FDA clears Quidel's Sofia Strep A+ immunoassay for rapid detection of group A Streptococcus

Quidel announced that its Sofia Strep A+ fluorescent immunoassay received FDA 510(k) clearance for use with the Sofia 2 fluorescent immunoassay analyser to rapidly detect infections by group A Streptococcus bacteria. CEO Douglas Bryant remarked that "with the clearance of Sofia Strep A+, Sofia 2 now provides clinicians at the point-of-care with a…diagnostic tool that quickly and accurately diagnoses three of the more common respiratory diseases: Influenza A+B, RSV and Strep A."

According to Quidel, the Sofia Strep A+ assay uses "advanced lateral flow and immunofluorescence technologies to provide enhanced clinical sensitivity for group A Streptococcus," which ensure a "reliable, objective, rapid, and accurate diagnostic result." Meanwhile, Sofia 2 uses the same fluorescent chemistry design found in the original Sofia version, but improves "upon the graphical user interface and optics system to provide an accurate, automated and objective result in five minutes," Quidel said. The company added that the next-generation Sofia system is also connected to its Virena data management system, "which provides aggregated, de-identified testing data in near real-time."

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