Prospective multicenter evaluation of a new immunoassay and real-time PCR for rapid diagnosis of Clostridium difficile-associated diarrhea in hospitalized patients

Renate J. Van Den Berg, Lesla S.Bruijnesteijn Van Coppenraet, Hendrik Jan Gerritsen, Hubert P. Endtz, Eric R. Van Der Vorm, Ed J. Kuijper

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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.

Original languageEnglish
Pages (from-to)5338-5340
Number of pages3
JournalJournal of Clinical Microbiology
Issue number10
Publication statusPublished - Oct 2005

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