FDA Warns New Coronavirus Mutations Can Cause False Negative Test Results

By Bill Galluccio

January 8, 2021

The Food and Drug Administration is warning healthcare providers and clinical laboratories that the mutated strains of COVID-19 could cause false-negative results.

The agency said that three FDA-approved tests, MesaBiotech Accula, TaqPath Covid-19 Combo Kit, and Linea Covid-19 Assay Kit, may be impacted by the new coronavirus strains but said the impact on testing accuracy is low. If a patient is exhibiting symptoms of COVID-19 and tests negative, the FDA advised them to undergo a different test to confirm the results.

"The FDA will continue to monitor SARS-CoV-2 genetic, viral variants to ensure authorized tests continue to provide accurate results for patients," FDA Commissioner Stephen M. Hahn, M.D. said in a statement. "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."

The FDA said that while the mutations could impact test results, the currently authorized vaccines appear to be effective against the new strains.

"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," Hahn added.

Photo: Getty Images

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