摘要
目的:分析本实验室两台仪器Elecsys2010和Elecsys170同时测定血清神经元特异性烯醇化酶(NSE)和细胞角蛋白片段(CFYRA21-1)的结果,探讨这两个项目的可比性,以确保不同仪器在检测相同项目时结果的准确性和一致性。方法:根据美国临床实验室标准化委员会(NCCLS)EP9-A2文件的要求,以Elecsys2010为比较方法,Elecsys170为试验方法,平行测定40例病人血清中的NSE和CYFRA21-1浓度,计算各自的相关系数、直线回归方程和临界值处的相对偏差(SE%),并评价两方法检测结果的可比性。结果:(1)NSE和CYFRA21-1在两台仪器上的检测结果均有差异,Elecsys170的检测结果都低于Elecsys2010。(2)NSE和CYFRA21-1在两台仪器上的检测结果相关性均较好,相关系数都大于97.5%。(3)临床可接受性:NSE和CYFRA21-1在各自临界值处的偏差均在临床可接受的范围内。结论:当同一实验室同一检验项目存在2个以上的检测系统时,应进行方法比对和偏差评估,以保证检验结果的可比性。
Objective： To analyze the comparability of serum NSE and CYFRA21-1 to confirm the accuracy and consistency between the two instruments. Methods： According to National Committee for Clinical Laboratory Standards（NCCLS） document EP9- A2, Elecsys2010 （comparison method） and Eleesys170 （laboratory method） were used respectively to measure the serum concentrations of NSE and CYFRA21-1 of 40 patients. The correlation coefficient, the linear equation and the relative system bias （SE~） at their cutoff levels were measured subsequently to evaluate the comparability of the two instruments. Results. （1） Serum NSE and CYFRA21-1 were lower detected by Eleesysl70 than Elecsys2010. （2）Both of the two instruments had a great correlation and the correlation coefficient of each item was above 97.5%. （3） Clinical acceptability： The bias of NSE and CYFRA21--1 at their cutoff values were both acceptable in clinic. Conclusions： If the same test is determined in more than two systems, it is necessary to judge clinical acceptability by method comparison and bias estimation so as to insure the comparability.
出处
《四川生理科学杂志》
2012年第1期8-11,共4页
Sichuan Journal of Physiological Sciences
