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 [ 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 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.
This guideline updates a prior consensus recommendation of the German Society for Digestive and Metabolic Diseases (DGVS) from 1996. It was developed by an interdisciplinary cooperation with representatives of the German Society for Hygiene and Microbiology, the Society for Pediatric Gastroenterology and Nutrition (GPGE), and the German Society for Rheumatology. The guideline is methodologically based on recommendations of the Association of the Scientific Medical Societies in Germany (AWMF) for providing a systematic evidence-based S 3 level consensus guideline and has also implemented grading criteria according to the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) process. Clinical applicability of study results as well as specifics for Germany in terms of epidemiology, antibiotic resistance status, diagnostics, and therapy were taken into account.
Our study showed that children who have severe cerebral palsy (CP), with a gastrostomy and fundoplication, had significantly faster gastric emptying (GE) with wheybased enteral formulas (either 50% whey or 100% whey) compared to a casein-based formula. Five of the 13 children (39%) who had delayed GE with the casein formula, normalized with one of the whey-based formulas (using the age-related reference range). Standard practice for enteral feeding has historically involved the use of caseinbased enteral formulas. In the scenario of a child with CP and delayed GE, a trial of a whey-based enteral formula may be warranted.
A new rapid office-based one-step monoclonal immunoassay (RAPID Hp StAR, DakoCytomation, Cambridge, UK) for detection of Helicobacter pylori antigen in stool was evaluated in children against invasive diagnostic methods and compared to the results of a monoclonal EIA targeting the same antigen (Amplified IDEIA Hp StAR, DakoCytomation, Cambridge, UK). Coded stool samples from 118 symptomatic children (0.3-18.8 years) were investigated prior to any anti-H. pylori therapy. Fifty-four children were H. pylori infected defined by positive culture and/or two other positive tests ((13)C-urea breath test, histology, rapid urea test), the remaining 64 children showed concordant negative results. Thirty-four infected children (4.8-17.8 years) were monitored with (13)C-urea breath test (five remained positive) and stool test 6-8 weeks after anti-H. pylori therapy. The immunoassays were independently read by two investigators. The monoclonal EIA showed excellent sensitivity and specificity before (98% and 100%, respectively) and after therapy (100%; 96.2%). The rapid immunoassay was invalid for technical reasons in nine samples (5.9%). The two observers agreed in 31 positive and 93 negative results, but had discordant results in 17 samples (11.2%). Overall, the rapid test showed a poor sensitivity (63.8%-71.1%), but a good specificity (91.1%-96.2%) before treatment. We conclude that the new office based monoclonal enzyme immunoassay for diagnosis of H. pylori should be modified to improve sensitivity, inter-observer-variability and some technical problems. In contrast, the monoclonal EIA stool test is highly reliable, both pre- and post therapy, and equivalent to the (13)C-urea breath test.
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