FDA clears Meridian Bioscience’s Shiga Toxin test, expanding GI testing platform
Click Here to Manage Email Alerts
Meridian Bioscience has announced FDA 510(k) clearance of its Curian Shiga Toxin assay intended for detection and differentiation of Shiga toxin 1 and 2 within a single device, according to a company release.
By adding Shiga toxin detection, the company has expanded the platform’s foodborne immunofluorescent testing capabilities beyond Campylobacter.
“We are excited to continue the expansion of the Curian platform with this highly sensitive and specific assay,” Tony Serafini-Lamanna, president of Meridian Bioscience Diagnostics, said in the release. “Curian now features the broadest menu of [gastrointestinal] tests on an immunoassay analyzer.”
He added: “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.”
According to the release, a quick diagnosis for Shiga toxin-producing Escherichia coli infection is essential because antibiotic use can increase release of Shiga toxin, which may lead to hemolytic uremic syndrome.
The FDA based its clearance on objective and rapid results which demonstrated a clinical sensitivity of 100% for both Shiga toxin 1 and Shiga toxin 2 and specificity of 99.4%.
The company noted that the Curian Shiga toxin assay should be used in conjunction with the Curian analyzer and cultures derived from stool specimens to diagnose diseases caused by Shiga toxin-producing E. coli infections, including non-O157 strains.
Collapse
Press Release
Click Here to Manage Email Alerts