两种试剂D-二聚体检测值与纤维蛋白降解产物值的相关性研究

摘要

目的：通过研究两种不同试剂 D-二聚体（D-DIMER）检测值与纤维蛋白降解产物（fibrin degradation products， FDP）的相关性，分析检测值的吻合度，评价两种检测试剂的临床实用性。方法采用Sysmex CA-1500全自动血凝分析仪检测患者D-二聚体及 FDP，D-二聚体检测试剂分别为 Siemens Innovance D-DIMER和 Dade Behring D-Dimer Plus。回顾性研究762例临床患者标本D-二聚体及 FDP测定结果，并将测定结果进行等级频数分析及等级相关检验（Spearman法）。结果 Siemens Innovance D-DIMER试剂检测同一患者D-二聚体值与 FDP水平呈正相关（r＝0.954，P＜0.01），优于 Sie-mens DD Plus试剂（r＝0.885，P＜0.01），且这种相关性随D-二聚体含量的升高而升高，当D-二聚体＞5 mg／L FEU时，相关性达到最佳（P＜0.01）。Innovance D-DIMER试剂组 FDP阳性率（约为65.76％）相对于 DD Plus试剂组（91.48％）偏低，提示 Innovance D-DIMER试剂组D-二聚体能够在 FDP升高之前出现反应，具有更高的灵敏度。结论使用 Siemens Innovance D-DIMER试剂检测D-二聚体并结合 FDP值可以为临床提供更加确切的疾病诊治信息。%Objective To evaluate the clinical practicality of two different D-dimer assays by studying the correlation of the testing results by two different D-dimer reagents with fibrin degradation products (FDP)result values and analyzing the Clinical alignment.Methods A representative cross-sectional study of 762 clinical patients’plasma specimens were taken to measure the results of D-dimer and FDP by using Sysmex CA-1500 automated coagulation analyzer,D-DIMER detection rea-gent respectively Siemens Innovance D-DIMER and Dade Behring D-DIMER Plus reagents.Then rating frequency analysis and Spearman correlation test were applied to analyze the correlation of measurement results.Results Overall,to the same patient,the correlation of D-dimer tested by Siemens Innovance D-DIMER Reagent with FDP level was significant positive (r= 0.954,P<0.01),better than that tested by Siemens DD Plus Reagent (r=0.885,P<0.01);and this correlation had an increasing trend when D-dimer level raised.When D-dimer level > 5 mg/L FEU,the correlation was the best (P<0.01). And by calculating the amount of positive FDP (FDP>5μg/ml)and FDP positive rate in both different cases when D-dimer results was also positive,FDP positive rate in Innovance D-DIMER Reagent group (about 65.76%)was lower than DD Plus Reagent group,it indicated that D-dimer results tested by Innovance D-DIMER Reagent could raise before FDP reacted,so D-dimer had a higher sensitivity than FDP.Conclusion It can provide a more precise clinical diagnosis and treatment infor-mation when using Siemens Innovance D-DIMER Reagent to detect D-dimer values and combined FDP values at the same time.