COVID-19 rapid antigen self-tests that are approved in Australia

The TGA has approved the following COVID-19 self-tests (home use tests) for supply in Australia from 1 November 2021. Please refer to the instructions on how to use each test (that are provided in the table below) for further information on what sample types the test can be used with (e.g. nasal swab or saliva).

The TGA's performance requirements for COVID rapid antigen self-tests are internationally aligned with technical specifications published by the World Health Organisation (WHO) and the European Commission. This includes a minimum clinical sensitivity of at least 80% (for specimens collected within 7 days of symptom onset) and a minimum clinical specificity of at least 98%.

To provide an indication of the performance of COVID-19 rapid antigen self-tests, the table below includes information on the clinical sensitivity of each test. This is based on the studies performed by the manufacturer which show the positive percent agreement (PPA). PPA is the proportion of individuals that produced a positive test result using a COVID-19 rapid antigen self-test, in comparison with a positive result that was obtained using a more sensitive laboratory PCR test.

The inclusion of this information does not represent TGA endorsement of a particular test as all approved tests meet the performance requirements. The manufacturer’s sensitivity information is also included in the instructions provided with each test and can be viewed by clicking on the links in table below.

For each test a comment on the clinical sensitivity is assigned as follows:

• Acceptable sensitivity - clinical sensitivity greater than 80% PPA
• High sensitivity - clinical sensitivity greater than 90% PPA
• Very high sensitivity - clinical sensitivity greater than 95% PPA

COVID-19 self-tests (home use) approved by TGA

*Clicking on the name of the test will link to the instructions on how to use it. PDF Instructions on how to use the test are provided as a supplementary resource for the visually read tests listed below and do not meet disability access requirements.