On Jun. 11, 2021, Quidel announced today that it had received an amended Emergency Use Authorization (EUA) from the U.S. 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 features a sleek, miniaturized design that reads the same Sofia® SARS Antigen FIA tests as Sofia and Sofia 2 – with equal accuracy. 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 the latest product in Quidel’s best-selling Sofia instrumentation portfolio. Sofia Q utilizes Sofia® fluorescent technology to provide an accurate, objective, and automated result in 15 minutes. 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.

In addition to the Sofia Q, Quidel offers other rapid diagnostic instrumented systems, including Sofia 2, and Sofia. Quidel’s Sofia assays for rapid antigen COVID-19 diagnosis include Sofia® 2 SARS Antigen FIA and Sofia® 2 Flu + SARS Antigen FIA, currently under EUA by the FDA. Quidel offers other FDA-cleared and CLIA-waived tests including Influenza A and B, Respiratory Syncytial Virus (RSV), Group A Strep, and a 15-minute finger-stick whole blood test for Lyme Disease. In addition, Quidel also markets Sofia tests for Lyme Disease, Legionella and S. pneumoniae in Europe.