D-二聚体定量检测校准方法的探讨

Calibration Methods of D-Dimer Quantitative Determination

目的应用新鲜血浆进行D-二聚体定量检测的结果比对和校准方法探讨。方法收集30份患者新鲜血浆,分别使用三种主流凝血分析仪检测D-二聚体,并进行结果比对。同时制备一组不同稀释度的血浆样本用作校准物,制作校准曲线对三种检测系统的结果一致化进行研究。结果三种凝血分析仪D-二聚体结果 (ng/m L)的中位数分别为:1 445、388、1 398。仪器两两之间的相关性分别为0.989、0.989和0.970。利用校准曲线校准后各标本结果与均值之比接近1。室间比对数据的CV分别由校准前的34.6%、41.9%和51.9%减小至校准后的28.3%、19.7%和13.3%。结论不同系统间D-二聚体检测结果相关性良好,但可比性差。利用患者混合血浆进行检测系统校准,可提高结果可比性。

Objective To study the comparison and calibration methods of D-dhner quantitative determination using fresh plasma. Methods The results of D-dimer obtained from 3 main coagulation analyzers were compared, ofwhich samples were collected from 30 patients. A set of different concentrations of plasma samples was pooled for calibrator preparation, which was used to produce curve for harmonization study. Results The median values of 3 analyzers were 1 445, 388 and 1 398, respectively. The correlation coefficients of each pair of the analyzers were 0.989, 0.989 and 0.970, respectively. The ratios of each sample result to mean values were all close to 1. The coefficients of variation ofinterlaboratory comparison data were down to 28.3%, 19.7% and 13.3% after calibration, respectively. Conclusions There is good correlation but poor comparability between instruments. The comparability is improved by calibration using patient＇s plasma.