Publications & Posters

Design Of A Two-Plex Assay For Detection Of Clostridium Difficile Toxins A And B


Banz Alice, Riou Brigitte, Lantz Aude, Foussadier Agnès, bioMérieux, Marcy L’Etoile, France

Introduction and Objective:

Clostridium difficile infection (CDI) is an inflammation of the large intestine due to an infection with a spore-forming bacteria, C. difficile, causing diarrhea. It is a healthcare-associated disease linked to the use of antibiotics. Infection with C. difficile species is common, serious, and costly. The presence of C. difficile toxin in fecal samples is the most reliable indicator of true CDI, but immunoassays for toxin testing are not suitable as stand-alone tests due to a lack of sensitivity. All guidelines strongly recommend a two-step assay algorithm based on the detection of bacteria followed by toxin detection. Since 2010, many laboratories are performing molecular assays for toxin gene detection and an increase in CDI incidence has been observed. Nevertheless, the presence of genes does not always correlate with the presence of functional toxins, leading to an inability to distinguish a disease state from colonization. An automated 1-step assay with high sensitivity for C. difficile toxins could strongly improve the accuracy of CDI diagnosis and reduce costs.The objective of this study was to evaluate a quantitative assay using the SimoaTM technology for simultaneous detection of toxins A and B of C. difficile in human fecal samples.