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