Update: SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests

U.S. Food and Drug Administration sent this bulletin at 06/03/2021 11:39 AM EDT

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FDA - Center for Devices and Radiological Health

Update: SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests 

Today, the U.S. Food and Drug Administration (FDA) posted an update to the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share the latest information. 

The update added new information about a potential impact on the performance of the Mesa Biotech Inc. Accula SARS-CoV-2 Test due to a genetic mutation at positions 28877-28878 (AG to TC) in patient samples. 

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Questions?

If you have questions about this update, email COVID19DX@fda.hhs.gov