Quidel has garnered an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Sofia Q rapid antigen test, the latest addition to the company's line of fluorescent immunoassay analyzers (FIA).
Sofia Q features a miniaturized design that can provide the same level of accuracy on Sofia SARS antigen FIA tests as Quidel's Sofia and Sofia 2 offerings, according to the vendor. The device can be paired with the Sofia Q mobile app to guide users through the workflow and interpret test results using an artificial intelligence (AI) algorithm. Results from Sofia Q are available in 15 minutes, Quidel said.
The firm will initially make Sofia Q available only for the professional and point-of-care market segments but plans in the future to also offer the system for telemedicine and home use.