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Appropriate cut-off value of 13C-urea breath test after eradication of Helicobacter pylori infection in Japan


Dr Toshiro Sugiyama, Department of Gastroenterology, Hokkaido University Graduate School of Medicine, Kita-15, Nishi-7, Sapporo, Japan. Email:


Background and Aim:  A cut-off value of 2.5‰ for the 13C-urea breath test (UBT) is recommended in Japanese persons, based on the result of a multicenter trial in patients prior to treatment for eradication of Helicobacter pylori. The cut-off value of 2.5‰ has also been used in the assessment of eradication after treatment. The 6–8-week evaluation after treatment is recommended in the guidelines of the Japanese Society of Gastroenterology. The present study aimed to prospectively re-assess the cut-off value of the 13C-UBT at 6 weeks after treatment by using the results obtained at 6 months as an indication of true positive or true negative H. pylori infection status.

Methods:  One hundred and ninety patients who were positive for H. pylori underwent eradication treatment, and 177 patients of these patients who were assessed as having true positive or true negative H. pylori status  at  6 months  after  treatment  were  evaluated  in  this  study.  Eradication  was  assessed  by 13C-UBT,  culture,  and  histology  at  6 weeks  and  at  6 months  after  treatment,  and  the  cut-off  value  of 13C-UBT at 6 weeks was re-assessed.

Results:  A cut-off value of 3.5‰. at 6 weeks after treatment showed 97.2% diagnostic accuracy, while a cut-off value of 2.5‰ at 6 weeks showed 96.0% diagnostic accuracy. For a 3.5‰ cut-off value, only five patients were positive by 13C-UBT and were negative by culture and histology at 6 weeks, and three patients were true positive and two were false positive by the 13C-UBT at 6 months.

Conclusion:  A cut-off value of 3.5‰ for the 13C-UBT is recommended at 6 weeks after eradication treatment in Japanese persons.