The TGA has approved the Alltest SARS-CoV-2 Antigen Rapid Test (Nasal Swab) for supply in Australia from 1st November 2021.
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
Source: https://www.tga.gov.au/covid-19-rapid-antigen-self-tests-are-approved-australia