Rapid detection of anti-Helicobacter pylori IgG in urine using immunochromatography

Background: Non-invasive methods to detect the presence of H. pylori infection continue to be refined. Aim: To evaluate a new 20-min immunochromatography method (RAPIRUN H. pylori Antibody) for the presence of anti-H. pylori IgG in urine. Methods: We used the C-13-urea breath test to establish H. pylori status. We evaluated the urine test among 104 subjects including 43 with H. pylori infection confirmed by repeatedly positive urea breath tests and 61 H. pylori-negative subjects with repeatedly negative urea breath tests. Forty-one of the 43 subjects with H. pylori infection had a positive rapid urine test with two false negative tests. There were two false positive tests among the 61 with repeatedly negative urea breath tests. The sensitivity, specificity, positive and negative predictive values for the rapid urine test were 95.3%, 96.7%. 95.3%, and 96.7%, respectively. The kit was easy to use and required no special equipment. Conclusions: The rapid immunochromatography method for determination of anti-H. pylori IgG proved to be reliable with excellent sensitivity and specificity and is likely to be useful for both clinical and epidemiological studies.