TGA reviews effectiveness of rapid antigen tests for new variants

By Jackson Graham

Tuesday January 11, 2022

A number of Australia’s leading health organisations have banded together in support of the TGA to condemn reports of threats aimed at staff. 
The TGA is reviewing rapid antigen tests for their ability to pick up emerging variants of concern (AAP Image/Lukas Coch)

Australia’s medical regulator is reviewing all registered rapid antigen tests to determine how COVID-19 variants impact results and whether the tests can detect emerging variants. 

The “post-market review” includes laboratory testing of rapid antigen tests to validate their performance in detecting variants including Delta and Omicron, a Therapeutic Goods Administration statement says. 

The regulator says in order for the tests to meet sensitivity requirements they must comply with WHO guidelines and each manufacturer is expected to undertake an analysis of its tests as a new variant of concern emerges.

The TGA review, which will be done by the Doherty Institute, is an additional measure to verify each manufacturer’s claims,

“Variants of the virus due to mutations in the protein target of the genome may alter the structure of a viral protein,” the TGA says. 

“As a result, test kits may no longer be able to detect the virus, leading to false negative results.” 

The Doherty Institute is due to commence the testing this Saturday, January 15.

The TGA has listed 24 kits where manufacturers have provided evidence to support their effectiveness in detecting variants. 

None specifically refer to the Omicron variant while most list to the Delta variant. One device, the CovClear COVID-19 Antigen Test has had its registration suspended due to safety and performance concerns. 

The regulator says in order for the tests to meet sensitivity requirements they must comply with WHO guidelines. Each manufacturer is expected to undertake an analysis of its tests as a new variant of concern emerges.

“Through the post-market review processes, if safety and performance concerns, or non-compliance issues are identified, the TGA may undertake further regulatory action,” its statement says. “This may include suspending or removing the devices from supply in Australia.” 

The post market review comes as states including Victoria and Queensland have set up online reporting for people to upload their result after testing positive using a rapid antigen test.

But supply of rapid antigen tests has constrained across all states and territories, with major supermarkets and chemists continuing to list they were out of stock on Tuesday.

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