Comparison between a rapid office-based and ELISA serologic test in screening for Helicobacter pylori in children.

Background: The rapid diagnostic serological test for detection of Helicobacter pylori (H. pylori) infection in children has a significant advantage over the standard enzyme immunoassay (EIA) method, for its simplicity and rapid availability of results in a physician's office setting. We compared the immunochromatographic test with a standard enzyme immunoassay test in the pediatric population.

Materials And Methods: A retrospective analysis of 1147 serum samples from asymptomatic children and prospective analysis of 62 serum samples from symptomatic children undergoing diagnostic upper endoscopy were evaluated for the detection of H. pylori antibody by two commercially available serology tests. Each serum sample was tested by a rapid test (FlexSure HP, SmithKline Diagnostics, Inc.) and compared to the standard EIA method (HM-CAP, Enteric Products, Inc.).

Results: The rapid test, FlexSure HP, was comparable to the rapid EIA test in screening for H. pylori infection in symptomatic and asymptomatic children with sensitivity and specificity of 83-90% and 90-100%, respectively. Both methods had a comparable sensitivity and specificity for the detection of H. pylori-associated gastritis (60-70% and 94%, respectively).

Conclusion: The rapid test is comparable to the standard EIA test and may be used by physicians in symptomatic children. The use of FlexSure HP as a screening tool for the prevalence of H. pylori infection in asymptomatic children may be limited by its low positive predictive value compared to the EIA method.