Comparison between the 13C-urea breath test and stool antigen test for the diagnosis of childhood Helicobacter pylori infection

Abstract

As noninvasive tests for Helicobacter pylori infection, the 13C-urea breath test (UBT) and stool antigen test have been widely used. In children, however, there are few studies reporting which test shows superior performance. The purpose of this study was to compare the 13C-UBT and stool antigen test for their accuracy in diagnosing H. pylori infection in children. A total of 123 Japanese children, ages 2 to 17 years (mean, 12 years) who underwent gastric biopsies for H. pylori infection were studied. The diagnoses included gastritis (n = 55), gastric ulcer (n = 5), duodenal ulcer (n = 20), iron-deficiency anemia (n = 7), and other conditions (n = 36). The cutoff value of the 13C-UBT was defined to be 3.5 per thousand. The stool antigen test was performed using the HpSA enzyme-linked immunosorbent assay (ELISA) (Premier Platinum HpSA). In 16 patients who received eradication therapy, the 13C-UBT and HpSA were repeated 2 months after treatment. Based on biopsy tests, 60 children were infected with H. pylori and 63 children were not. For the 13C-UBT, the sensitivity, specificity, and accuracy were 95.0% (95% confidence interval [CI], 86.1%-99.0%), 98.4% (95% CI, 91.5%-100%), and 96.4% (95% CI, 93.6%-99.9%), respectively. For the HpSA, the sensitivity, specificity, and accuracy were 98.3% (95% CI, 90.8%-100%), 98.4% (95% CI, 91.2%-100%), and 98.3% (95% CI, 96.0%-100%), respectively. There were no significant differences between the performance of these two tests. In the assessment of H. pylori eradication, the results of 13C-UBT and HpSA agreed with those of biopsy tests. The 13C-UBT and the HpSA are equally accurate for the diagnosis of active H. pylori infection in Japanese children.