Resource: Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff
Source: U.S. Food and Drug Administration
Synopsis: The FDA is alerting clinical laboratory staff and health care providers that it 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 in the part of the virus’s genome assessed by that test. 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.
Comment: The United Kingdom COVID-19 variant is now ubiquitous in the United States; however, it does not appear to cause an increase in morbidity or mortality. It is responsive to monoclonal antibody therapy and antiviral therapy. It is important to realize that viral genetic mutation is common and expected.
