两种方法检测D二聚体的比较分析  

Comparison of Two Methods for Detection of D-dimer

作　　者：杨平平 王坤[1] 刘红丽[1] 薛燕平[1] YANG Ping-ping;WANG Kun;LIU Hong-li;XUE Yan-ping(Department of Clinical Laboratory of Huang He Hospital in Sanmenxia,Henan Sanmenxia,472000,China)

机构地区：[1]河南省黄河三门峡医院检验科,三门峡472000

出　　处：《血栓与止血学》2018年第5期772-774,777,共4页Chinese Journal of Thrombosis and Hemostasis

摘　　要：目的通过对全自动血凝仪(ACL-TOP700)和全自动荧光分析仪(VIDAS)检测结果的比较分析,评估TOP700 Hemos IL D-dimer试剂检测D二聚体(D-D)的临床效能。方法根据ACL-TOP700全自动血凝仪Hemos IL D-dimer试剂测试结果,结合项目的医学决定水平和两种方法的参考区间来选择合适浓度临床样本,且均匀分布,再把"D二聚体检测"急诊临床应用专家共识提出的金标准VIDAS D二聚体检测"作为参考平台,进行方法学比对试验。并应用Bland-Altman分析法评估其一致性。结果定性判断TOP700 Hemos IL D-Dimer检测假阳性率、假阴性率和总符合率分别为18%、0、95.5%,Kappa值为0.872,表明两种方法有较好的一致性;两种方法定量检测D-D结果差异无统计学差异,P=0.0071,其相关系数r=0.916,Passing-Bablock回归方程为Y=-15.32+0.894 x,截距A的系统差异95%CI为-150.9834-83.7898,斜率B的比例差异95%CI为0.7331-0.9834,线性度无明显偏差(P=0.36)。表明两种方法有较好的线性相关性。且Bland-Altman差异图显示,配对数据差值的平均值为-278.6 ng/ml FEU。95%一致性界限为-3414.3ng/ml FEU,2857.1 ng/ml FEU,在临床上可以接受。结论 TOP700Objective To study clinical efficient of TOP700 HemosIL D-dimer（D-D） reagent in detecting D-Dimer by comparing and analyzing the results of automatic coagulation analyzer（ACL-TOP700）and automatic fluorescence analyzer（VIDAS）.Methods Selected and uniformly distributed samples of appropriate concentration,according to test results of HemosIL D-dimer reagent of ACL-TOP700 automatic coagulation analyzer and level of medical decision-making of project.Then the ＂D-dimer Body test＂ as a reference platform for the methodological comparison from Gold standard VIDAS D-dimer test proposed by experts in emergency clinical application＂,and its consistency was evaluated by Bland-Altman analysis.The results exhibition that false positive rate,false negative rate and total coincidence rate of TOP700 HemosIL DD assay were 18%,0 and 95.5%,respectively,and the Kappa value was 0.872,which showed that the two methods had good consistency.There was no significant difference between quantitative detection of D-D results（P = 0.0071,r = 0.916,Passing-Bablock regression equation was Y=-15.32 ＋ 0.894 x,95% CI of intercept A was-150.9834-83.7898,The difference in slope B,95% CI,was 0.7331-0.9834 with no significant deviation in linearity（P = 0.36）.The results shows that two methods have better linear correlation.Moreover,Bland-Altman difference plot shows that the average of paired data difference is-278.6 ng/ml FEU and 95% agreement limit was-3414.3 ng/ml FEU,2857.1 ng/ml FEU,which is acceptable in clinically measurement.Conclusion TOP700 D-Dimer reagent can meet clinical D-D detection needs to clinically measurement

关 键 词：TOP VIDAS D二聚体 

分 类 号：R446[医药卫生—诊断学]