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Genetic Variants of SARS-CoV-2 May Lead to False Negative Results with Molecular Tests for Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers
Today, the U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that genetic variants of SARS-CoV-2 may lead to false negative results with molecular tests for SARS-CoV-2.
The Letter to Clinical Laboratory Staff and Health Care Providers includes important information about potential false negative results with molecular tests, including:
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Details on the effect of genetic variants on test performance.
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Recommendations for clinical laboratory staff and health care providers.
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Actions the FDA has taken.
- Instructions for reporting problems with a test.
Questions?
If you have questions about this Letter to Clinical Laboratory Staff and Health Care Providers, email COVID19DX@fda.hhs.gov
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