JCM Accepts, published online ahead of print on 21 October 2009

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J. Clin. Microbiol. doi:10.1128/JCM.01204-09
Copyright (c) 2009, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

Improved performance of a rapid office based stool test for detection of Helicobacter pylori in children before and after therapy

C. Prell, S. Osterrieder, C. Lottspeich, A. Schwarzer, H. Rüssmann, G. Ossiander, and S. Koletzko^*

Dr. von Haunersches Kinderspital, Ludwig-Maximilians-University Munich, Lindwurmstraße 4, 80337 Munich, Germany; Max von Pettenkofer Institute for Hygiene and Medical Microbiology, Ludwig-Maximilians-University Munich, Pettenkoferstraße 9a, 80336 Munich, Germany; HELIOS Klinikum Emil von Behring, Institute for Microbiology, Immunology and Laboratory Medicine, Walterhöferstraße 11, 14165 Berlin, Germany

^* To whom correspondence should be addressed. Email: sibylle.koletzko{at}med.uni-muenchen.de.

A modified version of a rapid office based one-step monoclonal immunoassay for detection of Helicobacter pylori antigen in stool from children was evaluated against biopsy based methods and compared to a monoclonal enzyme immunoassay using the same antigen. Blinded stool samples from 185 children (0.3-18.2 years) were investigated at the time of upper endoscopy prior to anti-H. pylori therapy, 62 children were H. pylori infected and 123 non-infected according to predefined reference standards. Samples obtained 6 – 8 weeks after anti-H. pylori therapy were available from 58 children (3.8-17.7 years) and compared to results of the ¹³C-urea breath test (14/58 positive). The rapid stool tests were performed by two independent readers. Of 243 rapid tests performed, 1 (0.4%) was invalid for technical reasons. Equivocal results (very weak line) were reported 16 times by Reader 1, and 27 times by Reader 2. When equivocal results were considered as positive, the two observers agreed in 76 positive and 160 negative results, and disagreed in 7 samples (2.9%). The sensitivity was 90.8% for Reader 1 and 85.5% for Reader 2, the specificity 91.0% and 93.4%, respectively. The monoclonal enzyme immunoassay revealed a sensitivity and specificity of 94.7% and 97.6%, respectively.

The modified chromatographic immunoassay is a good alternative in settings or situations when the monoclonal enzyme immunoassay or the ¹³C-urea breath test are not available or feasible. In order to improve sensitivity, very weak lines should be considered as positive test results.