The U.S. Food and Drug Administration has cautioned healthcare providers and clinical laboratory staff that the agency is evaluating the potential impact of viral mutations, including the emerging variant from the United Kingdom called the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests.

It further stated 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 genome which is assessed by that particular test. The agency is taking additional steps to ensure that authorized tests continue to remain accurate by working with test developers and carrying out data analysis to assess all the authorized molecular tests. According to the FDA, the risk that these mutations will affect overall testing accuracy appears to be low… (FDA, January 8, 2021)