01/11/2021: Lab Alert: FDA Issues Safety Letter about Genetic Variants of SARS-CoV-2 and False Negative Results with Molecular Tests

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Alert

On January 8, 2021, the U.S. Food and Drug Administration (FDA) issued a Letter to Clinical Laboratory Staff and Health Care Providers to clarify that genetic variants of SARS-CoV-2 may lead to false negative results when using molecular tests to detect SARS-CoV-2.

This letter includes important information about potential false negative results with molecular tests, including:

  • Details on the effect of genetic variants on test performance
  • Recommendations for clinical laboratory staff and health care providers
  • Actions the FDA has taken
  • Instructions for reporting problems with a test

For questions about this letter, email COVID19DX@fda.hhs.gov.

Online resources:

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

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

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

Centers for Disease Control and Prevention (CDC)