pH测定检验能力验证及评价新方法的应用  

Application of new methods to the proficiency testing project of pH determination and its evaluation

作　　者：赵新玥 赵文[2] 陈华[2] ZHAO Xin-yue1,2, ZHAO Wen2 , CHEN Hua2.(1. Wuxi Institute for Drug Control,Wuxi 214028,China; 2. National Institutes for Food and Drug Control, Beijing 100050, China)

机构地区：[1]无锡市药品安全检验检测中心,无锡214028 [2]中国食品药品检定研究院,北京1000502

出　　处：《药物分析杂志》2018年第3期545-550,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:评价参与能力验证实验室的pH测定能力,探讨能力验证结果评价的方法。方法:根据CNAS(中国合格评定国家认可委员会)规定的程序组织能力验证,借助JMP软件对制备样品进行均匀性和稳定性检验,通过分析专家实验室的重复性和再现性标准差来确定能力评定的标准差,以Z比分数对结果进行评价。结果:共有251家参加实验室,实验室总的满意率为86.45%,可疑率为4.78%,不满意率为8.76%。结论:在本次能力验证中,使用了新统计评价方法与统计工具,与国内外常用方法相比具有显著优势。Objective： To evaluate the capacity of laboratories which participated in the proficiency testing for pH determination and explore the statistical methods for proficiency testing. Methods： The study was performed according to the procedure of China National Accreditation Service for Conformity Assessment （ CNAS ）. JMP was used to evaluate the homogeneity and stability of the test samples. All results conformed to the requirements. Z-scores were calculated using the results of expert laboratories, assigned value and the standard deviation for proficiency assessment. These scores were used to evaluate results. Results： A total of 251 labs participated. The satisfaction rate of the laboratory was 86.45%, the suspicious rate was 4. 78%, the rate of dissatisfaction was 8.76%. Conclusion： In the proficiency testing, we used the new statistical evaluation method and statistical tools. The new method has a significant advantage compared with common methods.

关 键 词：能力验证 Z比分数 JMP 精密度试验 柯克伦检验 格拉布斯检验 

分 类 号：R917[医药卫生—药物分析学]