The Sofia SARS Antigen FIA is intended to be used with the Sofia and Sofia 2 instrument. Credit: Waldemar Brandt on Unsplash.

Health Canada has authorised Quidel’s Sofia SARS Antigen FIA for serial testing to identify active Covid-19 infection in symptomatic and asymptomatic people.

A lateral flow immunofluorescent sandwich assay, the Sofia SARS Antigen FIA is intended to be used with the Sofia and Sofia 2 instrument.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The rapid antigen test is indicated for the qualitative identification of the SARS-CoV-2 nucleocapsid protein antigen in nasal swab samples obtained from people suspected of Covid-19 by a healthcare worker within five days of symptom onset.

It can also be used for serial testing of asymptomatic people at least every three days or 72 hours.

Demonstrating significant performance within five days from the development of symptoms, the test had 96.7% positive result agreement with polymerase chain reaction (PCR) and negative result agreement of 100%.

The latest intended use claim facilities use of the test for asymptomatic people in Canada. Quidel noted that routine testing with rapid antigen tests has demonstrated effectiveness in Covid-19 detection.

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.

Quidel president and CEO Douglas Bryant said: “Health Canada’s approval opens the door to true democratisation of the benefits of serial testing for both individuals experiencing symptoms and screening of people who may not have symptoms but are actively shedding the virus.

“Broadscale application of our Sofia rapid antigen test for Covid-19 screening across Canada will catch asymptomatic cases early and limit virus spread and is an important tool to get Canadians back to work and getting the economy fully open again.”

The latest development comes after Quidel announced that its prescription-free QuickVue At-Home OTC COVID-19 Test has been made available for online sale in the US through Amazon.

Earlier this month, Quidel entered a retail partnership with Walgreens to provide the QuickVue test to users at 7,600 Walgreens sites in the US and Puerto Rico.