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 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.
Cardenas
Victor M
VM
Division of Epidemiology, University of Texas School of Public Health, El Paso, TX 79902, USA. victor.cardenas@uth.tmc.edu
Dominguez
Delfina C
DC
Puentes
Flor A
FA
Aragaki
Corinne C
CC
Goodman
Karen J
KJ
Graham
David Y
DY
Fukuda
Yoshihiro
Y
D000942:Antigens, Bacterial / Q000032:analysis*; D001944:Breath Tests; D002247:Carbon Isotopes; D002374:Catalase / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D005243:Feces / Q000737:chemistry*; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis*; D016480:Helicobacter pylori / Q000201:enzymology / Q000276:immunology*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods; D007074:Immunoglobulin G / Q000097:blood; D007223:Infant; D008297:Male; D010865:Pilot Projects; D015995:Prevalence; D015203:Reproducibility of Results; D012189:Retrospective Studies; D012680:Sensitivity and Specificity
D000942:Antigens, Bacterial; D002247:Carbon Isotopes; D007074:Immunoglobulin G; D002374:Catalase