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

• Published in: The Korean journal of helicobacter and upper gastrointestinal research pp. 54 - 62
• Main Authors: 임선희, 김나영, 김성은, 백광호, 이주엽, 박경식, 신정은, 송현주, 명대성, 최석채, 김현진
• Format: Journal Article
• Language: Korean
• Published: 대한상부위장관ㆍ헬리코박터학회 01.03.2020
• Subjects: 내과학
• ISSN: 1738-3331; 2671-826X
• DOI: 10.7704/kjhugr.2019.0014

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®. KCI Citation Count: 1