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COVID-19 rapid antigen self-tests
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When will COVID-19 self-tests be available to use at home?
On 1 October 2021 the Therapeutic Goods Administration (TGA) made a new regulation (Specification) that allows companies to formally apply for TGA regulatory approval to legally supply their self-tests for use at home in Australia after 1 November 2021.
This is an important step in supporting the National Plan to transition Australia's National COVID-19 Response and aligns with the timeframe where it is expected that approximately 70 % of Australians will be double vaccinated.
Individual tests will require TGA approval and inclusion in the Australian Register of Therapeutic Goods (ARTG) as for all other testing kits.
To ensure the reliable use of these tests at home it is important they are easy to use and interpret. Any consumer who has a positive rapid antigen test result should immediately have a confirmatory PCR test at a COVID-19 testing centre.
General information
COVID-19 self-tests (home-use tests) that are approved in Australia
All COVID-19 self-tests approved by the TGA is provided along with the instructions for how to use each test are listed on the COVID-19 self-test page.
Q&As on rapid antigen self-tests
We have developed a number of questions and answers to provide consumers, manufacturers and sponsors information about the supply and use of these tests.
Information for consumers
Consumers are advised to only purchase and use self-tests (home-use tests) that have been approved by TGA. These tests will be widely available through pharmacies, local retail outlets and on-line. Consumers can refer to the Fact sheet on COVID-19 self-testing for further information on the correct use of these tests and the need for appropriate follow-up actions including further PCR testing, if the results are positive, or infection with COVID-19 is suspected.
Consumer fact sheet
This fact sheet explains what COVID-19 home use tests (also known as COVID-19 rapid antigen self-tests) are, how they can be used at home and what to do when you get a result.
Need more information?
- For state and territory COVID information visit the relevant local state and territory health departments.
- For other relevant information about COVID-19 visit the Commonwealth Department of Health website.
How to report a problem or issue with a self-test for home-use
Problems or issues with home use tests can be reported directly to the supplier/sponsor of the test or to the place where you purchased the test.
You can also report problems to the Therapeutic Goods Administration online at Report a problem or side effect.
If you require assistance to report a medical device problem, call 1800 809 361 (08:30 am to 5:00 pm, Monday to Friday) or email IRIS@health.gov.au.
Information for manufacturers and sponsors
How to submit an application to supply a COVID-19 self-test (home-use test)
The TGA is now accepting applications for inclusion in the Australian Register of Therapeutic Goods (ARTG) of self-tests for COVID-19 for supply in Australia from 1 November 2021. While the framework was being developed potential sponsors were invited to register an expression of interest in supplying COVID-19 rapid antigen self-tests and complete a supporting data checklist. The registration of interest process is now closed as sponsors are now able to submit applications.
The TGA is now reviewing applications and will take into consideration the information already provided by suppliers who responded to the registration of interest process.
We have published information for sponsors who have an interest in supplying a COVID-19 self-test, including how to submit an application for a COVID-19 self-test, and guidance for industry about COVID-19 tests.
Conditions specific to COVID-19 rapid antigen self-tests
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 - Guidance 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 - Guidance 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.
Advertising COVID-19 rapid antigen self-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.
How to report an adverse event or problem with a home-use test
An adverse event or problem with a home-use test can be reported online at Report a problem or side effect.
If you require assistance to report a problem, call 1800 809 361 (08:30 am to 5:00 pm, Monday to Friday) or email IRIS@health.gov.au.
Contact us
If you require more information about the COVID-19 Rapid Antigen Self-test regulatory process, use the following contact details:
Email: COVIDtests@tga.gov.au
Telephone: 1800 141 144
If you have a general enquiry about COVID-19 contact the National Coronavirus Helpline on:
Telephone: 1800 020 080 (available 24 hours a day, seven days a week)