FDA warns UK coronavirus variant may result in false-negative tests

FDA warns UK coronavirus variant may result in false-negative tests


The Food and Drug Administration (FDA) on Friday issued an alert about the impact viral mutations of the coronavirus may have, including the potential to result in false negative tests. The variant, B.1.1.7 was first discovered in the U.K. several weeks ago, and has been confirmed in over 50 cases in the U.S. so far.

“The Food and Drug Administration is alerting clinical laboratory staff and health care providers that the FDA is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests, and that false negative results can occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs on the part of the virus’s genome assessed by that test,” the FDA said. “The SARS-CoV-2 virus can mutate over time, like all viruses, resulting in genetic variation in the population of circulating viral strains, as seen with the B.1.1.7 variant.”

The alert named

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