title: Comparison of the Verigene Clostridium difficile, Simplexa C. difficile Universal Direct, BD MAX Cdiff, and Xpert C. difficile assays for the detection of toxigenic C. difficile.
abstract: We compared the Verigene Clostridium difficile test (Nanosphere, Northbrook, IL, USA), the Simplexa C. difficile Universal Direct (Focus Diagnostics, Cypress, CA, USA), the BD MAX Cdiff (Becton Dickinson, Franklin Lakes, NJ, USA), and the Xpert C. difficile (Cepheid, Sunnyvale, CA, USA) assays for the detection of toxigenic C. difficile. One hundred and ninety deidentified, remnant diarrheal specimens were included in this study. After resolution of discordant results by toxigenic culture, the Xpert C. difficile assay displayed the highest sensitivity (100%), with a specificity of 98.8%. The sensitivity and specificity were 95.2% and 99.4% and 87% and 100% for the Verigene CDF and Simplexa Universal Direct assays, respectively. Finally, the BD MAX assay showed a sensitivity of 87% and a specificity of 98.8%. Despite differences in the overall performance of these assays, these results support the routine use of these platforms for the detection of toxigenic C. difficile in the clinical laboratory.
authors.affiliation: Department of Laboratory Medicine, University of Washington, Seattle, WA 98195.
authors.forename: Jeremy J
authors.initials: JJ
authors.lastname: Gilbreath
authors.affiliation: Department of Pathology and Clinical Laboratories, Virginia Mason Medical Center, Seattle, WA 98101.
authors.forename: Punam
authors.initials: P
authors.lastname: Verma
authors.affiliation: Department of Laboratory Medicine, University of Washington, Seattle, WA 98195.
authors.forename: April N
authors.initials: AN
authors.lastname: Abbott
authors.affiliation: Department of Laboratory Medicine, University of Washington, Seattle, WA 98195. Electronic address: butlerwu@uw.edu.
authors.forename: Susan M
authors.initials: SM
authors.lastname: Butler-Wu
mesh_terms: D016360:Clostridioides difficile / Q000235:genetics*; D003015:Clostridium Infections / Q000175:diagnosis* / Q000382:microbiology*; D004269:DNA, Bacterial / Q000032:analysis; D005243:Feces / Q000382:microbiology; D005798:Genes, Bacterial / Q000235:genetics; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D012680:Sensitivity and Specificity
chemical_list: D004269:DNA, Bacterial
keywords: CDI; Clostridium difficile; Molecular diagnostics; RT-PCR; tcdB