March 13, 2023 – QuidelOrtho announced that it has been granted a de novo request from the 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 analyzer utilizes QuidelOrtho’s proprietary fluorescent chemistry design, intuitive graphical user interface, and optics system to provide an accurate, objective and automated result in just 10 minutes, a 33% reduction from the breakthrough 15-minute processing time achieved in the first iterations of the Sofia SARS Antigen FIA assay. 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.
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 disease.
A negative test is presumptive, and it is recommended these results be confirmed by a molecular SARS-CoV-2 assay. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions.