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