QuidelOrtho has received De Novo authorisation from the US Food and Drug Administration (FDA) for its Sofia 2 SARS Antigen+ FIA test.
Intended for prescription use only, the rapid antigen test helps identify Covid-19 infection and is suitable for use in point-of-care settings.
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The lateral flow immunofluorescent assay is designed to be used with the Sofia 2 fluorescent immunoassay analyser for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swab specimens.
Specimens are collected within six days of symptom onset from individuals with signs and symptoms of upper respiratory infection.
When tested at least twice over three days, with a gap of at least 48 hours between tests, the Sofia 2 test will help diagnose SARS-CoV-2 infections in individuals with symptoms.
To offer precise, objective and automated results within 10 minutes, the Sofia 2 analyser uses the firm’s fluorescent chemistry design, graphical user interface and optics system.
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By GlobalDataThe Sofia 2 system can also be connected to QuidelOrtho’s Virena data management system for the delivery of aggregated, de-identified testing and surveillance data in near real time.
Furthermore, the enhanced Sofia 2 SARS Antigen+ FIA Test kit includes other upgraded features, such as prefilled reagent vials, improved sample extraction and a dropper design for easily dispensing patient samples into the test cassette sample well.
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.”
