A large scale clinical evaluation of the AmpliVue and Illumigene molecular tests for the identification of Clostridium difficile-associated diarrhea in adult and pediatric patients

The AmpliVue (Quidel, San Diego, CA, USA) and Illumigene (Meridian Biosciences, Cincinnati, OH, USA) molecular tests were compared for the detection of C. difficile toxin in fresh fecal samples from adult and pediatric patients. A total of 758 samples were collected, in 3 clinical sites: Nationwide Children's (Columbus, OH, USA), Penn State Hershey (Hershey, PA, USA), Primary Children's (Salt Lake City, UT, USA). Each site tested the fecal specimens using both assays. Any discordant results were resolved by performing toxigenic culture. There were 16 discordant samples among the 3 sites. Following discordant resolution, the combined performance for all 3 sites for sensitivity, specificity, PPV, and NPV for AmpliVue was 96.1%, 99.2%, 96.1%, and 99.2%, respectively, while for Illumigene was 96.1%, 99.8%, 99.2%, and 99.2%, respectively. The AmpliVue and Illumigene methods are both relatively rapid and simple to use, sensitive, and specific for detection of C. difficile toxin and demonstrate similar performance.