Accuracy of GenediaTM H. pylori ELISA for the Diagnosis of Helicobacter pylori Infection in Korean Population / 대한내과학회지

ABSTRACT

BACKGROUND: GenediaTM H. pylori ELISA is a newly developed diagnostic method which detects serum anti-H. pylori IgG antibody. The aim of this study was to assess the accuracy of GenediaTM H. pylori ELISA for the diagnosis of H. pylori infection in Korean population. METHODS: GenediaTM H. pylori ELISA and GAP-IgG were performed in 353 adult sera and Pyloriset-IgG EIA in 184 subjects. In children, 43 serum samples were tested with GenediaTM H. pylori ELISA. H. pylori infection was determined by rapid urease test, histology, culture or 13C-urea breath test in adults. In children, the subject was considered to be H. pylori positive if 13C-urea breath test was positive. RESULTS: In adults, the sensitivity and specificity of GenediaTM H. pylori ELISA were 93.2% and 83.5% with positive and negative predictive values of 85.1% and 92.5%. Those for GAP-IgG and Pyloriset-IgG EIA were 67.2%, 82.4%, 79.3%, 71.4% and 89.1%, 88.4%, 71.9%, 96.1%, respectively. In children, sensitivity, specificity, positive and negative predictive values of GenediaTM H. pylori ELISA were 80%, 84.8%, 61.5%, and 93.3%. Sensitivity and negative predictive value of GenediaTM H. pylori ELISA were significantly higher than those of GAP-IgG (93.2% vs. 67.2%; plt;0.005 and 92.5% vs 71.4%; p<0.005, respectively). CONCLUSION: GenediaTM H. pylori ELISA is a relatively accurate method for the serodiagnosis of H. pylori infection in Korean subjects compared to GAP-IgG. These results may suggest the clinical use of GenediaTM H. pylori ELISA for epidemiological studies of H. pylori infection in Korea.