TGA updated advice on RATs nearing expiry and RATs efficacy on current strains
The TGA has provided advice on the use of expired RATs and the efficacy of RATs on current COVID variants.
The Therapeutic Goods Administration (TGA) recommends against the use of expired rapid antigen tests (RATs).
However, many RAT manufacturers have extended the approved shelf-life of their RATs based on more recent stability testing. These extensions are included on the TGA’s website that provides information on the approved shelf-life of RATs.
Sponsors of RATs are required to monitor the ongoing performance and safety of their devices.
The TGA has received evidence from manufacturers of COVID-19 RATS demonstrating performance against variants up to omicron sub-variant BA.5. This evidence is published as part of the COVID-19 RAT post-market review.
Evidence provided by manufacturers has demonstrated ongoing performance of the devices against new Variants of Concern (VOC) as they have appeared. The TGA continues to focus on VOC. As of 15 March 2023, the WHO currently has no listed VOCs.
The TGA continues to monitor variants circulating in Australia and will take appropriate action on supply if there is an indication that new variants are impacting the performance of the tests.
