Quidel Corporation (San Diego, CA) announced it has received an amended Emergency Use Authorization (EUA) from the 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.
“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 CEO 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.”
Healthcare professionals can purchase the Sofia SARS Antigen FIA through distribution representatives for Cardinal Health, Fisher Healthcare, Henry Schein, McKesson, or Medline.