title: 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.
abstract: 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.
authors.affiliation: Nationwide Children's Hospital, Department of Laboratory Medicine, Columbus, OH, USA. Electronic address: stella.antonara@nationwidechildrens.org.
authors.forename: Stella
authors.initials: S
authors.lastname: Antonara
authors.affiliation: Primary Children's Medical Center, University of Utah, Salt Lake City, UT, USA.
authors.forename: Judy
authors.initials: J
authors.lastname: Daly
authors.affiliation: Penn State Hershey Medical Center, Hershey, PA, USA.
authors.forename: W
authors.initials: W
authors.lastname: Greene
authors.affiliation: Nationwide Children's Hospital, Department of Laboratory Medicine, Columbus, OH, USA; Department of Pediatrics & Pathology, The Ohio State University College of Medicine, Columbus, OH, USA.
authors.forename: Amy
authors.initials: A
authors.lastname: Leber
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001427:Bacterial Toxins / Q000235:genetics*; D002648:Child; D002675:Child, Preschool; D016360:Clostridioides difficile / Q000235:genetics*; D003015:Clostridium Infections / Q000139:chemically induced / Q000175:diagnosis*; D003967:Diarrhea / Q000139:chemically induced / Q000175:diagnosis*; D005243:Feces / Q000382:microbiology*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D013997:Time Factors; D014481:United States; D055815:Young Adult
chemical_list: D001427:Bacterial Toxins
keywords: AmpliVue; Clostridium difficile; Illumigene; Molecular detection methods