FDA awards clearance to Meridian Bioscience for Curian Shiga Toxin assay
pharmafile | April 21, 2023 | News story | Medical Communications |
Meridian Bioscience, a US-based diagnostic testing solutions provider, has announced that the FDA has given clearance for its new Curian Shiga Toxin assay.
The Curian Shiga Toxin assay is a rapid, qualitative, fluorescent immunoassay, designed to be used with the Curian analyser. It can detect and differentiate Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test device from human stool samples, which aids in diagnosing Shiga toxin-producing E. coli (STEC) diseases. It provides clinical sensitivity of 100% for both Stx1 and Stx2, and specificity of 99.4% (Stx1) and 99.5% (Stx2).
The Curian analyser can also be used with Curian HpSA and Curian Campy, making the Curian Shiga Toxin assay the most recent to join Meridian’s Curian diagnostic platform for gastrointestinal diseases. The Curian system can also reduce user variability when combined with LIS connectivity by interpreting and reporting visually-based lateral flow rest results.
Tony Serafini-Lamanna, president of Meridian Bioscience Diagnostics, stated: “We are excited to continue the expansion of the Curian platform with this highly sensitive and specific assay. Curian now features the broadest menu of GI tests on an immunoassay analyser. 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.”
James Spargo






