May 25, 2021 – Quidel Corporation (San Diego, CA) announced that its Sofia SARS Antigen FIA is the first rapid antigen test to receive authorization from Health Canada for serial testing for the detection of active coronavirus infection in both symptomatic and asymptomatic populations.
The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms, or serial testing of asymptomatic populations using the Sofia SARS Antigen FIA test, at a minimum every 3 days/72 hours.
The Sofia SARS Antigen FIA shows excellent performance within the first five days of the onset of symptoms, with positive results agreeing with PCR 96.7% of the time, and negative results agreeing 100% of the time, the company says.
This new intended use claim allows the Sofia SARS Antigen FIA to be used among asymptomatic individuals throughout Canada provided that individuals test at least every three days, or 72 hours.
“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,” said Douglas Bryant, president and CEO of Quidel Corporation.