CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
“The Sofia 2 Lyme FIA’s 510(k) clearance and CLIA waiver for use on the Sofia 2 instrument will allow health care workers to generate a result in a single office visit, accelerating the time to diagnosis and potential treatment of Lyme disease for the patient. This is another example of our ability to provide simple, cost-effective solutions for physician offices and hospitals that previously had to wait several days for send-out results,” Douglas Bryant, president and chief executive officer of Quidel, said in a press release.
Sofia 2 utilizes the original Sofia’s fluorescent chemistry design while improving on the graphical user interface and optics system to provide an accurate, objective, and automated result in as few as three minutes. The next-generation system comes connected to Virena, Quidel’s data management system, which provides aggregated, de-identified testing data in near real time.