Food and Drug Administration (FDA) Alert for Health Care Providers, Clinical Laboratory Staff on SARS-CoV-2 Viral Mutation

Food and Drug Administration (FDA) Alert for Health Care Providers, Clinical Laboratory Staff on SARS-CoV-2 Viral Mutation

The FDA issued an alert to health care providers and clinical laboratory staff of the agency’s ongoing effort to monitor the potential molecular test impact resulting from SARS-CoV-2 mutations, including the variant that has emerged from the U.K. The FDA states that while the risk that these mutations will impact overall testing accuracy is low, “false negative results can occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the part of the virus’s genome assessed by that test.” The FDA is working with authorized test developers and conducting ongoing data analysis to ensure that health care providers and clinical staff are able to quickly and accurately diagnose patients infected with SARS-CoV-2, including those with emerging genetic variants.

If you have staff who are symptomatic, and test negative on a PCR test, they should not be working.

 

Questions?

Contact:

Laura Hofmann, MSN, RN – Director of Clinical and Nursing Facility Regulatory Services
c: 425-231-4804

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January 13, 2021