You are here

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

12 January 2022

General information

COVID-19 self-tests (home-use tests) that are approved in Australia

All COVID-19 self-tests approved by the TGA are listed on the COVID-19 rapid antigen self-tests that are approved in Australia page, along with the instructions for how to use each test.

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

COVID-19 rapid antigen self-tests for home use are 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.

What to consider when purchasing COVID-19 rapid antigen tests

Consumers should be aware when purchasing COVID-19 rapid antigen self-tests (for home use) that only tests that are approved by the TGA should be sold by retailers and other outlets.

Tests that are intended for use by trained laboratory staff or health care professionals should not be repackaged and marketed as self-tests.

The Therapeutic Goods Administration (TGA) has published a list of COVID-19 rapid antigen self-tests that are approved in Australia. PDF instructions on how to use each approved self-test can be downloaded from the TGA website.

Each pack you purchase should include the test device, additional chemical regents, a copy of the instructions on how to use the tests, and information on how to access the online instructional video. The TGA has published a consumer fact sheet that explains what COVID-19 home use tests are, how they can be used at home, and what to do when you get your result.

All rapid antigen self-tests should be in the original approved packaging. If test packs are divided and repackaged, it is possible that the test will not work properly if all components are not included or the correct instructions are not provided. If the packaging around the test kit has been damaged, or the test is exposed to excessive light or heat, it may not work properly. Consumers are advised the best assurance that the COVID-19 self-test kits they purchase will work properly is to only purchase products in their original packaging.

If you have any concerns about how COVID-19 rapid antigen self-tests are being sold in retail outlets, you can report a perceived breach or questionable practice to the TGA.

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.

Travelling overseas?

If you are planning to travel overseas and want to know whether you can take your self-test with you, we advise that you review the following information:

It is really important that you check what you can take to your destination as some countries have different laws on what you can bring in and may not allow self-tests to be imported especially if they are not approved for supply in that country. It is important you check advice for the country you will be visiting.

Need more information?

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)

We have published information for sponsors, including how to submit an application for a COVID-19 self-test, and guidance for industry about COVID-19 tests.

Applicants will need to complete the supporting data checklist and submit it with their application along with supporting data for review:

The following ten (10) conditions will be imposed on the supply of COVID-19 self-tests included in the Register:

Customer support service

  1. The sponsor must provide a telephone helpline or on-line interactive support service that:
    1. provides immediate customer support on an individualised basis in relation to the correct use of the device and the interpretation of the test result; and
    2. operates between 9 am and 7 pm (AEST), or 9 am and 8 pm (AEDT), 7 days per week.
  2. The sponsor must ensure that telephone helpline and on-line operators providing customer support services mentioned in condition 1:
    1. have received training in the correct use and performance of the device, and the interpretation of the test result; and
    2. provide advice to users on how to contact relevant local state and territory health department support services including phone lines and websites.
  3. The sponsor must provide simple, clear and effective instructions, in video, pictorial or graphical form, in the correct use and performance of the device, and the interpretation of the test result, on the sponsor's website.
  4. The sponsor must maintain records that demonstrate that the device has been supplied in compliance with conditions 1 and 3, and that it has complied with condition 2, and provide the records to the Secretary on request.

Instructions for use

  1. The sponsor must publish on the sponsor's website, and also provide to the Therapeutic Goods Administration (TGA) for publication on the TGA website, any new version of the IFU released by the manufacturer, within 3 business days of the release.

Clinical studies

  1. Within 6 months of inclusion in the ARTG, the sponsor must provide a supplemental clinical study to the TGA, which shows the outcome of testing at least 30 clinical samples collected from individuals that are SARS-CoV-2 positive by RT-PCR for the delta variant.

Complaints

  1. The sponsor must submit all complaints related to the use and performance of the device including, but not limited to, adverse events and reports of false positive and false negative results to the TGA:
    1. for the period beginning on the day this condition is imposed, and ending at the conclusion of the next five (5) financial years; and
    2. through the Medical Device Incident Reporting and Investigation Scheme (IRIS); and
    3. as soon as the complaints are received by the sponsor.

Post market surveillance report

  1. The sponsor must provide a post market surveillance report, which includes the following information, to the TGA (at the email address postmarketdevices@health.gov.au) for each reporting period specified in condition 9:
    1. the numbers of tests sold both in Australia and overseas;
    2. any adverse events, including numbers of any reported false positive or false negative results, both in Australia and overseas;
    3. reported problems, issues or complaints associated with the use or interpretation of the device, both in Australia and overseas.
  2. For the purposes of condition 8, each of the following is a reporting period:
    1. the period beginning on the day when this condition is imposed, and ending on the day at the end of that month;
    2. each subsequent month up until 30 June 2022;
    3. each of the next three financial years.
  3. The report mentioned in condition 8, must be given:
    1. for a reporting period mentioned in paragraph (a) or (b) of condition 9—on or before the last day of the following month;
    2. for a reporting period mentioned in paragraph (c) of condition 9—before 1 October after that reporting period.

Guidance about COVID-19 self-tests for industry

We have published the following guidance to assist sponsors and manufacturers to prepare their documentation for applications for 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)