03/02/2021: Lab Advisory: FDA Issues New Guidance for Evaluating Impact of Viral Mutations on COVID-19 Tests

CDC's Laboratory Outreach Communication System (LOCS)

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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Thank you,

Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)

LOCS@cdc.gov

www.cdc.gov/csels/dls/locs

Page last reviewed: March 2, 2021