Thursday 28 Mar 2024
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KUALA LUMPUR (Dec 29): Covid-19 antigen tests may be less capable of detecting the fast-spreading Omicron variant, the U.S. Food and Drug Administration (FDA) has flagged.

On Tuesday (Dec 28), the FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share new information regarding the impact of the SARS-CoV-2 omicron variant on antigen diagnostic tests.

The update includes preliminary study results of some antigen tests using patient samples containing live virus.

The FDA said early data suggest that antigen tests do detect the omicron variant but may have reduced sensitivity.

The FDA said it will continue to collaborate with the National Institutes of Health's (NIH) RADx program to further evaluate the performance of antigen tests using patient samples with live virus.

The authority said as of Dec 29, 419 tests and sample collection devices are authorised by the FDA under emergency use authorisations (EUAs).

It said these include 290 molecular tests and sample collection devices, 87 antibody and other immune response tests and 42 antigen tests.

There are 67 molecular authorisations and one antibody authorization that can be used with home-collected samples.

FDA said there is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, 12 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.

The FDA has authorised 23 antigen tests and nine molecular tests for serial screening programs.

The FDA has also authorised 747 revisions to EUA authorisations.

The FDA highlighted that the SARS-CoV-2 virus has mutated over time, resulting in genetic variation in the population of circulating viral strains over the course of the COVID-19 pandemic.

It said molecular, antigen, and serology tests are affected by viral mutations differently due to the inherent design differences of each test.

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