D二聚体定量测定排除静脉血栓的一致性研究

目的通过影像学检查和血浆D二聚体定量筛查疑似深静脉血栓形成(DVP)患者,调查不同抗体来源试剂的检测一致性。方法选择2016年1~10月就诊的220例疑似患者和100例健康体检者,使用MediRox D-dimer和STA Liatest D-dimer两种试剂检测受检者血浆D二聚体,并以影像学检查结论作为诊断DVP的依据。结果 220例疑似患者经影像学确诊的深静脉血栓71例,肺栓塞35例。D二聚体高于Cutoff者176例,两组结果的差异没有统计学意义(t=-1.120,P=0.264),并且存在线性关系y=0.1564+0.9831 x,R~2=0.958(r=0.979,P0.01)。两种方法检测320例标本的差异83%在±0.5μg/ml以内,临界值附近(0.2 to 0.9μg/mL)检测95%的偏差在0.32μg/ml以内,标准偏差0.156μg/ml。结论 D二聚体用于DVP排除诊断时,除了要结合影像学检查之外,要求定性判断的高符合率和阳性数据的相关性。

Study on The Consistency of Quantitative Determination of D-dimer in the Exclusion of Venous Thrombosis

Objective To investigate the harmonization of reagents including different antibodies in screening of deep venous thrombosis (VTE).Methods 220 patients suspected VTE and 100 healthy volunteers were enrolled in Jan to Oct 2016,plasma D-dimer was tested by reagents from MediRox and Stago (STA Liatest),then validated by imaging for diagnosis.Results 71 Deep venous thromboembolism and 35 pulmonary embolisms were confirmed in 176 patients whose D-dimer over the cutoff for VTE,no statistic difference could be found between reagents groups (t =-1.120,P =0.264),which showed linearity iny =0.1564 + 0.9831 x,R2 =0.958 (r =0.979,P ＜ 0.01).83％ differences between groups were less than 0.5microg/ml,in all 320 cases.Average biases around the cutoff(0.2 to 0.9 microg/mL)were 0.156 microg/ml,95％ of which less than 0.32 microg/ml(1.96 SD).Conclusion High accordance rate in qualitive result and linearity in positive are necessary for different D-dimer assays in screening VTE with imaging applied.