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Journal of Clinical Microbiology, October 2005, p. 5338-5340, Vol. 43, No. 10
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.10.5338-5340.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

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,1 Lesla S. Bruijnesteijn van Coppenraet,1 Hendrik-Jan Gerritsen,1 Hubert P. Endtz,2 Eric R. van der Vorm,3 and Ed J. Kuijper1*

Department of Medical Microbiology, Center of Infectious Diseases, Leiden University Medical Center, Leiden,1 Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center, Rotterdam,2 Department of Medical Microbiology, VU University Medical Center, Amsterdam, The Netherlands3

Received 1 April 2005/ Returned for modification 19 May 2005/ Accepted 8 July 2005

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.

* Corresponding author. Mailing address: Department of Medical Microbiology, E4-67, Center of Infectious Diseases, P.O. Box 9600, 2300 RC Leiden, The Netherlands. Phone: 31-71-5263931. Fax: 31-71-5248148. E-mail: e.j.kuijper{at}lumc.nl.

Journal of Clinical Microbiology, October 2005, p. 5338-5340, Vol. 43, No. 10
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.10.5338-5340.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.



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