03/31/2021: Lab Advisory: FDA Publishes New Web Page on Impact of SARS-CoV-2 Viral Mutations on COVID-19 Molecular Tests

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Individuals Performing COVID-19 Testing

Level: Laboratory Advisory

On March 30, 2021, the U.S. Food and Drug Administration (FDA) posted a new Web page for clinical laboratory staff and health care providers about the impact of viral mutations on COVID-19 molecular tests. The FDA will update this page as significant new information becomes available.

The Web page includes:

  • Background and considerations for SARS-CoV-2 viral mutations
  • General information for clinical laboratory staff and health care providers
  • Specific molecular tests impacted by viral mutations and recommendations for those tests

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Online resources:

If you have any questions, please contact us at LOCS@cdc.gov.

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)