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18th June 2020  Content supplied by: Quidel Corporation

Quidel Receives Amended FDA-EUA for Rapid Antigen COVID-19 Diagnostic Assay 


Quidel has received an amended Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), allowing Quidel to run its Sofia® SARS Antigen FIA, a rapid point-of-care test for COVID-19, on the Sofia® Fluorescent Immunoassay Analyzer (“Sofia 1”), Quidel’s first-generation automated immunoassay instrument.

Quidel previously received EUA to run the Sofia SARS Antigen FIA on the second-generation Sofia 2 instrumented system.

Sofia 1 is Quidel’s first-generation instrumented system, which provides an accurate, objective and automated result in 15 minutes.

Like the Sofia 2, the original Sofia 1 instrument offers two distinct workflows: depending upon the user’s choice, the Sofia SARS Antigen FIA cartridge is placed inside the instrument for automatically timed development (WALK AWAY Mode); or test cartridges can be placed on the counter or benchtop for a manually timed development and then placed into the instrument to be scanned (READ NOW Mode), allowing the user to markedly increase testing throughput per hour. There are approximately 20,000 Sofia 1 instruments installed in hospitals and physician offices worldwide.

“This EUA amendment permits our novel Sofia® SARS Antigen test to be used on both models of our Sofia instruments, leveraging our worldwide installed base of over 43,000 combined placements, allowing many of our larger healthcare facilities to be able to quickly diagnose first responders, healthcare workers, and other high priority personnel,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “The demand for the Sofia SARS Antigen test kits and Sofia instruments has been phenomenal. In under 10 days, we had over 1,000 sites on contract and continue to expect that we will ship every cartridge that we can manufacture for the foreseeable future.”

The Sofia SARS Antigen FIA is to be used as an aid in the rapid detection of SARS-CoV-2 in nasal or nasopharyngeal specimens from patients meeting the Centers for Disease Control and Prevention’s (CDC) criteria for suspected COVID-19 infection.

The assay is currently available for sale in the United States under EUA, and Quidel is now shipping the product to its customers. Quidel offers several other Sofia assays for sale, which are FDA cleared and CLIA waived, including tests for Influenza A and B, Respiratory Syncytial Virus (RSV), Group A Strep, and a 15-minute finger-stick whole blood test for Lyme Disease. In addition, Quidel also markets Sofia® tests for Lyme Disease, Legionella and S. pneumoniae in Europe.

Healthcare professionals can purchase the Sofia SARS Antigen FIA through distribution representatives for Cardinal Health, Fisher Healthcare, Henry Schein, McKesson, or Medline.

Please use the 'Request Information' button provided below for further information. 


    

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Date Published: 18th June 2020

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