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COVID-19 rapid antigen self-tests (for home use)
When will COVID-19 self-tests be available to use at home?
From 1 November 2021, Australians are able to test themselves for COVID-19 at home.
This is an important step in transitioning Australia's National COVID-19 Response now that vaccination rates are higher. 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.
WA and SA Governments currently have local arrangements in place that may prevent distribution of self-tests in those states.
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
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.
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.
Need more information?
- For more information visit the COVID-19 tests landing page.
- 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
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
- 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
- provide advice to users on how to access laboratory PCR testing to confirm a positive test result; 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 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.
- 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.
- 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
- as soon as the complaints are received by the sponsor.
Post market surveillance report
- The sponsor must provide a post market surveillance report, which includes the following information, to the TGA (at the email address firstname.lastname@example.org) for each reporting period specified in condition 9:
- the numbers of tests sold both in Australia and overseas;
- any adverse events, including numbers of any reported false positive or false negative results, both in Australia and overseas;
- reported problems, issues or complaints associated with the use or interpretation of the device, both in Australia and overseas.
- For the purposes of condition 8, each of the following is a reporting period:
- the period beginning on the day when this condition is imposed, and ending on the day at the end of that month;
- each subsequent month up until 30 June 2022;
- each of the next three financial years.
- The report mentioned in condition 8, must be given:
- for a reporting period mentioned in paragraph (a) or (b) of condition 9—on or before the last day of the following month;
- 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.
- 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.
If you require more information about the COVID-19 Rapid Antigen Self-test regulatory process, use the following contact details:
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)