机构地区:[1]山东大学齐鲁医院检验科,山东济南250012 [2]青岛市市北区妇幼保健计划生育服务中心,山东青岛266032
出 处:《山东大学学报(医学版)》2016年第12期46-52,共7页Journal of Shandong University:Health Sciences
基 金:国家自然科学基金(81472025)
摘 要:目的评估以化学发光微粒子免疫分析法(CLIA)和酶联免疫吸附法(ELISA)检测胃蛋白酶原用于萎缩性胃炎和胃癌辅助诊断的价值,并探讨两种方法检测的一致性。方法采用CLIA和ELISA分别检测胃蛋白酶原(PG)在健康对照组(95例)、非萎缩性胃炎组(173例)、萎缩性胃炎组(407例)和胃癌组(135例)患者的表达,检测PGⅠ、PGⅡ水平,计算PGⅠ/PGⅡ的比值(PGR),分别建立两种方法诊断的cut-off值,评估其诊断价值,并分析两种方法检测的一致性。结果胃癌组PGⅡ高于萎缩性胃炎组、非萎缩性胃炎组和健康对照组(CLIA:P=0.027,0.002,<0.001;ELISA:P=0.008,<0.001,<0.001),PGR低于萎缩性胃炎组、非萎缩性胃炎组和健康对照组(CLIA:P<0.001,<0.001,<0.001;ELISA:P<0.001,<0.001,0.001)。CLIA法以PGⅡ>13.20且PGR≤6.67作为诊断胃癌的cut-off值,其敏感性和特异性为80.88%、71.64%;ELISA法以PGⅡ>18.10且PGR≤6.18作为诊断胃癌的cut-off值,其敏感性和特异性为80.14%、62.72%。两种方法诊断胃癌和萎缩性胃炎的一致性Kappa指数分别为0.706、0.569。结论 PGⅡ和PGR可以作为胃癌诊断标志物,PGⅡ+PGR联合诊断萎缩性胃炎和胃癌敏感性和特异性较高,且CLIA和ELISA两种方法检测结果一致性良好。Objective To evaluate the significance of pepsinogen in atrophic gastritis and gastric cancer using chemiluminesent immunoassay assay( CLIA) and enzyme linked immunosorbent assay( ELISA),and to analyze the consistency of the two methods. Methods CLIA and ELISA were used to determine the expressions of serum PG Ⅰ,PG Ⅱand PG Ⅰ / Ⅱ( PGR) in healthy controls( n = 95),non-atrophic gastritis cases( n = 173),atrophic gastritis cases( n = 407) and gastric cancer cases( n = 135). The most suitable cut-off values of PG of the two methods were determined. Their diagnostic efficiencies were evaluated,and the consistency of CLIA and ELISA in detecting PG was analyzed. Results The expression of PG Ⅱ in gastric cancer group was higher than in atrophic gastritis group,nonatrophic gastritis group,and healthy controls( CLIA: P = 0. 027,0. 002,〈 0. 001; ELISA: P = 0. 008, 〈0. 001, 〈0. 001). PGR in gastric cancer group was lower than in atrophic gastritis group,non-atrophic gastritis group,and healthy controls( CLIA: P〈0. 001, 〈0. 001, 〈0. 001; ELISA: P〈0. 001, 〈0. 001,0. 001). PG Ⅱ〉 13. 20 and PGR≤6. 67 were considered the most suitable cut-off value for diagnosing gastric cancer using CLIA,and the sensitivityand specificity were 80. 88% and 71. 64%,respectively. PG Ⅱ 18. 10 and PGR≤6. 18 were considered the most suitable cut-off value for diagnosing gastric cancer using ELISA,and the sensitivity and specificity were 80. 14% and 62. 72%,respectively. Further analysis showed that Kappa index of CLIA and ELISA in diagnosing gastric cancer and atrophic gastritis were 0. 706 and 0. 569,respectively. Conclusion PG Ⅱand PGR can be used as useful biomarkers for the diagnosis of gastric cancer. The combination of PG Ⅱ and PGR has considerable diagnostic value of atrophic gastritis and gastric cancer with higher sensitivity and specificity. CLIA and ELISA have a good consistency in detecting PG.
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