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Quidel’s Sofia 2 SARS Antigen FIA Becomes First COVID-19 Antigen Test to Secure FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 11 May 2020

Image: Quidel Corporation’s Sofia 2 SARS Antigen FIA (Photo courtesy of Quidel Corporation)

Quidel Corporation’s (San Diego, CA, USA) Sofia 2 SARS Antigen FIA has become the first COVID-19 antigen test to be granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA).

The Sofia 2 SARS Antigen FIA is a 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. The assay is currently available for sale in the United States under EUA, and Quidel is now shipping the product to its customer
Sofia 2, Quidel’s next-generation version of its Sofia instrumented system, utilizes the original Sofia fluorescent chemistry design while improving upon the graphical user interface and optics system to provide an accurate, objective and automated result in 15 minutes. The next-generation Sofia 2 system also comes connected to Virena, Quidel’s data management system, which provides aggregated, de-identified testing data in near real-time.

The Sofia 2 instrument also offers two distinct workflows: depending upon the user’s choice, the Sofia 2 SARS Antigen FIA cartridge is placed inside Sofia 2 for automatically timed development (WALK AWAY Mode); or test cartridges can be placed on the counter or bench top for a manually timed development and then placed into Sofia 2 to be scanned (READ NOW Mode), allowing the user to markedly increase testing throughput per hour.

“In the fight against COVID-19, our employees are truly making a difference, and I am tremendously proud of our organization’s ability to quickly develop and mobilize an accurate rapid antigen test,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “The EUA for our Sofia 2 SARS Antigen FIA allows us to arm our healthcare workers and first responders with a frontline solution for COVID-19 diagnosis, accelerating the time to diagnosis and potential treatment of COVID-19 for the patient.”

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