The test will help diagnose SARS-CoV-2 infections in symptomatic individuals. Credit: Thomas G. / Pixabay.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The 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.”