Evaluation of a novel stool native catalase antigen test for Helicobacter pylori infection in asymptomatic North American children

J Pediatr Gastroenterol Nutr. 2008 Apr;46(4):399-402. doi: 10.1097/MPG.0b013e318148b688.

Abstract

Rapid immunochromatographic tests for Helicobacter pylori infection have been developed to allow "near-patient" testing. We therefore performed a pilot study to test a rapid immunochromatographic stool antigen test for the diagnosis of H. pylori infection in asymptomatic children. We tested stool specimens collected from children participating in a cohort study in the United States and Mexico. H. pylori-positive status was defined by positivity on at least 2 tests: a commercial H. pylori stool antigen enzyme immunoassay, an immunoglobulin G antibody enzyme immunoassay, and the C-urea breath test. Negative H. pylori status was defined by negative findings of all of these tests. Of 52 children (22 girls, 30 boys) 25 were H. pylori-positive, 19 H. pylori-negative, and 8 uncertain (eg, presumably negative; positive findings on 1 of the 3 noninvasive tests). The sensitivity and specificity of the new stool antigen test for those with definite H. pylori status were 100% (exact 95% CI 86.3%-100% and 82.4%-100%, respectively). This rapid stool antigen test may prove useful for point-of-care testing and epidemiological field studies. Larger prospective studies are needed in symptomatic and asymptomatic children for more precise estimates.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Antigens, Bacterial / analysis*
  • Breath Tests
  • Carbon Isotopes
  • Catalase / immunology
  • Child
  • Child, Preschool
  • Cohort Studies
  • Enzyme-Linked Immunosorbent Assay / methods
  • Feces / chemistry*
  • Female
  • Helicobacter Infections / diagnosis*
  • Helicobacter pylori / enzymology
  • Helicobacter pylori / immunology*
  • Humans
  • Immunoenzyme Techniques / methods
  • Immunoglobulin G / blood
  • Infant
  • Male
  • Pilot Projects
  • Prevalence
  • Reproducibility of Results
  • Retrospective Studies
  • Sensitivity and Specificity

Substances

  • Antigens, Bacterial
  • Carbon Isotopes
  • Immunoglobulin G
  • Catalase