Innovance D二聚体检测量值与临界值适用性探讨

Application of Innovance D-dimer in Clinical Settings with Cutoff Evaluated

目的了解新型Innovance D-dimer在Sysmex CS2000(CS2000)全自动凝血分析仪上检测血浆D二聚体(D-dimer,D-D)的性能及其cutoff值的适用性。方法分别使用STA Liatest和Innovance D-D两种试剂在配套机型上检测100例患者的血浆D-D,分析两者的偏差和相关性,并根据排除静脉血栓的cutoff值判断两者符合率。结果在检测范围内两方法具有统计学相关(r=0.9516,P<0.05),不稀释标本(<4 mg/L)检测的相关性也具有统计学意义(r=0.9304,P<0.05)。以0.5 mg/L作为cutoff值,两种方法阴性、阳性和总体符合率分别为92.3%、98.6%和97%。结论Innovance D-D与现行主流方法在临床应用上具有量值可比性和诊断一致性。

Objective To investigate performance of Innovance D-Dimer measuring clinical samples on CS2000 automatic coagulation analyzer with its original cutoff. Method Samples from 100 patients with different diseases were test by STA Liatest D-Direct （with STA Evolution） and Innovance D-dimer respectively,bias between two sets of data and their correlation were analyzed, correspondent rate were calculated according cutoff ruling out venous thromboembolism. Results Data from two methods are correlated statistically not only in analysis range （ r = 0. 9304, P 〈 0.05 ） , but also in undiluted sample with D- dimer lower than 4 mg/L （ r = 0. 9304, P 〈 0.05 ）. Negative, positive and whole correspondent rate were 92.3 % ,98.6 % and 97 % taking 0.5 mg/L as cutoff. Conclusion Innovance D-dimer is comparative and correspondent with main stage method in clinical application.