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 MesaBioTech Accula, TaqPath COVID-19 Combo Kit and Linea COVID-19 Assay Kit as the authorized molecular test kits that may be impacted by the variant, but noted that the impact “does not appear to be significant.”

It also noted that the detection pattern used with the TaqPath and Linea tests when certain genetic variants are present may even help detect new variants in patients, potentially helping to reduce spread.

The regulatory agency said that while it believes the overall risk the variant poses to test accuracy is low, it will continue working with test developers to conduct ongoing analysis and research to evaluate test efficacy against the variant.

“The FDA will continue to monitor SARS-CoV-2 genetic viral variants to ensure authorized tests continue to provide accurate results for patients,” said FDA Commissioner Stephen M. Hahn, M.D. “While these efforts continue, we are working with authorized test developers and reviewing incoming data to ensure that health care providers and clinical staff can quickly and accurately diagnose patients infected with SARS-CoV-2, including those with emerging genetic variants. At this time, we believe the data suggests that the currently authorized COVID-19 vaccines may still be effective against this strain. The FDA will continue to keep health care providers and the public informed of any new information as it becomes available.

While not believed to be more fatal or severe than the current widespread COVID-19 strain, the U.K. variant is believed to be more transmissible, with the potential to eventually be more widespread.

Research is ongoing as to how the recently-approved vaccines may combat the variant, but early studies conducted by Pfizer appear to show that the jab will remain effective. Previously, Pfizer had touted the “flexibility” of mRNA technology should the need for tweaks to the vaccine be necessary.


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