QuidelOrtho Earns De Novo Nod for Sofia 2 SARS Antigen+ FIA

QuidelOrtho has been granted de novo authorization from the U.S. Food and Drug Administration (FDA) for its Sofia 2 SARS Antigen+ FIA. According to the company, it’s the first rapid antigen test that detects COVID-19 to earn FDA clearance. The test is prescription use only and can be used in point-of-care settings.
 
The Sofia 2 SARS Antigen+ FIA is a lateral flow immunofluorescent assay used with the Sofia 2 fluorescent immunoassay analyzer for the qualitative detection of the nucleocapsid protein antigen of SARS-CoV-2 in nasal swab specimens from symptomatic individuals when testing is started within six days of symptom onset.
 
“As the first company to introduce a rapid antigen test for COVID-19 when the FDA granted Emergency Use Authorization for the Sofia SARS Antigen FIA in May of 2020, we are pleased to again be the first to receive De Novo FDA clearance for our Sofia 2 SARS Antigen+ FIA,” Douglas Bryant, president and CEO of QuidelOrtho Corporation told the press. “With this De Novo authorization, Sofia becomes the predicate device upon which subsequent devices of the same type and intended use will be compared. This designation is a tribute to the incredible ingenuity, commitment to quality, and cohesion of our entire QuidelOrtho team from R&D and regulatory affairs, to design, manufacturing, labeling and packaging. It is a spirit that sustained us through the darkest days of the pandemic and will assure that our rapid testing technologies remain at the forefront of prevention as COVID-19 transitions to its endemic stage.”
 
The Sofia 2 analyzer uses QuidelOrtho’s fluorescent chemistry design, graphical user interface, and optics system to provide an accurate, objective, and automated result in 10 minutes. The Sofia 2 system also comes connected to Virena, QuidelOrtho’s data management system, which provides aggregated, de-identified testing and surveillance data in near real time.
 
The enhanced Sofia 2 SARS Antigen+ FIA Test kit includes other upgraded features, such as prefilled reagent vials, improved ergonomic sample extraction, and a dropper design for easy dispensing of patient samples into the test cassette sample well. The Sofia 2 instrument also offers two distinct workflows. Depending upon the user’s preferred operational method, Sofia 2 SARS Antigen+ FIA test cartridges are either placed directly inside Sofia 2 for automatically timed test development and results read (WALK AWAY Mode), or test cartridges may be placed on the counter or benchtop for a manually timed test development and then placed into Sofia 2 for immediate results read (READ NOW Mode), which allows users to markedly increase testing throughputs per hour.