First combination COVID-19 and influenza self-tests approved for Australia

The Therapeutic Goods Administration (TGA) has approved the first two nasal combination self-tests (for use at home) that detect both COVID-19 and influenza viral infections in humans:

• TouchBio SARS-CoV-2 & FLU A/B Antigen Combo Test (Nasal)
• Fanttest COVID-19 / Influenza A&B Antigen Test Kit.

Combination self-tests are like other COVID-19 rapid antigen tests (RATs) but feature an additional line on the test cassette that indicates the presence of influenza A and B. For many consumers, distinguishing between COVID-19 and influenza is important in managing their infections.

The TGA anticipates that the suppliers of these combination tests will make them available for consumers to buy at pharmacies, supermarkets or online. These tests must be supplied with the TGA-approved Instructions for Use and also include telephone support details for users and links to online instructional videos. These self-tests are for adults, noting that children require adult supervision when using the tests.

In approving these tests, the TGA considered clinical and analytical data that demonstrated they meet the minimum performance criteria for both COVID-19 and influenza self-tests.

The approvals are subject to conditions that require the sponsors of the tests to provide the TGA with on-going quality and performance information. This includes reporting of any problems with the use of the tests such as users who experience false positives or false negatives, and evidence to demonstrate that the tests continue to perform with any emerging COVID-19 variants.

These new combination COVID-19 and influenza tests are also subject to independent laboratory verification testing by the Peter Doherty Institute for Infection and Immunity and the National Reference Serology Laboratory.

For additional information on combination rapid antigen self-tests including the Instructions for Use go to; 

• Q&As on combination rapid antigen self-tests
• COVID-19 rapid antigen self-tests that are approved in Australia.

Contact for members of the media:

• Email: news@health.gov.au
• Phone: 02 6289 7400