Wednesday, April 19, 2023
Meridian Bioscience announced that the United States Food and Drug Administration (FDA) had granted clearance for the new Curian® Shiga Toxin assay.
The Curian Shiga Toxin assay is designed for use with the Curian analyser. The new assay is a rapid, qualitative, fluorescent immunoassay for the simultaneous detection and differentiation of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test device. It is intended for use with cultures derived from human stool specimens to aid in diagnosing diseases caused by Shiga toxin-producing E. coli (STEC) infections, including non-O157 strains.
Curian Shiga Toxin has a market-leading three-step sample prep workflow and produces fast, objective results that can help laboratorians and clinicians provide an objective Shiga toxin diagnosis to get patients on the correct treatment and back on the road to wellness.
The immunofluorescent technology of the Curian platform provides an objective, rapid Shiga toxin result with an unmatched clinical sensitivity of 100% (Stx1), 100% (Stx2), and specificity of 99.4% (Stx1), 99.5% (Stx2) in prospective samples. Curian Shiga Toxin features a lower limit of detection than traditional rapid immunoassay testing. Combined with LIS connectivity, the Curian solution helps to eliminate subjectivity by reducing user variability related to interpreting and reporting visually based lateral flow test results.
