U.S. FDA Issues Virus Mutation Testing Alert

The U.S. Food and Drug Administration (FDA) published an alert for clinical laboratory staff and healthcare providers that the FDA monitors the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant.

The FDA stated on January 8, 2021, the impact ‘on authorized SARS-CoV-2 molecular tests and that false-negative results can occur with any molecular test for detecting SARS-CoV-2 if a mutation occurs in the part of the virus’s genome assessed by that test.’

The FDA said it’s taking additional actions to ensure that 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.’

The SARS-CoV-2 betacoronavirus 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 recently identified B.1.1.7 variant has been associated with an increased risk of transmission in the United Kingdom. Therefore early identification of this variant in patients may help reduce further spread of infection.

“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., in a press 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. 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 has been monitoring SARS-CoV-2 viral mutations, and their potential impact on testing, throughout the pandemic. The presence of SARS-CoV-2 genetic variants in a patient sample can potentially change a SARS-CoV-2 test’s performance.  

Tests that rely on the detection of multiple regions of the genome may be less impacted by genetic variation in the SARS-CoV-2 genome than tests that rely on the detection of only a single region.

Three currently authorized molecular tests, MesaBiotech Accula, TaqPath COVID-19 Combo Kit, and Linea COVID-19 Assay Kit, may be impacted by genetic variants SARS-CoV-2. Still, the impact does not appear to be significant, said the FDA.

Notably, the detection pattern that appears with the TaqPath and Linea diagnostic tests when specific genetic variants are present may help with the early identification of new variants in patients to reduce the further spread of infection.

The FDA has reminded clinical laboratory staff and healthcare providers about the risk of false-negative results with all laboratory tests, including molecular tests. Laboratories should expect some false results to occur even when very accurate SARS-CoV-2 tests are used. 

‘Today’s announcement also provides important information and recommendations for clinical laboratory staff and healthcare providers who use molecular tests for the detection of SARS-CoV-2,’ said the FDA.

Furthermore, the FDA encourages stakeholders to report any adverse events or suspected adverse events experienced with molecular tests to detect SARS-CoV-2. Voluntary reports can be submitted through MedWatch, the FDA Safety Information, and Adverse Event Reporting program. 

Healthcare personnel and clinical laboratory staff employed by facilities performing COVID-19 testing should follow authorized laboratories' reporting requirements as specified in the test’s Emergency Use Authorization. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

The FDA is an agency within the U.S. Department of Health and Human Services, protects public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use and medical devices.

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