FDA Alerts Health Care Providers and Clinical Laboratory Staff About SARS-CO-V2 Mutations


The agency warns SARS-CoV-2 mutations can trigger potential false negative results in molecular tests.

fda alert

The U.S. Food and Drug Administration (FDA) issued an alert today to both health care providers and clinical laboratory staff that SARS-CoV-2 mutations could cause false negative results in COVID-19 tests.

“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,” said FDA Commissioner Stephen M. Hahn, MD.

According to the FDA alert, 3 tests may be impacted by the mutations. These tests include the following: MesaBiotech Accula, TaqPath COVID-19 Combo Kit, and Linea COVID-19 Assay Kit.

“The impact does not appear to be significant,” the FDA wrote in their alert. “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. The recently identified B.1.1.7 variant has been associated with an increased risk of transmission, therefore early identification of this variant in patients may help reduce further spread of infection.”

Back in late December, it was reported the new COVID-19 variant, B.1.1.7, or otherwise known as VOC 202012/01, had been discovered in Western Europe. The mutation has since been reported in the US in a variety of states.

“On December 18, 2020, the South African government announced that it had also seen the emergence of a new strain in a scenario similar to that in the UK. The South African variant also has the N501Y mutation and several other mutations but emerged completely independently of the UK strain and is not related to it,” the CDC reported.

It is believed that the existing authorized vaccines from Moderna and the Pfizer and BioNtech vaccines could be efficacious against the new strain.

“At this time, we believe the data suggests that the currently authorized COVID-19 vaccines may still be effective against this strain,” Hahn said. “The FDA will continue to keep health care providers and the public informed of any new information as it becomes available.”

In a report today, in vitro data from Pfizer and the University of Texas Medical Branch indicate that the Pfizer and BioNtech vaccine, BNT162b2, is effective in preventing the mutated virus variants.

“The FDA will continue to monitor SARS-CoV-2 genetic viral variants to ensure authorized tests continue to provide accurate results for patients,” Hahn said.

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