A new rapid test for detecting anti-Helicobacter pylori antibody excreted into urine

Abstract

Background: Helicobacter pylori infection has been one of the most common infectious diseases in the world, whereas a gold standard for identifying its infection has not yet been established. The specific test will depend on the particular clinical, epidemiological, and scientific requirements. We recently developed a new type of rapid test to detect H. pylori antibody excreted into urine; the test requires only 20 minutes. The purpose of this study was to examine the accuracy of this rapid test.

Methods: The performance of the rapid test was compared with those of a histological search through Giemsa staining and of an assay for detecting antibodies in serum by a commercially available ELISA kit. The patients, totaling 117 (male, 62, female, 55; average age, 51.6 years), included those with peptic ulcer endoscopically diagnosed and excluded cases that were subjected to eradication therapy in the past.

Results: With respect to the determinations of H. pylori identified by the microscopical test and the serum antibody assay, our kit had a sensitivity of 92. 0% and a specificity of 93.1%, and the agreement of determination of H. pylori infection was as high as 91.5% and 92.3%, respectively.

Conclusions: The rapid test for antibodies to H. pylori in urine could detect H. pylori infection easily, rapidly, and noninvasively and would be useful in general practice for screening patients with dyspeptic symptoms.