Journal
JOURNAL OF GASTROENTEROLOGY
Volume 39, Issue 7, Pages 621-628Publisher
SPRINGER TOKYO
DOI: 10.1007/s00535-004-1356-3
Keywords
Helicobacter pylori; C-13-urea breath test; C-13-urea; tablet
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Background. In Japan, urea breath-testing includes mouth rinsing with water immediately after the ingestion of C-13-urea solution, to prevent false-positive results that are caused by oral bacteria with urease activity. Our objective was to evaluate the diagnostic performance of a urea breath test using a film-coated C-13-urea tablet and omitting mouth rinsing. Methods. The study was a multicenter trial comparing the solution- and tablet-based urea breath tests (UBTs). Helicobacter pylori status was determined by histology, culture, and rapid urease testing. Results. Of the 255 subjects who completed the study, evaluation of the tablet-based UBT was possible in 254, and comparison of the tablet-based UBT and the solution-based UBT was possible in 250 patients. When the assessment achieved by a combination of biopsy-based methods was used as a reference standard, the sensitivity, specificity, and accuracy of the tablet-based method were determined to be 97.7%, 98.4%, and 98.0%, respectively. When the results of the solution-based UBT were used as a reference standard, the sensitivity, specificity, and accuracy of the tablet-based UBT were determined to be 96.9%, 97.6%, and 97.2%, respectively. Conclusions. The C-13-urea tablet-based method proved to be a simple and accurate test for the diagnosis of H. Pylori infection. Mouth rinsing was not required.
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