Quidel secures EUA for rapid antigen test

2021 06 15 23 09 5472 Virus Antibody Antigen Epitope 400

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.

Page 1 of 16
Next Page