The assay is said to be a rapid, qualitative, fluorescent immunoassay designed to simultaneously detect and differentiate Shiga toxin 1 and Shiga toxin 2 in a single test device
Meridian Bioscience has secured clearance from the US Food and Drug Administration (FDA) for its new Curian Shiga Toxin assay.
Designed for use with the Curian analyser, the Curian Shiga Toxin assay is said to be a rapid, qualitative, fluorescent immunoassay.
The US-based diagnostic testing solutions provider has developed the assay to simultaneously detect and differentiate Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test device.
It is designed to be used with cultures made from human stool samples to help diagnose illnesses caused by infections with Shiga toxin-producing E. coli (STEC), including non-O157 strains.
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.”
The new assay joins Curian HpSA and Curian Campy.
The diagnostic testing solutions provider is expanding its Curian diagnostic platform to maintain its position in the market for gastrointestinal disease testing.
Meridian Bioscience has added the Shiga Toxin assay to the Curian platform to expand its foodborne immunofluorescent testing capabilities beyond Campylobacter.
The Curian platform’s immunofluorescent technology offers an objective and quick Shiga toxin result with a clinical sensitivity of 100% (Stx1), 100% (Stx2), and specificity of 99.4% (Stx1), 99.5% (Stx2) in prospective samples.
The Curian Shiga Toxin assay has a lower limit of detection in comparison to conventional fast immunoassay testing.
When integrated with LIS connectivity, the Curian system reduces user variability related to interpreting and reporting visually-based lateral flow test findings in order to eliminate subjectivity.
In August last year, the company obtained the FDA’s emergency use authorisation (EUA) for its Revogene SARS-COV-2 molecular assay.