Quidel receives CE Mark for Sofia Quantitative Vitamin D assay
Quidel Corporation announced it has received CE Mark for its Sofia Quantitative Vitamin D FIA for use with the Sofia fluorescent immunoassay analyzer for the quantitative determination of total 25-OH vitamin D from serum samples. The test is intended for use with the Sofia analyzer to aid in the assessment of Vitamin D sufficiency and is the first quantitative assay on Sofia. Sofia is the brand name for Quidel's flagship product, an instrumented immunoassay system. The easy-to-use first-generation Sofia analyzer and its companion assays combine unique software and fluorescent chemistry to yield an automatic, objective result that is readily available on the instrument's screen, in a hard-copy printout, and in a transmissible electronic form that can network via an LIS system to hospital and medical center databases. The Sofia analyzer along with the Sofia Quantitative D FIA provide reliable diagnostic results within 10 minutes of processing the patient's serum sample.