Open AccessEvaluation 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
Author(s) -
Christian Lottspeich,
A. Schwarzer,
Klaus Panthel,
Sibylle Koletzko,
Holger Rüssmann
Publication year - 2007
Publication title -
journal of clinical microbiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.349
H-Index - 255
eISSN - 1070-633X
pISSN - 0095-1137
DOI - 10.1128/jcm.00103-07
Subject(s) - helicobacter pylori , clarithromycin , etest , immunoassay , gold standard (test) , breath test , spirillaceae , antigen , feces , biology , helicobacter infections , polymerase chain reaction , microbiology and biotechnology , medicine , gastroenterology , gastritis , antibody , immunology , antibiotics , gene , biochemistry
The aim of the present study was to evaluate theHelicobacter pylori ClariRes assay (Ingenetix, Vienna, Austria) for the detection ofH. pylori infection and the simultaneous clarithromycin susceptibility testing of theH. 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 [13 C]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 positiveH. pylori status, 29 were found to be positive by real-time PCR (sensitivity, 63%). For these 29 cases, theH. pylori ClariRes assay confirmed all results from phenotypic clarithromycin susceptibility testing by Etest. In summary, this investigation demonstrates that detection ofHelicobacter 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 ofH. pylori infection in children.