVDs)

Advertising COVID-19 rapid antigen point-of-care tests and self-tests (home use)

Contact us

Latest news

TGA confirms the performance of Australian approved Rapid Antigen Tests with COVID-19 Variants

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COVID-19 tests

About COVID-19 tests

Approved tests

More about COVID-19 tests

Guidance and resources

Contact us

Latest news

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