QuidelOrtho, a provider of in vitro diagnostic technologies designed for point-of-care settings, clinical labs, and transfusion medicine, has been granted a De Novo request from the U.S. Food and Drug Administration (FDA), allowing the company to market its new Sofia 2 SARS Antigen+ FIA. 

The Sofia 2 SARS Antigen+ FIA is the first rapid antigen test that detects COVID-19 to be awarded FDA market clearance. The test is intended for prescription use only and can be used in point-of-care settings.

The Sofia 2 SARS Antigen+ FIA is a lateral flow immunofluorescent assay that is used with the Sofia 2 fluorescent immunoassay analyzer intended for the qualitative detection of the nucleocapsid protein antigen of SARS-CoV-2 in direct anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., symptomatic) when testing is started within six days of symptom onset. 

The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when tested at least twice over three days with at least 48 hours between tests. The Sofia 2 SARS Antigen+ FIA is intended for use by trained clinical laboratory personnel and individuals trained in point-of-care settings and proficient in performing tests using Sofia 2 instruments.

“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,” says Douglas Bryant, president and CEO of QuidelOrtho Corporation. “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 is designed to provide an accurate, objective, and automated result in just 10 minutes, a 33% reduction from the 15-minute processing time achieved in the first iterations of the Sofia SARS Antigen FIA assay, the company says. 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.

An Improved SARS Antigen Test

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 improved 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, 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, which allows users to markedly increase testing throughputs per hour.

Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens of SARS-CoV-2, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses, as the agent detected may not be the definite cause of the disease.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions.