Quidel has obtained an amended Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its Sofia Q, expanding its line of Fluorescent Immunoassay Analysers (FIA).
Sofia Q device is claimed to feature a compact design that reads the same Sofia SARS Antigen FIA tests as Sofia and Sofia 2 with similar accuracy.
The company intends to restrict the sales of its Sofia Q device initially to the CLIA and CLIA-waived professional facilities, for use with the Sofia SARS Antigen FIA.
Quidel Corporation president and chief executive officer Douglas Bryant said: “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.
“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.”
Quidel leveraged Sofia fluorescent technology for its Sofia Q device
Quidel manufactures diagnostic healthcare products including rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems.
Sofia Q is the latest addition to its Sofia portfolio of products, and leverages Sofia fluorescent technology to offer an accurate, objective, and automated result in 15 minutes.
The device is designed for pairing with the Sofia Q mobile application, which guides the user through the workflow and interprets the test result using a proprietary AI model.
In addition to Sofia Q, the company also provides other rapid diagnostic systems, including Sofia 2, and Sofia assays for rapid antigen Covid-19 diagnosis.
The company’s Sofia 2 SARS Antigen FIA and Sofia 2 Flu + SARS Antigen FIA are currently being used under the FDA EUA.
Furthermore, Quidel offers other FDA approved and CLIA-waived tests for Influenza A and B, Respiratory Syncytial Virus (RSV), Group A Strep, and for Lyme Disease.
