Streptococcus Assay Released Before Respiratory Disease Season in Europe

A Streptococcus A assay combines fluorescent chemistry, advanced lateral flow technology, and failure alert and fail-safe systems to ensure a reliable, objective, rapid, and highly accurate diagnostic result.

The Sofia Strep fluorescent immunoassay (FIA) is a next generation system for use with the Sofia Analyzer. On October 26, 2011 the Sofia Analyzer and Sofia Influenza A+B FIA received clearance by the Food and Drug Administration (FDA; Silver Spring, MD. USA); Quidel Corp. (San Diego, CA, USA), the company which produces the Sofia Analyzer, has now received the CE Mark for the Sofia Strep A FIA. The Strep A FIA is the second assay to incorporate Sofia-related immunochemistry.

"We are very pleased to receive the CE Mark for Strep A on Sofia ahead of schedule. In combination with our Sofia Influenza A+B FIA, this product will provide healthcare workers with added testing versatility during this respiratory disease season," said Douglas Bryant, president and chief executive officer of Quidel Corporation.

Both the Sofia Strep A and Influenza A+B FIAs use the Sofia Analyzer, an instrument that is designed to quickly incorporate software upgrades for new analyte-specific algorithms as the Sofia menu of products expands. Several additional FIAs for application to the Sofia Analyzer are being developed.

Quidel Corporation products are marketed under the QuickVue, D3 Direct Detection, and Thyretain brand names, as well as under the new Sofia and Quidel Molecular brands. Its products aid in the detection and diagnosis of many critical diseases and conditions, including influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease, and fecal occult blood.

Related Links:
Food and Drug Administration
Quidel Corp.