Health Canada Approves Quidel’s Sofia® SARS Antigen FIA Test for Screening of Asymptomatic Populations With Serial Testing

Excerpt from the Press Release:

SAN DIEGO–(BUSINESS WIRE)–Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today 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.

he 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, delivering confidence to physicians, healthcare workers and other customers within the professional segment. 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. Routine testing by rapid antigen tests has shown to be effective in diagnosing COVID-19.¹

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