应用ROC曲线分析确定ELISA检测抗-HBe灰区

目的应用受试者工作特征曲线（ROC曲线）分析方法确定酶联免疫吸附试验（ELISA）检测乙型肝炎e抗体（抗-HBe）的灰区,为临床判读提供合理的指导。方法 ELISA检测血清抗-HBe,留取S/CO介于0.5～1.7的标本,用美国雅培Axsym化学发光仪对其复检,结合临床症状及乙型肝炎病毒标志物定量结果,筛选结果可靠的标本,进行ROC曲线分析,根据ROC曲线分别确定其灰区的上、下限。结果根据ROC曲线分析法计算得出检测灰区为0.827～1.576。结论 ROC曲线法是设定ELISA检测灰区的较理想方法,非灰区部分具备较低的假阳性率及假阴性率,能增加不同医院间结果的可比性,减少不必要的医疗纠纷。

Determination of grey zone of HBeAb tested by ELISA using ROC curve analysis

Objective To determine the grey zone of HBeAb tested by the ELISA method using receiver operating characteristic（ROC） curve analysis to provide rational guidance for clinical interpretation.Methods The ELISA method was adopted to test serum HBeAb.The serum samples with the S/CO range of 0.5-1.7 were collected and retested by the Abbott Axsym chemiluminescence apparatus.Combined the clinical symptoms and the quantitative results of hepatitis B viral markers,the samples with reliable results were screened and the ROC curve analysis was performed.According to the ROC curve,the upper and lower limits of the grey zone were determined.Results According to the ROC curve analysis,the grey zone of ELISA method was between 0.827-1.576.Conclusion The ROC curve analysis is an ideal method to calculate the grey zone of ELISA method,the non-grey zone part has the lower false positive and false negative rate,which can increase the comparability among the results from different hospitals and reduce unnecessary medical disputes.