Recently, Helicobacter pylori (H. pylori) has been reported that it is involved in the pathogenesis of duodenal ulcer and might be a risk factor for gastric cancer. To diagnose H. pylori infection, detection of serum antibody is much less stressful and more cost effective than gastric biopsy. Using a serological method, We have reported that the prevalence of serum anti-H. pylori IgG was elevated with age among healthy subjects and over 80% among elder people. Thus, it would be essential to investigate the specificity of the ELISA system (PirikaplateG Helicobacter) for the detection of serum anti-H. pylori IgG. Sera from healthy controls (n = 653) and patients (n = 116) with gastritis, gastric ulcer, and/or duodenal ulcer were studied for anti-H. pylori IgG. Cross reactivity of the anti-H. pylori IgG with closely related bacteria was less than 10% (with C. jejuni: 7.4%, C. laridis: 0.2%, E. coli: -2.4%) in the ELISA system. Anti-H. pylori IgG from both normal controls and the patients were equally neutralized with the extract of H. pylori. Of note was that the prevalence of anti-H. pylori IgG among patients was significantly higher than that among normal controls. Referring to the diagnoses by gastric biopsy, the sensitivity and specificity of this ELISA were 88.2% and 74.2%, respectively. We also demonstrated the clinical usefulness of this ELISA by receiver operating characteristic curve (ROC). Interestingly, several healthy subjects positive for serum anti-H. pylori IgG were voluntarily subjected to gastric biopsy, and proved positive for H. pylori infection.(ABSTRACT TRUNCATED AT 250 WORDS)