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