Rapid Antigen Test cancellations not due to the failure to detect the COVID-19 Omicron variant

The Therapeutic Goods Administration (TGA) is aware of several incorrect recent media reports asserting that some COVID-19 rapid antigen tests have been removed from the market by the TGA for failing to detect the Omicron COVID-19 variant.

To date, four RATs have been cancelled from the Australian Register of Therapeutic Goods (ARTG), but this was not because they have failed to detect the Omicron variant.

One product was cancelled by the TGA because the sponsor didn't provide sufficient data to demonstrate the sensitivity of the test for COVID-19 detection with the required guidelines. The remaining three were cancelled by the supplier, who can stop supplying RATs for a range of reasons and are not required to explain their rationale for doing so.

The use of RATs to monitor for SARS-CoV-2 infection is a vital measure in managing the COVID-19 pandemic. Although RATs are not as sensitive as Polymerase Chain Reaction (PCR) tests it is faster to perform these tests and receive a result. RATs are most accurate when used to test symptomatic patients. To be approved by the TGA, manufacturers are required to submit detailed data on product performance, which is assessed carefully by the TGA.

After our approval, manufacturers are required to continue providing up-to-date evidence to demonstrate that RAT performance requirements are met, including detection of variants of concern, such as Omicron.

The TGA continues to monitor RAT performance, with information regularly released on the TGA. The Doherty Institute is assisting by independently testing manufacturers' claims on test sensitivity. You can find out more about the TGA's testing and review of RATs on our post-market review of RATs page.

Contact for members of the media:

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