应用EP9方案评价不同分析系统间DD二聚体结果的一致性  

Application of EP9 plan in evaluating the consistency of D-dimer detection results by different analysis systems

作　　者：李飞[1] 王乐见 孙书美[2] 徐友文[1] 

机构地区：[1]台州市中心医院检验中心,浙江台州318000 [2]台州市中医院检验科,浙江台州318000

出　　处：《中国卫生检验杂志》2014年第1期92-94,共3页Chinese Journal of Health Laboratory Technology

摘　　要：目的评价Stago STA-R血凝仪和Sysmex cs-2100i血凝仪检测DD二聚体结果的一致性可比性,为实验室间检验结果的互认和临床认可提供依据。方法按照美国临床实验室标准化委员会(NCCLS)EP9-A2文件要求,以Stago STA-R血凝仪为比较系统,以Sysmex cs-2100i血凝仪为试验系统,每天选取8份不同浓度患者新鲜标本在两系统分别进行检测,连续5 d,检测结果用Excel2003和SPSS17.0统计软件进行处理,计算两系统检测结果的相关系数(r)及直线回归方程,以允许总误差(TEa)的1/2为判断依据,判断两系统之间测定结果的一致性可比性。结果 DD二聚体在两台仪器上测定结果的相关系数>0.975,偏倚在要求范围内。结论当同一检验项目使用不同分析系统进行检测时,为保证不同系统间测定结果具有可比性,需要定期对系统间进行偏倚评估和比对。本实验室的Stago STA-R血凝仪和Sysmex cs-2100i血凝仪测定DD二聚体的结果具有较好的可比性。Objective To understand the comparability of Stago STA - R automatic coagulometer and Sysmex cs -2100i auto- matic coagulometer in detection of D -dimer, so as to provide the baisis for mutual recognition of test results and clinical labora- tory accreditation. Methods Using EP9 - A2 document of NCCLS, Stago STA - R automatic coagulometer as the comparative system（ X）, and Sysmex cs -2100i automatic coagulometer as test system（Y） were involved to detect 8 fresh serum samples from patients at different concentrations daily for 5 d. The correlation coefficient （r） and the linear regression equation of D - dimer detection by the two analysis systems were calculated to assess the comparability, with 1/2 of the allowabs total error as cut - off value. Results The correlation coefficients of D - dimer measurement by the two instruments were greater than 0.975, and bias were all in clinical tolerance range. Conclusion When using two or more detection systems to analyze the same pro- ject, method comparison and bias estimation can ensure the comparability of measurement results. The two automatic coagulometers had good comparability in detection of the concentrations of D - dimer.

关 键 词：DD二聚体 Stago STA—R血凝仪 SYSMEX CS-2100i血凝仪 可比性 

分 类 号：R446.11[医药卫生—诊断学]