03/02/2021: Lab Advisory: FDA Issues New Guidance for Evaluating Impact of Viral Mutations on COVID-19 Tests
Audience: Individuals Performing COVID-19 Testing
Level: Laboratory Advisory
The U.S. Food and Drug Administration (FDA) recently issued new guidance for test developers. “Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests” provides information on evaluating the potential impact of viral genetic mutations, which may be the basis of viral variants, on COVID-19 tests.
FDA has already issued a safety letter to caution that a patient specimen containing a viral variant of SARS-CoV-2 can potentially change the performance of some emergency use authorized diagnostic tests.
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