Diagnostic solutions provider Quidel has secured authorisation from Health Canada for its Sofia SARS Antigen FIA test for screening of asymptomatic populations with serial testing.
Sofia SARS Antigen FIA is claimed to be the first rapid antigen test to secure Health Canada approval for serial testing to identify active coronavirus infection in both symptomatic and asymptomatic populations.
Quidel’s lateral flow immunofluorescent sandwich assay is designed to be used with Sofia and Sofia 2 instruments for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal (NS) swab specimens directly from individuals.
Quidel president and CEO Douglas Bryant said: “Health Canada’s approval opens the door to true democratization 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 test helps healthcare providers to detect individuals suspecting Covid-19 within the first five days of the onset of symptoms. It is also used for serial testing to screen asymptomatic populations for a minimum every three days or 72 hours.
With positive results agreeing with PCR 96.7% of the time and negative results agreeing 100% of the time, the Sofia SARS Antigen FIA is said to demonstrate better performance within the first five days of the onset of symptoms.
In March, Quidel received an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its QuickVu at-home Covid-19 test.
Patients, with a prescription, are allowed to use the QuickVue at-home test themselves and obtain results within 10 minutes.
The QuickVue at-home Covid-19 test is said to use the same Quidel lateral flow technology.
