Diagnostic testing solutions provider Meridian Bioscience has received approval from the US Food and Drug Administration (FDA) for its new Curian Shiga Toxin assay.
The new assay is part of the company’s Curian diagnostic platform, which also includes Curian HpSA and Curian Campy assays.
The addition of Shiga toxin to the Curian platform enables the company to expand its foodborne immunofluorescent testing capabilities beyond Campylobacter.
Meridian Bioscience diagnostics president Tony Serafini-Lamanna said: “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.”
Designed for use with the Curian analyser, the new rapid, qualitative and fluorescent immunoassay can simultaneously detect and differentiate Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test device.
The new assay is used with cultures obtained from human stool specimens to help diagnose diseases caused by Shiga toxin-producing E. coli (STEC) infections, including non-O157 strains.
Curian platform’s immunofluorescent technology offers rapid Shiga toxin result with a clinical sensitivity of 100% for Stx1, 100% for Stx2 and specificity of 99.4% for Stx1 and 99.5% for Stx2 in prospective samples.
In July last year, the US FDA re-authorised the emergency use authorisation for the company’s Revogene SARS-CoV-2 molecular assay.
Meridian offers diagnostic solutions for gastrointestinal and upper respiratory infections, as well as blood lead level testing.