January 8, 2021 — The U.S. Food and Drug Administration (FDA) is alerting healthcare providers that it is monitoring the potential impact of COVID (SARS-CoV-2) viral mutations, including the emerging variant from the United Kingdom and its potential to produce false negative results on FDA authorized SARS-CoV-2 molecular tests.
Despite the alert issued today, the FDA believes the risk that these mutations will impact overall testing accuracy is low.