摘要
目的通过对国产红细胞叶酸检测仪进行性能分析,以验证其检测能力是否符合行业标准。方法参考美国临床和实验室标准化协会EP5-A2文件,通过20d测定2个水平质控物,获得精密度实验数据,计算批内、批间和实验室内变异系数(CV)并与生物学变异规定的要求相比较;按照EP9-A2文件,通过与Beckman Couter UniCel DxI800全自动免疫分析仪测定结果比对验证仪器的正确度;参照EP6-A文件,用多项式回归法进行线性评价;通过测定20例能够合理代表健康总体的样本对仪器给定的参考范围进行验证。结果批内CV小于6.67%(1/4生物学变异允许总误差),批间CV小于8.90%(1/3生物学变异允许总误差),实验室内CV小于13.35%(1/2生物学变异允许总误差);在医学决定水平处预期偏倚的可信区间小于允许的误差范围;二次和三次多项式系数与0比较差异均无统计学意义,检测系统呈线性;厂家给定的参考范围不适合本实验所在地人群。结论国产红细胞叶酸检测仪精密度、正确度和线性符合要求;实验室应建立适合当地人群的参考范围。
Objective Through performance analysis of domestic red blood cells folic acid instrument to verify its testing ability.Methods According to national committee for clinical laboratory standards（NCCLS）EP5-A2,the precision was obtained through two level quality product detection within 20 days then the intra-assay variation coefficient（CV）,inter-assay CV and CV in laboratory was calculated and compared with the precision requirement coming from the red blood cells folic acid biological variation.According to EP6-A,the linear evaluation was investigated with method of polynomial regression.By measuring the red blood cells folic acid from 20persons who presented the total healthy people,the reference scope given by the manufacturer was verified.Results Within the group CV was less than 6.67%（1/4 of biological variation allow total error）,between the group CV was less than 8.90%（1/3 of biological variation allow total error）,the laboratory CV was less than 13.35%（1/2 of biological variation allow total error）.At medical decision level,the calculated bias and the confidence limit were smaller than the allow range of error.Both factors of quadratic polynomial and cubic polynomial regression models were not statistically significant compared with zero,so detection system was linear.The reference scope given by manufacturer was not suitable for the local people.Conclusion The precision,accuracy and linearity of domestic red blood cells folic acid analyzer were accord with requirements.The laboratory should establish reference interval suitable for the local population.
出处
《重庆医学》
CAS
CSCD
北大核心
2013年第22期2635-2637,2640,共4页
Chongqing medicine
基金
国家高技术研究发展计划(863计划)基金资助项目(2011AA02A111)
首都卫生发展科研专项基金资助项目(2011-2008-02)
北京世纪坛医院科研项目(2011-C29)
关键词
红细胞叶酸
叶酸检测仪
性能评价
blood cells folic acid
folic acid analyzer
performance assessment
