两种分析系统血浆D-二聚体结果一致性分析  

Consistency Analysis of Plasma D-dimer Results in Two Analysis Systems

作　　者：石飞 孙建方 SHI Fei;SUN Jian-fang(Department of Clinical Laboratory,Zhangjiagang Central Hospital,Zhangjiagang,Jiangsu,215600,China;Department of Clinical Laboratory,Zhangjiagang Maternal and Child Health Care Hospital,Zhangjiagang,Jiangsu,215600,China)

机构地区：[1]江苏省张家港中心医院检验科,江苏张家港215600 [2]江苏省张家港市妇幼保健所检验科,江苏张家港215600

出　　处：《中国血液流变学杂志》2021年第1期108-109,F0003,共3页Chinese Journal of Hemorheology

摘　　要：目的比较两种方法学平台检测D-二聚体结果的一致性。方法分别采用迈瑞C-3510全自动血凝分析仪、贝克曼AU-680全自动生化分析仪检测107例患者血浆D-二聚体水平并进行统计学分析。结果迈瑞C-3510全自动血凝分析仪(实验方法)和贝克曼AU-680全自动生化分析仪(参考方法)检测107例患者D-二聚体的结果分别为1.364(0.20,18.40)mg/L和2.062(0.12,32.90)mg/L,差异有统计学意义(P<0.001);两种方法结果间总符合率为85.0%(95%CI 77.1%~90.6%),阳性符合率为98.2%,阴性符合率为71.2%,对称性试验(McNemar Test)未通过,实验方法结果高于参考方法,差异具有统计学意义(ChiSq=12.250,1df,P<0.001);Cohen's Kappa系数0.698(95%CI 0.562~0.835)。结论两种不同方法学平台检测D-二聚体阳性率结果存在差异,实验方法显著高于参考方法。应根据不同检测系统制定相应的诊断临界值,加强与临床的沟通,更好地服务于患者。Objective To compare the consistency of the results of D-dimer detected by two methodological platforms.Methods The plasma D-dimer levels of 107 patients were detected by Mindray C-3510 automatic hemagglutination analyzer and Beckman AU-680 automatic biochemical analyzer and statistical analysis was performed.Results The results of D-dimer detected by Mindray C-3510 automatic hemagglutination analyzer(experimental method)and Beckman AU-680 automatic biochemical analyzer(reference method)in 107 patients were 1.364(0.20,18.40)mg/L and 2.062(0.12,32.90)mg/L,respectively,the differences were statistically significant(P<0.001);and the total coincidence rate between the two methods was 85.0%(95%CI 77.1%-90.6%).The positive coincidence rate was 98.2%,while the negative coincidence rate was 71.2%.Symmetry test(McNemar Test)failed.The results of the experimental method are higher than those of the reference method,the differences were statistically significant(ChiSq=12.250,1df,P<0.001);Cohen's Kappa coefficient was 0.698(95%CI 0.562-0.835).Conclusion There is a difference in the positive rate of D-dimer detected by two diferent methodological platforms,the results of experimental method are significantly higher than the reference method.The diagnostic thresholds should be established according to different detection systems,strengthen communication with the clinic,and better serve patients.

关 键 词：血凝分析仪 生化分析仪 D-二聚体 符合率 一致性 

分 类 号：R587.1[医药卫生—内分泌]