FDA Warns COVID-19 Tests Could Give False Negatives for New Strains

Authorized COVID-19 molecular tests could deliver false-negative results for patients infected with new coronavirus variants, including a highly infectious strain recently identified in the UK, the FDA has warned.

“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,” the agency said.

The FDA said it is working with test developers and conducting ongoing data analyses to evaluate all authorized tests, but said it believes there is only a low risk of mutations affecting overall testing accuracy.