Choi Yonghoon, Kim Nayoung, Lim Seon Hee, Park Ji Hyun, Lee Jeong Hwan, Kim Yeejin, Jo Hyemin, Lee Ho-Kyoung, Choi Jinju, Jun Yu Kyung, Yoon Hyuk, Shin Cheol Min, Park Young Soo, Lee Dong Ho
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Research Center for Sex- and Gender-Specific Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
J Cancer Prev. 2024 Dec 30;29(4):148-156. doi: 10.15430/JCP.24.024.
Serological tests for needs local validation as the diagnostic accuracy may vary depending on the prevalence of . . This study examined the diagnostic performance of two ELISA, GastroPanel (GastroPanel ELISA; Biohit Oyj) and GENEDIA (GENEDIA . ELISA, Green Cross Co.) in Korean population. One thousand seventy seven patients who visited for esophagogastroduodenoscopy between 2013 and 2023 were prospectively enrolled, and serum samples from the subjects were tested using both GastroPanel and GENEDIA. The two tests were compared for their diagnostic accuracy in detecting atrophic gastritis (AG), intestinal metaplasia (IM), gastric adenoma (GA), and gastric cancer (GC), and the positivity rates by age and sex were observed. There was substantial correlation (Pearson coefficient [r] = 0.512, < 0.001) and agreement (Cohen's Kappa coefficient [κ] = 0.723, < 0.001) between the results obtained using GastroPanel and GENEDIA. The test results from the two kits did not match perfectly with a discrepancy observed in approximately 16% of cases, that 67 subjects were positive only on GENEDIA while 75 subjects were positive only on GastroPanel. The area under receiver operating characteristic curve for AG, IM, GA, and GC using GastroPanel were 0.666, 0.635, 0.540, and 0.575, while the results tested using GENEDIA were 0.649, 0.604, 0.553, and 0.555, respectively, without significant difference between the two results. GastroPanel and GENEDIA showed similar performance in terms of diagnostic accuracy; but the test results did not match perfectly. A large-scale validation study in Koreans is needed.
血清学检测需要进行本地验证，因为诊断准确性可能会因……的流行率而异。本研究考察了两种酶联免疫吸附测定法（ELISA），即胃肠功能检测板（GastroPanel ELISA；芬兰百得公司）和杰内迪亚检测法（GENEDIA ELISA，韩国绿十字公司）在韩国人群中的诊断性能。前瞻性纳入了2013年至2023年间因食管胃十二指肠镜检查前来就诊的1077例患者，并使用胃肠功能检测板和杰内迪亚检测法对受试者的血清样本进行检测。比较了这两种检测方法在检测萎缩性胃炎（AG）、肠化生（IM）、胃腺瘤（GA）和胃癌（GC）方面的诊断准确性，并观察了按年龄和性别划分的阳性率。使用胃肠功能检测板和杰内迪亚检测法获得的结果之间存在显著相关性（皮尔逊系数[r]=0.512，P<0.001）和一致性（科恩卡方系数[κ]=0.723，P<0.001）。两种试剂盒的检测结果并不完全匹配，约16%的病例存在差异，即67例受试者仅杰内迪亚检测法呈阳性，而75例受试者仅胃肠功能检测板呈阳性。使用胃肠功能检测板检测AG、IM、GA和GC的受试者工作特征曲线下面积分别为0.666、0.635、0.540和0.575，而使用杰内迪亚检测法检测的结果分别为0.649、0.604、0.553和0.555，两者结果之间无显著差异。胃肠功能检测板和杰内迪亚检测法在诊断准确性方面表现相似；但检测结果并不完全匹配。需要在韩国人群中开展大规模验证研究。
