五种D-二聚体检测方法用于排除可疑静脉血栓栓塞症的临床评价

Evaluation of Five D-dimer Assays for the Exclusion of Venous Thromboembolism

目的评价5种D-二聚体(D-di mer,DD)检测方法在排除疑似静脉血栓栓塞症(VTE)中的价值。方法采用传统酶联免疫吸附法(ELISA)、快速ELISA法(VIDAS DD)、光电散射免疫比浊法(DD Plus)、免疫比浊法(Liatest STAGO DD)、胶体金免疫渗透法(NycoCard DD),检测75例临床疑似VTE患者血浆DD含量,其结果与疾病诊断的金标准进行比较,以评价各种方法的特点、相关性及诊断效能。结果Liatest STAGO DD、DD Plus,VIDAS DD、传统ELISA DD检测都显示出良好的诊断效能(AUC均大于0.7),其中Liatest STAGO DD的敏感性(96.7%)和阴性预测值(95.5%)最高,AUC(0.814)最大,对排除VTE的诊断效能最大。传统ELISA法的特异性最高,为48.9%。各方法间有明显的相关性,其中VIDAS DD与Liatest STAGO DD相关性最好(r=0.9106),与传统ELISA方法相关性比较表明Liatest STAGO DD和VIDAS DD与传统ELISA方法相关性较好,r分别为0.8360和0.8764。结论Liatest STAGO DD、DD Plus、VIDAS DD检测快速简便,适用于单个样本的检测,有良好的诊断效能,有望取代传统ELISA法用于临床;临床应结合自身实际情况选择DD检测方法并确定其用于排除VTE的临界值。

Objective To evaluate the diagnostic performance of five D-dimer assays for the exclusion of suspected venous thromboembolis（VTE）.Methods The plasma D-dimer levels of 75 suspected VTE patients were tested with ELISA,VIDAS DD,DD Plus,Liatest STAGO DD,and NycoCard DD.The results of the five assays were compared with the gold standard of diagnosis of VTE.Results Liatest STAGO DD,DD Plus,VIDAS DD and ELISA had good diagnostic performance for the exclusion of suspected VTE.Liatest STAGO DD had the greatest accuracy for differentiating diagnosis,with 0.814 of area under the curve（AUC）,96.7% of sensitivity,and 95.5% of negative predictive value.ELISA had the greatest specificity（48.9%）.The five assays showed good correlations,with VIDAS DD and Liatest STAGO DD having the greatest correlation coefficient（r =0.9106）.VIDAS DD and Liatest STAGO DD correlated well with ELISA（r =0.8764 and r =0.8360 respectively）.Conclusion Liatest STAGO DD,DD Plus,and VIDAS DD have good diagnostic performance for the exclusion of VTE.They are easier and quicker to perform and can serve as an alternative test for ELISA.Further validation is needed for clinical applications.