COVID-19 tests

Post‑market reviews

• The ability of COVID-19 tests to detect emerging genetic variants of SARS-CoV-2

  Information on the TGA post-market review of all point-of-care and laboratory tests included in the ARTG that are intended to identify patients with COVID-19 to ensure they can detect the emerging SARS-CoV-2 genetic variants and remain accurate.

• Post-market review of COVID-19 point-of-care tests

  Information on our post-market review of all approved COVID-19 tests and post-market evaluation of all approved serology-based COVID-19 point-of-care tests.

• Post-market review of antigen and rapid antigen tests

  Information on the TGA post-market review of all laboratory antigen and Rapid Antigen Tests (RATs) included in the ARTG. This includes point-of-care and self-tests.

• Post-market review of Nucleic Acid Tests

  Information on the TGA post-market review of all Nucleic Acid Tests (NATs) included in the ARTG.

• Q&As on COVID-19 rapid antigen self-tests

  Answers to frequently asked questions in relation to rapid antigen self-tests.

• COVID-19 serology point-of-care tests

  Learn about COVID‑19 serology and point‑of‑care tests, including how they work, how they are regulated in Australia, and important considerations for their use.

• Post-market evaluation of serology-based point of care tests

  In response to the COVID-19 pandemic, the TGA has expedited the approval (with conditions) of COVID-19 tests including tests intended for laboratory use and those intended for use by specified health professionals at the point of care.