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감염 검출을 위한 4 가지 Enzyme Immunoassay 법의 평가
엄희섭(Hee Sub Eom),김범수(Pum Soo Kim),이종욱(Jong Wook Lee),배수환(Soo Hwan Pai),이진우(Jin Woo Lee),최 원(Won Choi),이돈행(Don Haeng Lee),권계숙(Kye Sook Kwon),조현근(Hyeon Geun Cho),김형길(Hyung Gil Kim),신용운(Yong Woon Shin) 대한소화기학회 2001 대한소화기학회지 Vol.37 No.5
Background/Aims: Serologic methods for the diagnosis of Helicobacter pylori (H. pylori) infection are simple and inexpensive but have low sensitivity and specificity. We compared four different commercial kits commonly used in Korea for the diagnosis of H. pylori infection. Methods: Forty-one consecutive patients were involved in this study. They all underwent gastric endoscopy and biopsy. To detect H. pylori infection, the biopsy samples were analyzed by histology, culture, and CLO(TM) test and the results were used as a gold standard. We performed serologic tests including Bio-Rad GAP IgG, Radim H. pylori IgG, CLI H. pylori IgG ELISA, and Genedia H. pylori ELISA. The results were analyzed by receiver operating characteristic (ROC) curves. Results: In comparison with a predefined gold standard, the sensitivity of GAP(TM), Genedia(TM), Radim(TM), and Clarke(TM) was 60, 100, 88, and 68%, respectively. The specificity of the tests was 87.5, 81.3, 93.8 and 93.8%, respectively. The adjusted cut-off values using the ROC curves improved the performance of the tests. Conclusions: Four serologic test kits commonly used in Korea are not different in the diagnostic accuracy for the detection of H. pylori infection, but ROC analysis can enable us to reexamine the validity of the cut-off valuse indicated by the manufacturers. Therefore, to optimize accuracy, the diagnostic performances of various serologic kits should be evaluated locally. (Korean J Gastroenterol 2001;37:312-318)