The Sofia 2 SARS Antigen+ FIA is a prescription use only lateral flow immunofluorescent assay that can be used with the Sofia 2 fluorescent immunoassay analyser for the qualitative detection of the SARS-CoV-2 antigen
Sofia 2 SARS Antigen+ FIA is a lateral flow immunofluorescent assay. (Credit: Louis Reed on Unsplash)
US-based diagnostic testing company QuidelOrtho has received the US Food and Drug Administration (FDA) De Novo authorisation for its new Sofia 2 SARS Antigen+ FIA.
The Sofia 2 SARS Antigen+ FIA is a lateral flow immunofluorescent assay, designed for the qualitative detection of the nucleocapsid protein antigen of SARS-CoV-2.
It is a prescription-use-only test intended to be run on the Sofia 2 fluorescent immunoassay analyser in point-of-care settings.
The test uses direct anterior nasal swab specimens from individuals with symptoms of upper respiratory infection within six days of symptom onset.
The Sofia 2 SARS Antigen+ FIA is indicated for helping the diagnosis of Covid-19 in symptomatic individuals, tested at least twice at 48 hours intervals.
The test can be conducted only by trained clinical laboratory personnel and individuals trained in point-of-care settings with expertise in performing tests using Sofia 2 instruments.
QuidelOrtho president and CEO Douglas Bryant said: “With this De Novo authorisation, 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, labelling 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 analyser uses QuidelOrtho’s unique fluorescent chemistry design, intuitive graphical user interface, and optics system.
It offers accurate and automated results within 10 minutes, which is reduced by 33% compared to the 15-minute processing time in the first-generation Sofia SARS Antigen FIA assay.
In addition, the Sofia 2 system is connected to QuidelOrtho’s data management system, Virena, which provides aggregated, de-identified data in near real-time.
QuidelOrtho said that the enhanced Sofia 2 SARS Antigen+ FIA Test kit comes with upgraded features, such as prefilled reagent vials, improved sample extraction and dropper design.
The Sofia 2 instrument also offers two different workflows, WALK AWAY Mode and READ NOW Mode, based on the user’s preferred operational method.