Quidel Receives Amended FDA Emergency Use Authorization for New AI-Powered Sofia Q Rapid Antigen Test Device

Quidel Corporation (San Diego, CA, USA) has received an amended Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) allowing the company to market Sofia Q, its latest addition to the Sofia and Sofia 2 line of Fluorescent Immunoassay Analyzers (FIA).

Sofia Q utilizes Sofia fluorescent technology to provide an accurate, objective, and automated result in 15 minutes. Sofia Q features a sleek, miniaturized design that reads the same Sofia SARS Antigen FIA tests as Sofia and Sofia 2 - with equal accuracy. Quidel’s innovative design allows the Sofia Q device to be paired with the downloadable Sofia Q mobile application, which guides the user through the workflow and interprets the test result using a proprietary AI model. Sales of Sofia Q device will initially be limited to use with the Sofia SARS Antigen FIA in the CLIA and CLIA-waived professional segments.


“Sofia Q is our latest powerful diagnostic instrument designed to democratize access to the many benefits of our Sofia SARS rapid antigen tests and, ultimately, our full portfolio of Sofia tests for influenza, RSV, Strep and other conditions,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “We designed Sofia Q to be very affordably priced and conducive to widespread adoption across the ever-expanding global point-of-care and telemedicine marketplace. In the future, we believe Sofia Q will be ideal to serve consumers at home, as well as in schools and workplaces.”