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헬리코박터 파일로리균 감염에 대한 IMMULITE2000®의 GENEDIA®와의 정확성 비교

A Comparison of Accuracy between IMMULITE2000® and GENEDIA® for Helicobacter pylori Infection

임선희 ( Lim Seon-Hee ) - 서울대학교병원 헬스케어시스템 강남센터

김나영 ( Kim Na-Young ) - 분당서울대학교병원 내과
김성은 ( Kim Sung-Eun ) - 고신대학교 의과대학 내과학교실
백광호 ( Baik Gwang-Ho ) - 한림대학교 의과대학 내과학교실
이주엽 ( Lee Ju-Yup ) - 계명대학교 의과대학 내과학교실
박경식 ( Park Kyung-Sik ) - 계명대학교 의과대학 내과학교실
신정은 ( Shin Jeong-Eun ) - 단국대학교 의과대학 내과학교실
송현주 ( Song Hyun-Joo ) - 제주대학교 의학전문대학원 내과학교실
명대성 ( Myung Dae-Sung ) - 전남대학교 의과대학 내과학교실
최석채 ( Choi Suck-Chei ) - 원광대학교 의과대학 내과학교실
김현진 ( Kim Hyun-Jin ) - 경상대학교 의과대학 내과학교실

Abstract


Background/Aims: In serological tests for Helicobacter pylori (H. pylori), an enzyme-linked immunosorbent assay (GENEDIA®) and a solid-phase, two-step chemiluminescent enzyme immunoassay (IMMULITE®), which are easy to perform, inexpensive, and widely available, are commonly used. However, local validation of the test performance of IMMULITE® is required. This study aimed to examine the performance of IMMULITE® in comparison with that of GENEDIA® in a Korean health checkup population.

Materials and Methods: The sera of 300 subjects among those who underwent health checkup were analyzed using IMMULITE®, and results were compared with those of GENEDIA®. 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® and IMMULITE®. The area under the receiver operating characteristics curve (AUC) for AG using GENEDIA® and IMMULITE® 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® and IMMULITE® 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® and IMMULITE®.

키워드

Enzyme-linked immunosorbent assay; Helicobacter pylori; Immunoenzyme techniques; Serology
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