Innovance D-dimer 试剂在血栓形成早期的筛查价值

目的：评价 Innovance D-dimer 试剂性能及其在血栓形成早期的临床筛查价值。方法采用 Innovance D-dimer 检测试剂，分别对86例疑似血栓患者（血栓组）和40例门诊健康体检者（对照组）进行血浆 D-二聚体水平测定，并进行统计学 t 检验，受试者工作特征曲线（ROC）分析和筛检评价。结果血栓组 D-二聚体水平（4．14±7．29）mg/L]显著高于对照组（0．1±0．12）mg/L]，差异有统计学意义（P ＝0．000）。ROC 曲线分析结果显示，D-二聚体水平用于血栓的临床筛查有显著统计学意义（AUC＝0．938，P ＝0．000），D-二聚体水平越高，发生血栓的可能性越大；以 D-二聚体水平为0．50 mg/L 为截断值，其灵敏度、特异度和阴性预测值表现良好，分别为98．08％和100．00％和98．67％。结论Innovance D-dimer 试剂适用于排除血栓形成，但诊断价值有限。

Clinical screening value of Innovance D-dimer assay in early thrombosis patients

Objective To evaluate the diagnostic value of Innovance D-dimer assay in patients with early thrombosis.Methods The D-dimer level was detected in 86 patients suspected with thrombosis and 40 healthy control subjects by using Innovance D-dimer reagent.Results The D-dimer level was significantly higher in the case group（4.14±7.29）mg/L]than in the control group （0.17±0.12）mg/L],P =0.000.ROC curve analysis showed that D-dimer was a significant indicator for the clinical screening of thrombosis,and the higher D-dimer level,the greater possibility of thrombosis（AUC=0.938,P =0.000）.The sensitivity,specificity and negative predictive value have the satisfactory performance under the cut-off value of 0.50 mg/L.Conclusion The Innovance D-dimer is useful for excluding patients suspected with thrombosis,but it has a limited value in diagnosis of thrombosis.