Includes specific molecular tests impacted by viral mutations and recommendations for clinical laboratory staff and health care providers.

If your email program has trouble displaying this email, view as a webpage. SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests  Today, the U.S. Food and Drug Administration (FDA) posted a new web page for clinical laboratory staff and health care providers about the impact of viral mutations on COVID-19 molecular, antigen, and serology tests. The FDA will update this page as significant new information becomes available.   The web page includes:  Background on SARS-CoV-2 viral mutations.  General information for clinical laboratory staff and health care providers.  Specific molecular tests impacted by viral mutations and recommendations for those tests.  This web page builds on the letter the FDA issued January 8, 2021 alerting clinical laboratory staff and health care providers to the potential for false negative results due to the impact of viral mutations on molecular SARS-CoV-2 test.  The new web page also includes new information on the impact of viral mutations on Cepheid Xpert Xpress SARS-CoV-2, Xpert Xpress SARS-CoV-2 DoD, and Xpert Omni SARS-CoV-2 tests. Read More Questions? If you have questions, email COVID19DX@fda.hhs.gov.

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