Tuesday, August 16, 2022

RATs recall not due to detection failure says TGA

The Therapeutic Goods Administration (TGA) has moved to clear up confusion over the removal of some COVID-19 rapid antigen tests (RATs) from shelves.

The cancellation of the products has led to public speculation that the test kits were failing to detect the COVID-19 virus, however the TGA says that’s not the case.

“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,” the TGA said in a statement today.

The test kits removed so far are CovClear by Medi-Stats, NowCheck by Life Bioscience, COVIFIND by Safe Interact and BD Veritor System for Rapid Detection test from Becton Dickinson.

It says one product was cancelled due to its sponsor not providing 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,” a TGA spokesperson said.

“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 said it was continuing to monitor RAT performance, with information regularly released on its website.

Australia’s Doherty Institute is assisting the Administration by independently testing manufacturers’ claims on test sensitivity.

You can find out more about the TGA’s testing and review of RATs on its post-market review of RATs page.

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