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[(0.17±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0.50mg/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。
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-di-mer 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,specifici-ty 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.