Fluorescent Immunoassay Rapidly Detects Group A Streptococcus Infections

The Sofia Analyzer and Sofia Strep A FIA combine immunofluorescence chemistry, advanced lateral flow technology, and failure alert and fail-safe systems designed to ensure a reliable, objective, accurate, diagnostic result within five minutes of application of the patient's specimen.

Sofia is the brand name given to Quidel's next-generation, immunoassay system. Quidel Corp. (San Diego, CA, USA) provider of rapid diagnostic testing solutions, cell-based virology assays, and molecular diagnostic systems, announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA; Atlanta, GA, USA) for the Sofia Strep A FIA for use on the Sofia Analyzer for the rapid, objective detection of infections by Group A Strep. The clearance allows Quidel to market and sell its new Sofia Strep A FIA in the United States.

The Sofia Analyzer was 510(k) cleared in October 2011, and its first test, the Sofia Influenza A+B FIA, received Clinical Laboratory Improvement Amendments (CLIA) waiver by the US FDA in April 2012.

Douglas Bryant, president and chief executive officer of Quidel Corporation, said, "In the short-term, the clearance of the Sofia Strep A FIA provides us with another catalyst for increasing Sofia placements in the field, and before the onset of the upcoming respiratory disease season. Over the long-term, our premium product addresses a market that, relative to influenza, represents a higher volume opportunity with less seasonality and less volatility."

Related Links:
Quidel Corp.
United States Food and Drug Administration