On January 8, 2021, the U.S. Food and Drug Administration (FDA) issued an alert warning that viral mutations of SARS-CoV-2 may produce false-negative results on current molecular tests.
“The U.S. 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 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. The FDA is taking additional actions to ensure authorized tests remain accurate by working with test developers and conducting ongoing data analysis to evaluate all currently authorized molecular tests. The FDA believes the risk that these mutations will impact overall testing accuracy is low.”
– U.S. Food and Drug Administration
While the impact does not yet appear to be significant, three currently authorized molecular tests have been identified as being vulnerable to inaccurate results produced by genetic variants of the virus. Those specific tests are as follows:
It is important to note that based on data, the FDA still believes that the currently authorized Covid-19 vaccines may still be effective against this strain. The FDA is committed to updating health care providers and the general public as soon as new information is available.