title: Comparison of five assays for detection of Clostridium difficile toxin.
abstract: Performance characteristics of five assays for detection of Clostridium difficile toxin were compared using fresh stool samples from patients with C. difficile infection (CDI). Assays were performed simultaneously and according to the manufacturers' instructions. Patients were included in the study if they exhibited clinical symptoms consistent with CDI. Nonmolecular assays included glutamate dehydrogenase antigen tests, with positive findings followed by the Premier Toxin A and B Enzyme Immunoassay (GDH/EIA), and the C. Diff Quik Chek Complete test. Molecular assays (PCR) included the BD GeneOhm Cdiff Assay, the Xpert C. difficile test, and the ProGastro Cd assay. Specimens were considered true positive if results were positive in two or more assays. For each method, the Youden index was calculated and cost-effectiveness was analyzed. Of 81 patients evaluated, 26 (32.1%) were positive for CDI. Sensitivity of the BD GeneOhm Cdiff assay, the Xpert C. difficile test, the ProGastro Cd assay, C. Diff Quik Chek Complete test, and two-step GDH/EIA was 96.2%, 96.2%, 88.5%, 61.5%, and 42.3%, respectively. Specificity of the Xpert C. difficile test was 96.4%, and for the other four assays was 100%. Compared with nonmolecular methods, molecular methods detected 34.7% more positive specimens. Assessment of performance characteristics and cost-effectiveness demonstrated that the BD GeneOhm Cdiff assay yielded the best results. While costly, the Xpert C. difficile test required limited processing and yielded rapid results. Because of discordant results, specimen processing, and extraction equipment requirements, the ProGastro Cd assay was the least favored molecular assay. The GDH/EIA method lacked sufficient sensitivity to be recommended.
authors.affiliation: Department of Pathology, Rhode Island Hospital, Providence, Rhode Island; Department of Medicine, Rhode Island Hospital, Providence, Rhode Island, USA. Kchapin@lifespan.org
authors.forename: Kimberle C
authors.initials: KC
authors.lastname: Chapin
authors.forename: Roberta A
authors.initials: RA
authors.lastname: Dickenson
authors.forename: Fongman
authors.initials: F
authors.lastname: Wu
authors.forename: Sarah B
authors.initials: SB
authors.lastname: Andrea
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001426:Bacterial Proteins / Q000737:chemistry*; D001427:Bacterial Toxins / Q000737:chemistry*; D002648:Child; D002675:Child, Preschool; D016360:Clostridioides difficile; D003362:Cost-Benefit Analysis; D004761:Enterocolitis, Pseudomembranous / Q000175:diagnosis*; D004768:Enterotoxins / Q000737:chemistry*; D005243:Feces / Q000737:chemistry / Q000382:microbiology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000191:economics / Q000379:methods*; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D001426:Bacterial Proteins; D001427:Bacterial Toxins; D004768:Enterotoxins; C041348:tcdA protein, Clostridium difficile; C031815:toxB protein, Clostridium difficile