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한국인에서 Helicobacter pylori 감염의 진단에 있어 Genedia™ H . pylori ELISA 검사의 진단 정확도
정인식(In Sik Chung),김상우(Sang Woo Kim),고재성(Jae Sung Go),김나영(Na Young Kim),김재규(Jae Gyu Kim),김진호(Jin Ho Kim),김학양(Hak Yang Kim),김재준(Jae Jun Kim),노임환(Im Hwan Roe),심재건(Jae Geon Sim),안형식(Hyeong Sik Ahn),윤병철(By 대한내과학회 2001 대한내과학회지 Vol.61 No.1
Background: Genedia™ 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 Genedia™ H. pylori ELISA for the diagnosis of H. pylori infection in Korean population. Methods Genedia : 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 Genedia™ H. pylori ELISA. H, pylori infection was determined by rapid urease test, histology, culture or (13)C-urea breath test in adults. In children, the subject was considered to he H. pylori positive if (13)C-urea breath test was positive. Results: In adults, the sensitivity and specificity of Genedia™ 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 Genedia™ H. pylori ELISA were 80%, 84.8%, 61.5%, and 93.3%. Sensitivity and negative predictive value of Genedia™ H. pylori ELISA were significantly higher than those of GAP-IgG (93.2% vs. 67.2%, p<0.005 and 92.5% vs 71.4%, p<0.005, respectively). Conclusion : Genedia™ 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 Genedia™ H. pylori ELISA for epidemiological studies of H. pylori infection in Korea. (Korean J Med 61:17-23, 2001)