FDA issues alert regarding SARS-CoV-2 viral mutation to health care providers and clinical laboratory staff

FDA issues alert regarding SARS-CoV-2 viral mutation to health care providers and clinical laboratory staff

cbaker_admin
Tue, 01/12/2021 – 02:30

FDA issued a warning to clinical laboratory staff and health care providers that 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. According to FDA, the risk these mutations will affect overall testing accuracy is low, but the agency is taking additional steps to ensure authorized tests continue to be accurate by working with test developers and conducting ongoing data analysis to evaluate all currently authorized molecular tests. “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,” said FDA Commissioner Stephen Hahn, MD. He added, however, that “at this time, we believe the data suggests that the currently authorized COVID-19 vaccines may still be effective against this strain.” Three currently authorized molecular tests—MesaBiotech Accula, TaqPath COVID-19 Combo Kit, and Linea COVID-19 Assay Kit—could be affected by genetic variants of SARS-CoV-2, “but the impact does not appear to be significant,” FDA said. Furthermore, it noted the detection pattern that appears with the TaqPath and Linea diagnostic tests when particular 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,” FDA said.