SARS-CoV-2 antigen tests may be less capable of detecting the Omicron variant, the U.S. FDA cautioned on Tuesday (Dec. 28).
The new warning is based on preliminary studies by the National Institutes of Health’s Rapid Acceleration of Diagnostics initiative using patient samples with live virus—analysis that “represents the best way to evaluate true test performance in the short-term,” according to FDA.
“Early data suggests that antigen tests do detect the Omicron variant but may have reduced sensitivity,” the FDA said