Update: Do not 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) before collecting saliva for a COVID-19 self-test as it may produce an incorrect result.
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.
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
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 purchasing approved RATs / self-tests for further information on obtaining these tests, how to spot unapproved tests, and the issues you may encounter when purchasing RATs.
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:
- Travelling with medicines and medical devices
- Leaving Australia - taking medicines and medical devices with you
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.
Importing self-tests
Consumers can legally import rapid antigen self-tests into Australia for their own personal use under the Personal Importation Scheme.
If you import self-tests under this scheme, you may be required to show the self-tests are for your own personal use or the use of your immediate family. There are also limits on what can be imported. Giving away or selling self-tests imported under this scheme is against the law.
Further information is available on the Department of Agriculture, Water and the Environment website.
Need more information?
- For more information about COVID-19 point-of-care tests visit COVID-19 point-of-care tests.
- 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)
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:
Conditions specific to COVID-19 rapid antigen self-tests
The following ten (10) conditions will be imposed on the supply of COVID-19 self-tests included in the Register:
Customer support service
- The sponsor must provide a telephone helpline or on-line interactive support service that:
- 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
- operates between 9 am and 7 pm (AEST), or 9 am and 8 pm (AEDT), 7 days per week.
- The sponsor must ensure that telephone helpline and on-line operators providing customer support services mentioned in condition 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
- provide advice to users on how to contact relevant local state and territory health department support services including phone lines and websites.
- 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.
- 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
- 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.
Complaints
- 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:
- for the period beginning on the day this condition is imposed, and ending at the conclusion of the next five (5) financial years; and
- through the Medical Device Incident Reporting and Investigation Scheme (IRIS); and
- sponsorin accordance with the timeframes specified for providing information about adverse events etc, as specified in Regulation 5.7 of the Therapeutics Goods (Medical Devices) Regulations 2002.
Post market surveillance report
- The sponsor must provide a post market surveillance report, which includes the following information:
- the numbers of tests supplied in Australia and overseas;
- any adverse events, reported problems, issues or complaints associated with the use or interpretation of the device, including numbers of any reported false positive or false negative results, for tests supplied in Australia and overseas;
- c. for each type of problem, issue or complaint, provide the manufacturer’s analysis of the issue and its risks, as well as any emerging trends. Provide a list of decisions and actions taken, or that are in progress in relation to investigations and risk minimisation of the issue to users and the general public, including well-reasoned rationale if no action is being taken.
- The report is to be sent to the TGA (at the email address postmarketdevices@health.gov.au) for
- the period beginning on the day when this condition is imposed, and ending on the day at the end of that month for Australian data;
- each subsequent month up until 30 June 2023;
- on or before the last day of the following month;
- Overseas data is only required 6 monthly from the period beginning on the day when this condition is imposed.
- The sponsor must provide a post market surveillance report, which includes the following information:
- any adverse events, reported problems, issues or complaints associated with the use or interpretation of the device, including numbers of any reported false positive or false negative results, both in Australia and overseas.
- for each type of problem, issue, or complaint reported in Australia, provide the manufacturer's analysis of the issue and its risks, as well as any emerging trends. Provide a list of decisions and actions taken, or that are in progress in relation to investigations and risk minimisation of the issue to users and the general public, including well-reasoned rationale if no action is being taken.
- The report is to be sent to the TGA (at the email address postmarketdevices@health.gov.au) for:
- the period beginning on the day when this condition is imposed, and ending on the next 30 June.
- each of the next three financial years.
- before 1 October after that reporting period
Guidance about COVID-19 self-test and Combination RATs (rapid antigen 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 and multiple respiratory targets such as influenza A, influenza B and COVID-19 in a single test format (Combination RATs).
- 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.
- Seasonal Influenza Rapid Antigen and Combination tests
Information about the Therapeutic Goods Administration's (TGA) expectations concerning clinical performance requirements (i.e. clinical sensitivity and specificity) and risk mitigation for in vitro diagnostic medical devices (IVDs) intended to be used as self-tests for seasonal influenza and combination tests (for both COVID-19 and Influenza).
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)