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Journal of Clinical Microbiology, June 2007, p. 1718-1722, Vol. 45, No. 6
0095-1137/07/$08.00+0     doi:10.1128/JCM.00103-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.

Evaluation of the Novel Helicobacter pylori ClariRes Real-Time PCR Assay for Detection and Clarithromycin Susceptibility Testing of H. pylori in Stool Specimens from Symptomatic Children{triangledown}

Christian Lottspeich,1 Andrea Schwarzer,2 Klaus Panthel,1 Sibylle Koletzko,2 and Holger Rüssmann1*

Max von Pettenkofer-Institut für Hygiene und Medizinische Mikrobiologie,1 Dr. v. Haunersches Kinderspital, Ludwig-Maximilians-Universität München, Munich, Germany2

Received 15 January 2007/ Returned for modification 2 March 2007/ Accepted 18 March 2007

The aim of the present study was to evaluate the Helicobacter pylori ClariRes assay (Ingenetix, Vienna, Austria) for the detection of H. pylori infection and the simultaneous clarithromycin susceptibility testing of the H. pylori isolates in stool samples from 100 symptomatic children. The results obtained by this novel biprobe real-time PCR method were directly compared with the results obtained from histological examination of gastric biopsy specimens, culturing, the [13C]urea breath test, and a monoclonal antibody-based stool antigen enzyme immunoassay (EIA). Fecal specimens from all 54 children who were shown to be noninfected by "gold standard" tests gave true-negative PCR results (specificity, 100%). Of the remaining 46 individuals with a positive H. pylori status, 29 were found to be positive by real-time PCR (sensitivity, 63%). For these 29 cases, the H. pylori ClariRes assay confirmed all results from phenotypic clarithromycin susceptibility testing by Etest. In summary, this investigation demonstrates that detection of Helicobacter DNA in stool samples by real-time PCR is a difficult task and that this method cannot replace the stool antigen EIA (sensitivity, 95.7%) for the accurate diagnosis of H. pylori infection in children.

* Corresponding author. Mailing address: Max von Pettenkofer-Institute, Ludwig-Maximilians-University, Pettenkoferstr. 9a, 80336 Munich, Germany. Phone: 0049-89-51605280. Fax: 0049-89-51605223. E-mail: ruessmann{at}mvp.uni-muenchen.de

{triangledown} Published ahead of print on 28 March 2007.

Journal of Clinical Microbiology, June 2007, p. 1718-1722, Vol. 45, No. 6
0095-1137/07/$08.00+0     doi:10.1128/JCM.00103-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.



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