title: Evaluation of an automated rapid diagnostic test for detection of Clostridium difficile.
abstract: The Verigene Clostridium difficile Nucleic Acid Test (Verigene CDF Test) (Nanosphere, Northbrook, IL, USA) is a new multiplex qualitative polymerase chain reaction (PCR) test used to detect C. difficile toxin genes in fecal specimens. To evaluate the performance of the new method, we tested 69 fecal samples from patients with suspected C. difficile infection using the Verigene CDF test, an enzyme immunoassay (EIA) and PCR following anaerobic fecal culture. The sensitivity, specificity, and accuracy of the Verigene CDF test were 96.7% (29/30), 97.4% (38/39), and 97.1% (67/69) respectively, using PCR following fecal culture as a reference method. We also analyzed the potential clinical impact of the Verigene CDF test using chart reviews of the 69 patients with suspected C. difficile infection and found that 11 of the 69 patients were incorrectly diagnosed, and the Verigene CDF test would have led to them receiving more appropriate management including practice of treatment and contact precaution, although, of the 69 patients, there are two whose samples were incorrectly identified with the Verigene CDF test. The Verigene CDF test will have a positive impact on patient care.
authors.affiliation: Department of Anatomy and Embryology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan; Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo, Japan; Department of Infectious Diseases, Research Institute, National Center for Global Health and Medicine, Tokyo, Japan.
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Tojo
authors.affiliation: Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo, Japan; Department of Infectious Diseases, Research Institute, National Center for Global Health and Medicine, Tokyo, Japan.
authors.forename: Maki
authors.initials: M
authors.lastname: Nagamatsu
authors.affiliation: Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo, Japan.
authors.forename: Kayoko
authors.initials: K
authors.lastname: Hayakawa
authors.affiliation: Department of Clinical Laboratory, National Center for Global Health and Medicine, Tokyo, Japan.
authors.forename: Kazuhisa
authors.initials: K
authors.lastname: Mezaki
authors.affiliation: Department of Infectious Diseases, Research Institute, National Center for Global Health and Medicine, Tokyo, Japan.
authors.forename: Teruo
authors.initials: T
authors.lastname: Kirikae
authors.affiliation: Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo, Japan.
authors.forename: Norio
authors.initials: N
authors.lastname: Ohmagari
mesh_terms: D001426:Bacterial Proteins / Q000235:genetics; D001427:Bacterial Toxins / Q000235:genetics; D001431:Bacteriological Techniques / Q000379:methods*; D016360:Clostridioides difficile / Q000235:genetics*; D003955:Diagnostic Tests, Routine / Q000379:methods*; D004761:Enterocolitis, Pseudomembranous / Q000175:diagnosis*; D004768:Enterotoxins / Q000235:genetics; D005243:Feces / Q000382:microbiology; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods; D060885:Multiplex Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity
chemical_list: D001426:Bacterial Proteins; D001427:Bacterial Toxins; D004768:Enterotoxins