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.
Please share this message with your networks and invite them to opt in to LOCS to receive future updates.
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)