Evaluation of a urine antibody test for Helicobacter pylori in Japanese children

J Pediatr. 2004 Feb;144(2):196-9. doi: 10.1016/j.jpeds.2003.10.057.


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.

Publication types

  • Comparative Study
  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Antibodies, Bacterial / urine*
  • Antigens, Bacterial / analysis
  • Breath Tests
  • Child
  • Child, Preschool
  • Enzyme-Linked Immunosorbent Assay / methods*
  • False Negative Reactions
  • False Positive Reactions
  • Feces / microbiology
  • Female
  • Helicobacter Infections / diagnosis*
  • Helicobacter pylori / immunology*
  • Humans
  • Immunoglobulin G / immunology
  • Immunoglobulin G / urine*
  • Japan
  • Male
  • Sensitivity and Specificity
  • Urea


  • Antibodies, Bacterial
  • Antigens, Bacterial
  • Immunoglobulin G
  • Urea