TGA approved Flowflex Antigen Rapid Test for supply in Australia
The TGA has approved the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) for supply in Australia from 1 November 2021.
The TGA's performance requirements for COVID-19 rapid antigen self-tests are internationally aligned with technical specifications published by the World Health Organisation (WHO) and the European Commission. This includes a clinical sensitivity of at least 80% (for specimens collected within 7 days of symptom onset) and a clinical specificity of at least 98%.
The below table provides an indication of the performance of COVID-19 rapid antigen self-tests, including 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 who tested positive to COVID-19 using a rapid antigen self-test, compared to those who tested positive to COVID-19 using a more sensitive 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