Immunochromatographic monoclonal test for detection of Helicobacter pylori antigen in stool is useful in children from high-prevalence developing country

Background: Tests to detect Helicobacter pylori antigens in feces for diagnosis of infection in children demonstrate controversial results. one novel and fast monoclonal test improves diagnostic accuracy in adults, but clinical evidence of its usefulness at pediatric age is insufficient to date. The objective of this work was to evaluate the diagnostic accuracy of this test in a sample of Mexican children. Methods: We conduced a transversal study in 150 selected children with digestive symptoms suggestive of organic disease in whom a clinical history was conducted in addition to a fast monoclonal test (immunoCardSTATO (R) HpSA, Meridian Diagnostics) performed by immunchromatography. Patients were submitted to endoscopy and histopathologic study. Results: Of the 150 children (mean age 7.8 +/- 4.7 years), 107 (71.3%) were positive for the test, and presence of H. pylori was confirmed histologically in 109 (72.7%) children, with sensitivity of 96.3% (95% CI = 95.8-96.8), specificity of 95.1% (95% CI = 93.9-96.4), and accuracy of 96.0% (95% CI, -95.6 to -96.3); pretest probability was 0.73, while post-test probability was 0.98. Infection rate and test accuracy increased with age. Conclusions: This test is useful for detecting H. pylori infection in children of all ages, and is a good alternative for screening studies in developing countries with elevated prevalence due to its being fast, noninvasive, inexpensive, and easy to carry out.