A rapid immunochromatographic assay for Helicobacter pylori in stool before and after treatment.

Background: Current guidelines recommend non-invasive testing and treatment of young dyspeptic patients without alarm symptoms. Aim: To evaluate the accuracy of a new rapid immunochromatographic stool test to diagnose Helicobacter pylori infection before and after treatment compared with a gold standard. Methods: Prospective, single-blind study, performed in a tertiary care hospital. A total of 303 consecutive dyspeptic patients underwent endoscopy with multiple biopsies. Infected patients were offered a treatment and invited to come back 4-6 weeks after the end of therapy to repeat the endoscopy. Patients were also asked to provide a stool sample before and after therapy. Results: About 149 patients were H. pylori infected. The sensitivity and specificity before treatment were 91.3 and 93.5%; after treatment 92 and 100%. The likelihood ratios were robust enough to produce significant changes from pretest to post-test probability both in pre-treatment (LR+ = 14, LR- = 0.093) and post-treatment (LR+ = 19.6, LR- = 0.095). Conclusions: The novel immunochromatographic stool test is fast, easy to perform and provides good differentiation between positive and negative results. It might become a rapid near patients test easily performed in the doctor office.