FDA grants emergency use authorisation for Sofia 2 SARS Antigen Test for COVID-19 detection.- Quidel Corp

Quidel Corporation announced that it has received Emergency Use Authorization (EUA) from the FDA to market its Sofia 2 SARS Antigen rapid point-of-care test to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid detection of SARS-CoV-2 in nasal or nasopharyngeal specimens from patients meeting the Centers for Disease Control and Prevention’s (CDC) criteria for suspected COVID-19 infection.

Sofia 2 is Quidel’s next-generation version of the Sofia instrumented system, utilizing the original Sofia fluorescent chemistry design while improving upon the graphical user interface and optics system to provide an accurate and automated result in 15 minutes.