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

Information for sponsors, manufacturers and consumers on COVID-19 rapid antigen tests for self-testing.

Last updated

Update: Before collecting saliva for a COVID-19 self-test, don't eat, drink, smoke, brush your teeth, or chew gum for 10-30 minutes. Refer to the instructions provided with your test kit for the recommended timing.

General information

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

See COVID-19 rapid antigen self-tests approved in Australia.

Q&As on rapid antigen self-tests

Some questions and answers to help consumers, manufacturers, and sponsors understand these tests.

Q&As on combination rapid antigen self-tests

These questions and answers are on Combination rapid antigen self-tests (RATs). Combination RATs test a nasal swab, saliva, or oral fluid sample for multiple viruses that cause respiratory disease (e.g., COVID-19, Influenza A and Influenza B).

Information for consumers

Pharmacies, retail stores and online stores carry COVID-19 rapid antigen self-tests.

Refer to Obtaining approved COVID-19 rapid antigen tests for information on: 

  • obtaining these tests, 
  • how to spot unapproved tests, and 
  • the issues you may encounter when purchasing RATs.

Purchasing COVID-19 rapid antigen tests

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

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

For approved tests, see COVID-19 rapid antigen self-tests approved in Australia. The TGA website has PDF instructions for each approved self-test.

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. 

All rapid antigen self-tests should be in the original approved packaging. It's possible that the test won't work if all parts aren't included or the instructions aren't correct if test packs are divided and repackaged.

The test might not work if the packaging is damaged, or if it's exposed to too much light or heat. 

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.

Consumer fact sheet

This fact sheet explains what COVID-19 home use tests are and how they can be used at home.

Overseas travel

Here's what you need to know if you're going overseas and want to take your self-test:

It is important that you check what you can take to your destination. Some countries may not allow self-tests to be imported. It is important you check advice for the country you will be visiting.

Importing self-tests

The Personal Importation Scheme lets consumers import rapid antigen self-tests into Australia for personal use.

Under this scheme, you may need to show the self-tests are for you or your family.

Imports also have limits. Giving away or selling self-tests imported under this scheme is against the law.

See Department of Agriculture, Water and the Environment.

Information for manufacturers and sponsors

Conditions specific to COVID-19 rapid antigen self-tests

There are seven conditions for the supply of COVID-19 self-tests:

Customer support service

  1. The sponsor must provide 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 any safety related information, and
    2. operates between 9 am and 7 pm (AEST), or 9 am and 8 pm (AEDT), 5 days per week.
  2. The sponsor must ensure that 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 any safety related information, 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, and any safety related information on the sponsor's website.
  4. The sponsor must maintain records, and provide the records to the Secretary on request 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. The new version of the IFU can be sent to the TGA at the email address IVDs@tga.gov.au.

COVID-19 self-test and Combination RATs (rapid antigen tests) guidance

The following guidance assists sponsors and manufacturers to prepare their documentation for applications for COVID-19 rapid antigen self-tests and multiple respiratory targets such as influenza A, influenza B and COVID-19 in a single test format (Combination RATs).

Requirements for performance requirements, risk mitigation, usability studies and labelling requirements for COVID-19 rapid antigen self-tests.

COVID-19 rapid antigen self-test software and app requirements.

A guide to in vitro diagnostic medical devices (IVD) intended to be used for self-tests for seasonal influenza and combination tests (for both COVID-19 and Influenza).

Advertising COVID-19 rapid antigen self-tests

Information on how parties can legally advertise COVID-19 rapid antigen tests.

Reporting an adverse event or problem

Report an adverse event or problem with a home-use test online at Report a problem or side effects.

If you need help to report a problem, call 1800 809 361 (8:30 am to 5:00 pm, Monday to Friday) or email IRIS@health.gov.au.

 

 

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)

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