COVID-19 rapid antigen point-of-care and self-tests

The use of COVID-19 rapid antigen point-of-care tests is one part of Australia's strategy to combat COVID-19. The following information is provided so that rapid antigen tests are supplied for use by relevant health practitioners, and in appropriate circumstances. The Therapeutic Goods Administration (TGA) is progressing work that would allow the provision of self-tests (home-use tests) for COVID-19 in the future. Information and guidance are also provided below to allow sponsors to register their interest in supplying home-use tests.

How testing works for COVID-19

There are a number of ways for how we test for COVID-19 in Australia.

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

All COVID-19 test kits approved by the TGA for inclusion in the Australian Register of Therapeutic Goods (ARTG) are listed on the COVID-19 test kit page.

To find approved rapid antigen test kits, select 'Point-of-care test' under 'show only' and sort by 'Laboratory or Point of care test'.

All importers of COVID-19 test kits must apply for, and be granted, an import permit for all consignments of COVID-19 test kits that are imported into Australia, unless the importer can demonstrate that the goods are for personal use only or are entirely synthetic.

To apply for an import permit, please refer to BICON import permits(link is external).

COVID-19 rapid antigen self-tests

Registration of interest for sponsors of home-use tests

The supply of home tests for COVID-19 is currently prohibited however, the TGA is progressing work that would allow the provision of these tests in the future. Whilst a framework to support self-testing is being developed, potential sponsors are invited to register an expression of interest in supplying COVID-19 rapid antigen self-tests. Note: the TGA will not be accepting applications for inclusion at this stage.

Checklist for information that sponsors will be asked to provide in response to their registration of interest to supply a COVID-19 rapid antigen self-test.

Guidance about COVID-19 self-tests for industry

We have published the following guidance to assist sponsors and manufacturers to prepare their documentation for when applications are allowed to be submitted for COVID-19 rapid antigen self-tests.

COVID-19 rapid antigen self-tests - Guidelines on performance requirements and risk mitigation strategies

Information about the Therapeutic Goods Administration's (TGA) requirements concerning performance requirements (e.g. analytical and clinical sensitivity and specificity) risk mitigation, usability studies and labelling requirements for COVID-19 rapid antigen self-tests.

Software for use with COVID-19 rapid antigen self-tests - Guidelines on regulatory requirements

Information about the Therapeutic Goods Administration's (TGA) requirements for software and apps designed for use with COVID-19 rapid antigen self-tests.

Conditions specific to COVID-19 rapid antigen point-of-care tests

Show more information about The following four conditions are imposed on the supply of COVID-19 rapid antigen tests included in the Register:

Q&A - Conditions of supply for rapid antigen tests

We have developed a number of questions and answers to provide information about what tests are approved, and the supply and use of these tests.

Guidance for businesses wanting to implement testing in the workplace

We have published guidance on understanding the key considerations for establishing COVID-19 rapid antigen point-of-care testing in your workplace.

Guidance for advertising COVID-19 rapid antigen tests

We have published guidance which explains how parties can lawfully advertise COVID-19 rapid antigen tests for supply to businesses and organisations, and meet the requirements set out in the advertising permission.

Prohibitions and restrictions by State and Territory governments

Some states have prohibited or restricted use of SARS-CoV-2 Rapid Antigen Tests as an acute illness diagnostic tool for COVID-19. Please visit the Further information can be found on the Western Australian(link is external) and South Australian(link is external) * government websites for further information.

*Note that this does not apply to employees of SA Pathology or the SA Department of Health.

For more information please contact us at [email protected](link sends e-mail) or 1800 141 144.

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