The FDA notes that many of the emergency use authorization (EUA) tests currently being utilized are subject to false-negative results. The FDA emphasizes (here) that variants seen in the virus may have a significant impact on COVID-19 tests and this will likely occur with greater frequency, especially as some of the variants become predominant in the US.
The Agency specifically names four EUA authorized tests as problematic relative to potential false negatives from the variants and explains, “Clinical laboratory staff and healthcare providers should be aware that false negative results may occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the part of the virus’ genome assessed by that test.”
The article provides specifics on the four tests mentioned and describes potential impact and specific mutations that may cause the false negative results. In addition, the Agency provides a number of recommendations in the article to clinical laboratory staff and healthcare providers who use SARS-CoV-2 tests.
