摘要
目的参照美国临床实验室标准化协会(NCCLS)颁布的EP10-A2文件初步评价便携式全自动快速(干式)生化分析仪及配套肝肾功能试剂盘,探讨其临床应用性能。方法按照NCCLS颁布的EP10-A2文件,按中、高、低、中、中、低、低、高、高、中的顺序连续测定各浓度样本5 d,计算测定结果的偏差、总不精密度,对截距、斜率、非线性、携带污染和漂移进行多元回归分析。结果各项目高、中、低浓度样本偏差均未超过美国临床实验室改进修正法规1988要求的总容许误差的1/4,总不精密度在允许范围内,截距、斜率、非线性、携带污染、漂移差异均无统计学意义(P>0.05)。结论便携式生化分析仪及配套肝肾功能试剂盘准确度、精密度良好,线性关系良好,携带污染率较低,稳定性好,能满足临床应用要求。
Objective Preliminary evaluation of portable analyzer and reagent disc kit for liver and kidney function tests was performed according to Clinical and Laboratory Standards Institute（ NCCLS） EP 10- A2,so as to explore its clinical performance. Methods According to the NCCLS EP10- A2,specimens at different concentrations were measured continuously at the order of medium,high,low,medium,medium,low,high,high,medium for 5 days. The bias and the total imprecision were calculated,the intercept,slope rate,non linearity,carryover contamination and drift were conducted for multiple regression analysis. Results The bias at high,medium and low concentrations was not exceed 1 /4 of the total allowable error of the Clinical Laboratory Improvement Amendments in 1988,and the precision was within acceptable ranges. There was no statistical significance on the differences among intercept,slope rate,non linearity,carryover contamination and drift（ P〉 0. 05）. Conclusion Portable analyzer and reagent disc kit for liver and kidney function tests are of fine bias,fine precision,fine linearity,low carryover contamination and good stability,which can meet clinical application requirement.
出处
《中国卫生检验杂志》
CAS
2016年第2期219-221,共3页
Chinese Journal of Health Laboratory Technology
基金
宁波市社科类项目(2013C50047)
宁波市社会发展科技项目(2013C50047)
关键词
便携式生化分析仪
肝肾功能试剂盘
EP10-A2
初步评价
Portable analyzer
Reagent disc kit for liver and kidney function tests
EP 10-A2
Preliminary evaluation
