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Home » Business, Policy & Funding » Regulatory News & FDA Approvals » FDA Issues Alert About Potential False Negative Test Results From SARS-CoV-2 Mutations

FDA Issues Alert About Potential False Negative Test Results From SARS-CoV-2 Mutations

Jan 08, 2021
|
staff reporter

NEW YORK – The US Food and Drug Administration issued a letter to clinical laboratory staff and healthcare providers Friday, alerting them to the potential for false negative SARS-CoV-2 test results due to mutations in the virus genome.

Through its ongoing analyses of viral sequences and proprietary Emergency Use Authorized test information, the agency has identified three molecular assays whose performance could be impacted by SARS-CoV-2 genetic variants.

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