The Australian Therapeutic Goods Administration (TGA) has introduced changes to permit the use of COVID-19 rapid antigen self-testing and point-of-care testing kits in Australia. Companies can now formally apply for TGA regulatory approval to supply rapid antigen COVID-19 self-tests for home use in Australia after 1 November 2021. The decision comes following extensive consultation with industry, and is a response to the growing use of rapid antigen COVID-19 testing kits globally and within certain domestic industries.
What is rapid antigen testing?
Rapid antigen COVID-19 testing has been used internationally and within some Australian industries to detect COVID-19 in people without any symptoms of the virus. Testing involves taking a nasal swab of a patient which is then placed in a chemical solution, with the results of the test generally obtained within 15 to 20 minutes.
Supply of rapid antigen test kits in Australia
For specific rapid antigen test kits to be made available and used in Australia, they require approval by the TGA and must be included on the Australian Register of Therapeutic Goods (ARTG). Rapid-antigen test kits include point-of-care tests (to be administered by a healthcare professional) and self-tests (for home use), discussed below in more detail. The TGA has indicated it will be continuing to work with manufacturers and suppliers of point-of-care tests and self-tests to ensure that users are provided with the appropriate level of support and instructions to properly use such testing kits.
The TGA has confirmed that health practitioners must conduct or oversee the performance of point-of-care tests. Sponsors of COVID-19 rapid antigen point-of-care tests included on the ARTG may only provide the testing kits to an accredited pathology laboratory, registered medical practitioners, paramedics, or organisations and residential care or aged care facilities and that employ or engage a health practitioner to conduct or oversee the performance of the test. These test kits cannot be supplied for the purpose of self-testing, and the sponsor must provide training to the persons who receive point-of-care tests to ensure the correct use of the kit. Sponsors will also have an obligation to maintain records to demonstrate compliance with these conditions.
Rapid antigen self-test kits are designed to enable consumers to self-test for the presence of COVID-19 infection. Unlike rapid antigen point-of-care tests, rapid antigen self-tests were prohibited and could not be supplied in Australia pursuant to the Excluded Purposes Specification 2020. Following the amendment of this instrument on 1 October 2021 to include self-tests for COVID-19, this position is due to change. The supply of self-tests will be legalised from 1 November 2021, and should be available in Australia thereafter (subject to each rapid-antigen self-test kit being approved by the TGA and included on the ARTG prior to supply).