ABSTRACT
OBJECTIVE: To evaluate the accuracy of a urine-based enzyme-linked immunosorbent assay (ELISA) kit for anti-Helicobacter pylori immunoglobulin G antibody (urine-HpELISA) in children, we compared its sensitivity and specificity in reference to (13)C-urea-breath test (UBT) and H pylori stool antigen test (HpSA). STUDY DESIGN: Japanese children without significant upper abdominal symptoms were included (n=100; mean age, 7.0 years; range, 2 to 15). UBT, HpSA, and urine-HpELISA were performed. RESULTS: Of 100 children, 36 and 64 were judged H pylori-positive and H pylori-negative, respectively, by UBT and HpSA. Thirty-four of 36 positive children were positive by urine-HpELISA, and 62 out of 64 negative children were negative by urine-HpELISA. Thus, the urine-HpELISA had 94.4% sensitivity and 96.9% specificity, with accuracy of 96.0%. CONCLUSIONS: The urine-HpELISA is a rapid, inexpensive, reliable, and easy-to-perform method for the diagnosis of H pylori infection in children. It may be useful not only for diagnosis but also for mass screening for epidemiological studies in pediatric population.