title: Comparison of two commercially available enzyme immunoassays for detection of Clostridium difficile in stool specimens.
abstract: Clostridium difficile is the cause of most cases of pseudomembranous colitis, the most severe form of antibiotic-associated diarrhea. Rapid diagnosis guides both the treatment and the control of nosocomial spread of infection. Two enzyme immunoassay (EIA) kits developed for the rapid detection of C. difficile toxin A in fecal specimens, Premier (Meridian Diagnostics, Cincinnati, Ohio) and Tox-A test (TechLab, Virginia Polytechnic Institute Research Park, Blacksburg), were evaluated by using 410 fecal specimens. Seventy-six specimens were positive for C. difficile toxin B by the cytotoxin assay (prevalence rate, 19%). The Meridian EIA was positive for 71 of the 76 samples, yielding a sensitivity of 93%. The TechLab EIA detected 75 of the 76 positive samples, yielding a sensitivity of 99%. The Meridian and TechLab EIAs had specificities of 100 and 93%, respectively. These data indicate that both EIAs are suitable alternatives to the cytotoxin assay in routine diagnostic laboratories. However, confirmation of TechLab EIA-positive test results by the cytotoxin assay remains necessary.
authors.affiliation: Department of Pediatrics, School of Medicine and Biomedical Sciences, State University of New York, Buffalo.
authors.forename: S S
authors.initials: SS
authors.lastname: Altaie
authors.forename: P
authors.initials: P
authors.lastname: Meyer
authors.forename: D
authors.initials: D
authors.lastname: Dryja
mesh_terms: D000293:Adolescent; D000328:Adult; D001426:Bacterial Proteins; D001427:Bacterial Toxins / Q000302:isolation & purification; D002648:Child; D002675:Child, Preschool; D016360:Clostridioides difficile / Q000302:isolation & purification*; D004761:Enterocolitis, Pseudomembranous / Q000382:microbiology*; D004768:Enterotoxins / Q000302:isolation & purification; D005243:Feces / Q000382:microbiology*; D006801:Humans; D007124:Immunoenzyme Techniques; D011933:Reagent Kits, Diagnostic; D013048:Specimen Handling
chemical_list: D001426:Bacterial Proteins; D001427:Bacterial Toxins; D004768:Enterotoxins; D011933:Reagent Kits, Diagnostic; C041348:tcdA protein, Clostridium difficile; C031815:toxB protein, Clostridium difficile