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FDA Warns of False Negative COVID Tests From Virus Mutations – Medscape

The FDA issued an alert about the potential of mutations, including the B.1.1.7 variant, affecting molecular COVID-19 tests. However, regulators said that risk…



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US regulators warned about the potential risk for false negative results with molecular tests for SARS-CoV-2 due to mutations such as a recently detected B.1.1.7 variant of the virus.
The US Food and Drug Administration (FDA) on Friday issued an alert to clinical laboratory staff and clinicians. The agency warned that false negative results can occur with any molecular test for the detection of SARS-CoV-2…

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