title: Prospective multicenter evaluation of a new immunoassay and real-time PCR for rapid diagnosis of Clostridium difficile-associated diarrhea in hospitalized patients.
abstract: In a prospective multicenter study, 367 fecal samples from 300 patients with diarrhea were tested for Clostridium difficile-associated diarrhea (CDAD) with a new immunochromatography assay for toxins A and B (ICTAB), a real-time PCR on the toxin B gene, and the cell cytotoxicity assay. Twenty-three (6.2%) of the 367 fecal samples were positive by the cell cytotoxicity assay. With the cell cytotoxicity assay as the "gold standard," the sensitivity, specificity, positive predictive value, and negative predictive value for the ICTAB assay and real-time PCR were 91, 97, 70, and 99%, and 87, 96, 57 and 99%, respectively. In conclusion, both the ICTAB and the real-time PCR can be implemented as rapid screening methods for patients suspected of having CDAD.
authors.affiliation: Department of Medical Microbiology, Center of Infectious Diseases, Leiden University Medical Center, 2300 RC Leiden, The Netherlands.
authors.forename: Renate J
authors.initials: RJ
authors.lastname: van den Berg
authors.forename: Lesla S
authors.initials: LS
authors.lastname: Bruijnesteijn van Coppenraet
authors.forename: Hendrik-Jan
authors.initials: HJ
authors.lastname: Gerritsen
authors.forename: Hubert P
authors.initials: HP
authors.lastname: Endtz
authors.forename: Eric R
authors.initials: ER
authors.lastname: van der Vorm
authors.forename: Ed J
authors.initials: EJ
authors.lastname: Kuijper
mesh_terms: D000046:Academic Medical Centers; D001426:Bacterial Proteins / Q000032:analysis / Q000235:genetics; D001427:Bacterial Toxins / Q000032:analysis* / Q000235:genetics; D002845:Chromatography / Q000379:methods; D016360:Clostridioides difficile / Q000235:genetics / Q000302:isolation & purification* / Q000472:pathogenicity; D003601:Cytotoxicity Tests, Immunologic; D003967:Diarrhea / Q000382:microbiology*; D004761:Enterocolitis, Pseudomembranous / Q000382:microbiology; D004768:Enterotoxins / Q000032:analysis*; D005243:Feces / Q000382:microbiology; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D016133:Polymerase Chain Reaction / Q000379:methods*; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013997:Time Factors
chemical_list: D001426:Bacterial Proteins; D001427:Bacterial Toxins; D004768:Enterotoxins; D011933:Reagent Kits, Diagnostic; C041348:tcdA protein, Clostridium difficile; C031815:toxB protein, Clostridium difficile