摘要
目的通过对同一检验科不同检测系统进行方法比对和偏差评估,探讨15项常规生化检测结果在不同检测系统间的可比性,为临床实验室认可以及不同实验室检验结果的互认提供依据。方法参考美国临床实验室标准化委员会(NCCLS)的EP9-A2文件,以检测系统Ⅰ(X)为比较方法,检测系统Ⅱ(Y1)、Ⅲ(Y2)为试验方法,检测患者新鲜血清中15项常规生化结果,用回归统计法分析不同系统的相对偏差或医学决定水平处的系统误差,以美国临床医学检验部门修正法规(CLIA′88)允许总误差的1/2为标准,判断检测系统间的可比性即临床可接受水平。结果试验系统Ⅲ(Y2)尿素低水平浓度值的SE%>1/2 CLIA′88 TEa,与目标检测系统(X)不具有可比性;其余项目测定结果和偏倚临床可接受。结论当使用两种以上检测系统检测同一项目时,应进行方法比对和偏倚评估,判断其临床可接受性,确保测定结果的可比性。该实验室3个生化检测系统间测定结果具有较好的可比性。
Objective To study the results comparability of 15 items detected by different biochemical testing systems with bias estimation and method comparison.Methods According to the document EP9-A2 of National Committee for Clinical Laboratory Standards（NCCLS）,15 biochemistry items were respectively detected by different biochemical testing systems and aim system to obtain the correlation coefficient and the linear equation.Then the system bias between self-built testing system and aim system could be evaluated by obtained equation.The comparability of different investigated systems was judged according to the half of clinical laboratory improvement amendment 88（CLIA′88） allowed total error.Results The results of urea（low level）,tested in system Ⅲ and aim system X showed no comparability（SE%1/2 CLIA′88 TEa）.There was comparability in other items.Conclusion If the same item is tested by more than two systems,it is necessary to judge clinical acceptability by method comparison and bias estimation so as to insure the comparability.The testing results of our three biochemical testing systems show well comparability.
出处
《检验医学与临床》
CAS
2011年第3期257-259,共3页
Laboratory Medicine and Clinic
基金
皖南医学院中青年科研基金(自然科学类)
关键词
比对研究
质量管理
偏倚
实验室认可
comparative study
quality management
bias
laboratory approbation
