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CDC LOCS Lab Alert: FDA Issues Safety Letter about Genetic Variants of SARS-CoV-2 and False Negative Results with Molecular Tests

Publication Date: Jan 11, 2021

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:

  • COVID-19 Information for Laboratories
  • Frequently Asked Questions about COVID-19 for Laboratories
  • CDC COVID-19 website
  • Clinical Laboratory COVID-19 Response Calls
  • CDC Laboratory Outreach Communication System (LOCS)
  • Register for CDC Health Alert Network (HAN) notifications, including updates about COVID-19. Enter your email address, search for HAN, and sign up

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

This Lab Alert was originally published by the CDC Laboratory Outreach Communication System (LOCS) here.

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