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

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.