ROC曲线对ELISA检测丙型肝炎抗体阳性判断值的确定和分析

摘要

目的：采用受试者工作特征（ROC ）曲线确定和分析2种不同酶免分析系统酶联免疫吸附试验（ELISA）检测丙型肝炎抗体（抗 HCV）的阳性判断值（Cut-off）。方法收集202份血清，用重组免疫印迹法（RIBA）确认抗HCV，同时采用国产addcare ELISA 1100全自动酶免分析系统（简称addcare ELISA 1100）和进口TECAN＋FAME组合的酶免分析系统（简称TECAN＋FAME酶免系统）检测抗HCV，对吸光度（A）值绘制ROC曲线，得出ELISA检测抗HCV在本实验室的最佳Cut-off值。结果以RIBA结果为金标准，ROC曲线分析结果显示，addcare ELISA 1100检测抗HCV的最佳Cut-off值为0．448，敏感性为99．3％，特异性为96．7％，约登指数为0．960，ROC曲线下面积为0．998，TECAN＋FAME酶免系统检测抗HCV的最佳Cut-off值为0．406，敏感性为99．3％，特异性为96．7％，约登指数为0．960，ROC曲线下面积为0．998。结论采用ROC曲线分析得到两种不同酶免分析系统ELISA检测抗HCV的Cut-off值分别为0．448和0．406，检测抗HCV的“灰区”分别设定为0．140～0．448和0．140～0．406，均可优化检测性能。%Objective To confirm and analyze the cut-off value in anti-hepatitis C virus (HCV ) antibody determined by 2 different kinds of enzyme-linked immunosorbent assay (ELISA)analysis systems with receiver operating characteristic (ROC)curve.Methods A total of 202 sera confirmed by recombinant immunoblot assay (RIBA)were determined by domestic addcare ELISA 1 100 automatic analysis system and imported combined TECAN with FAME ELISA analysis system for anti-HCV antibody.ROC curve was drawn with absorbance (A)by SPSS 17.0 software,and the optimal cut-off value was obtained.Results According to the results of ROC curve,RIBA as the golden standard, the optimal cut-off values were 0.448 in addcare ELISA 1 100 automatic analysis system and 0.406 in TECAN+FAME combined ELISA analysis system.Their sensitivities,specificities,Youden indices and areas under ROC curve were 99.3%,99.3%;96.7%,96.7%;0.960,0.960 and 0.998,0.998.Conclusions The cut-off values are 0.448 and 0.406 in the 2 analysis systems with by ROC curve,and the ambiguous regions are 0.140-0.448 and 0.140-0.406. The 2 ELISA analysis systems can optimize the performance of detection.