13th November 2012 Content supplied by: Quidel Corporation
Quidel Gets CE Mark for Sofia® Legionella Fluorescent Immunoassay
Quidel Corporation has received the CE Mark for its Sofia Legionella FIA for use on the Sofia Analyzer for the rapid detection of Legionnaires' disease, also known as legionellosis.
Sofia is the brand name for Quidel's next generation, immunoassay system that was launched earlier this year. The Sofia Analyzer and Sofia Legionella FIA combine unique immunofluorescence chemistry, advanced lateral flow technology, and failure alert and fail-safe systems designed to ensure a reliable, objective, highly accurate, diagnostic result within ten minutes of application of the patient's specimen. The Sofia system was 510(k) cleared in October of 2011, and its first test, the Sofia Influenza A+B FIA, received Clinical Laboratory Improvement Amendments (CLIA) waiver by the U.S. FDA in April of 2012.
The CE Mark allows Quidel to launch its new Sofia Legionella FIA in Europe.
The Sofia Legionella assay uses the Sofia Analyzer, an instrument that is designed to easily incorporate new analyte-specific algorithms -- an important feature as the Sofia menu of products expands. The other Sofia immunoassays presently for sale in Europe include FIAs for Influenza A+B, Strep A and RSV.
Date Published: 13th November 2012