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FDA Issues Alert to Clinical Laboratories About the Effects of New SARS-CoV-2 Variant on Testing

FDA maze of regulations

Impact of new SARS-CoV-2 variant on testing likely to be low, but does affect some tests, FDA warns

The US Food and Drug Administration (FDA) issued an alert to clinical laboratory staff and healthcare providers addressing the impact a new SARS-CoV-2 variant would have on existing testing methods. The new variant, B.1.1.7, was identified late last year in the United Kingdom and has gained more widespread attention due to the increased infectivity that mutations have caused.

The FDA warns “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,” but further notes, “the FDA believes the risk that these mutations will impact overall testing accuracy is low.”

With its warning, the FDA also addresses specific tests that the B.1.1.7 variant appears to impact. “Three currently authorized molecular tests, Mesa Biotech Accula, TaqPath COVID-19 Combo Kit, and Linea COVID-19 Assay Kit, may be impacted by genetic variants of SARS-CoV-2, but the impact does not appear to be significant,” the FDA notes. “Importantly, the detection pattern that appears with the TaqPath and Linea diagnostic tests when certain genetic variants are present may help with early identification of new variants in patients to reduce further spread of infection.”

Clinical laboratorians wanting to view the FDA alert in its entirety can do so here.

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