Health Canada Approves Quidel’s Sofia SARS Antigen FIA Test
By Business Wire | 07.30.21
Assay is used for serial testing to detect active coronavirus infection in both symptomatic and asymptomatic populations.
Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, 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 three 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 percent of the time, and negative results agreeing 100 percent 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
“Quidel is proud to bring our most innovative and sensitive COVID-19 testing technologies to the Canadian market and make our tests as widely available as possible,” said Douglas Bryant, president and CEO of Quidel Corporation. “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.”
Quidel Corporation is a manufacturer of diagnostic solutions at the point of care, delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe. An innovator for over 40 years in the medical device industry, Quidel pioneered the first U.S. Food and Drug Administration-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the United States. Under trusted brand names Sofia, Solana, Lyra, Triage, and QuickVue, Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19.
Reference
1 https://www.medrxiv.org/content/10.1101/2021.03.19.21253964v2
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 three 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 percent of the time, and negative results agreeing 100 percent 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
“Quidel is proud to bring our most innovative and sensitive COVID-19 testing technologies to the Canadian market and make our tests as widely available as possible,” said Douglas Bryant, president and CEO of Quidel Corporation. “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.”
Quidel Corporation is a manufacturer of diagnostic solutions at the point of care, delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe. An innovator for over 40 years in the medical device industry, Quidel pioneered the first U.S. Food and Drug Administration-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the United States. Under trusted brand names Sofia, Solana, Lyra, Triage, and QuickVue, Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19.
Reference
1 https://www.medrxiv.org/content/10.1101/2021.03.19.21253964v2
