The U.S. Food and Drug Administration (FDA) updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share new information about the impact of the SARS-CoV-2 Omicron variant on antigen diagnostic tests.
The update includes preliminary study results of some antigen tests using patient samples containing live virus. The FDA said early data suggest that antigen tests detect the Omicron variant but may have reduced sensitivity.
The FDA said it is “collaborating with the National Institutes of Health's (NIH) RADx program to study the performance of antigen tests with patient samples that have the Omicron variant. RADx recently performed preliminary studies evaluating the performance of some antigen tests using patient samples containing live virus, which represents the best way to evaluate true test performance in the short-term.”
The FDA also said RADx “conducted initial laboratory tests using heat-inactivated samples for some of the currently available antigen tests, which were able to detect the Omicron variant, with similar performance when detecting other variants.” However, the agency added, “these laboratory data are not a replacement for clinical study evaluations using patient samples with live virus, which are ongoing. The FDA and RADx are continuing to further evaluate the performance of antigen tests using patient samples with live virus.”