KMID : 0931320200200010054
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´ëÇÑ»óºÎÀ§Àå°ü.Ç︮ÄÚ¹ÚÅÍÇÐȸÁö 2020 Volume.20 No. 1 p.54 ~ p.62
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A Comparison of Accuracy between IMMULITE2000¢ç and GENEDIA¢ç for Helicobacter pylori Infection
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Lim Seon-Hee
Kim Na-Young Kim Sung-Eun Baik Gwang-Ho Lee Ju-Yup Park Kyung-Sik Shin Jeong-Eun Song Hyun-Joo Myung Dae-Sung Choi Suck-Chei Kim Hyun-Jin
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Abstract
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Background/Aims: In serological tests for Helicobacter pylori (H. pylori), an enzyme-linked immunosorbent assay (GENEDIA¢ç) and a solid-phase, two-step chemiluminescent enzyme immunoassay (IMMULITE¢ç), which are easy to perform, inexpensive, and widely available, are commonly used. However, local validation of the test performance of IMMULITE¢ç is required. This study aimed to examine the performance of IMMULITE¢ç in comparison with that of GENEDIA¢ç in a Korean health checkup population.
Materials and Methods: The sera of 300 subjects among those who underwent health checkup were analyzed using IMMULITE¢ç, and results were compared with those of GENEDIA¢ç. The two serological tests were compared for their ability to predict atrophic gastritis (AG) or intestinal metaplasia (IM) on endoscopy.
Results: We found significant correlation (Pearson correlation coefficient=0.903, P<0.0001) and an almost perfect agreement (Cohen¡¯s Kappa coefficient=0.987, P<0.0001) between the results of GENEDIA¢ç and IMMULITE¢ç. The area under the receiver operating characteristics curve (AUC) for AG using GENEDIA¢ç and IMMULITE¢ç were 0.590 and 0.604, respectively, and showed no statistically significant difference in predictive ability for AG (Z-statistics=-0.517, P=0.605). The AUC for IM by GENEDIA¢ç and IMMULITE¢ç were 0.578 and 0.593, respectively, with no statistically significant difference in predictive ability for IM between the two values (Z-statistics=-0.398, P=0.691).
Conclusions: No statistically significant difference in diagnostic value for H. pylori infection was found between GENEDIA¢ç and IMMULITE¢ç.
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KEYWORD
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Enzyme-linked immunosorbent assay, Helicobacter pylori, Immunoenzyme techniques, Serology
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