Evaluation of a novel stool native catalase antigen test for Helicobacter pylori infection in asymptomatic North American children
Journal of Pediatric Gastroenterology and Nutrition
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. © 2008 Lippincott Williams & Wilkins, Inc.