FDA Reviewing Effects of COVID-19 Variants on Diagnostic Tests


The FDA has identified 3 molecular tests that may be impacted by an emerging SARS-CoV-2 variant.

Molecular test

FDA officials have released an alert for clinical laboratory staff and health care providers regarding information on viral mutations of coronavirus disease 2019 (COVID-19).

Amid reports of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant from the United Kingdom, known as B117, the FDA announced that it is acting to ensure the accuracy of molecular diagnostic tests authorized by the agency.

Related: IDSA Releases Revised Guidelines for COVID-19 Diagnostic Testing

As of press time, the FDA has identified 3 authorized molecular tests that may be negatively affected by genetic variants: MesaBiotech Accula, TaqPath COVID-19 Combo Kit, and Linea COVID-19 Assay Kit. However, “the impact does not appear to be significant,” the news release stated.

“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, MD. “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,” Hahn continued.

The agency also reminded health care professionals that false negatives can occur in all forms of SARS-CoV-2 molecular tests if a portion of the virus’ genome experiences a mutation. While the FDA has not yet identified data suggesting that SARS-CoV-2 variants are degrading the efficacy of diagnostic tests, it is a possibility, the agency noted.

“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.”

The FDA also encouraged stakeholders to report any adverse events to molecular tests to MedWatch, the FDA Safety Information and Adverse Event Reporting program.


  1. FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff. News release. FDA; January 8, 2020. Accessed January 8, 2020. https://www.fda.gov/news-events/press-announcements/fda-issues-alert-regarding-sars-cov-2-viral-mutation-health-care-providers-and-clinical-laboratory.

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