Comparative evaluation of urine-based and other minimally invasive methods for the diagnosis of Helicobacter pylori infection

Background: Diagnostic methods have recently been developed for detecting anti-Helicobacter pylori antibody in urine and H. pylori antigen in stool samples. Our aim was to evaluate the usefulness of noninvasive urine-based methods for the diagnosis of H. pylori infection. Methods: The study subjects were 100 asymptomatic Japanese volunteers. We investigated the diagnostic efficacy of various noninvasive diagnostic methods; five serological tests (Immunis anti-pylori, HM-CAP, EIAgen Helicobacter pylori IgG, Helico G, and GAP-IgG), one test for antigen in stool (HpSA enzyme immunoassay EIA]), and two tests for antibody in urine (Urinelisa and Rapirun) by using the urea breath test (UBT) as the gold standard. Results: Fifty subjects were diagnosed as positive for H. pylori infection by the UBT. The serological tests showed good sensitivity, specificity, and accuracy. The diagnostic values of the feces-based test (HpSA EIA) were lower than that of the serological tests. The sensitivities of the two urine-based methods in frozen urine samples were markedly lower than those of the other tests. However, the use of unfrozen samples markedly improved the diagnostic accuracy of these urine-based tests, which was then superior to that of the feces-based method. Conclusions: This study clearly showed that urine-based tests were useful for the diagnosis of H. pylori infection. However, the use of frozen urine samples was not appropriate for the detection of anti-H. pylori antibody. Received: November 5, 2001 / Accepted: February 22, 2002 Acknowledgments. We wish to thank Ms. Rika Tohma, Ms. Shiho Yamamoto, Ms. Yukiko Inoue, Mr. Masahiro Ishibashi, and Mr. Nobuo Sasaki for their technical supports. This work was supported in part by Grants-in-Aid for Scientific Research from the Ministry of Education, Science, and Culture of Japan. Reprint requests to: K. Adachi