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

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 inummo-chromatographic 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 iminunoglobulin G antibody enzyme immunoassay, and the C-13-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.