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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nifdc.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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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(英文):
分类号:R917
出版年·卷·期(页码):2018,38 (3):545-550
DOI: 10.16155/j.0254-1793.2017.01.01
-----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。

-----英文摘要:---------------------------------------------------------------------------------------

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.

-----参考文献:---------------------------------------------------------------------------------------

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[8] 柯培峰,梁铮,黄迪,等.化学发光检测系统参加CAP校准检验活动结果的分析[J],实用医学杂志,2011,27(12):2254 HE PF,LIANG Z,HUANG D,et al.Analysis of the results of CAP calibration verification in the chemiluminescence detection system[J].J Pract Med,2011,27(12):2254
[9] CNAS-RL02:2010,能力验证规则[S].2010:5 CNAS-RL02:2010,Rules for Proficiency Testing[S].2010:5
[10] 宋桂兰.能力验证工作历史回顾[J].中国计量,2009(2):35 SONG GL.The review of ability verification work history[J].China Metrol,2009(2):35
[11] 毛歆,项新华,肖新月.2013年食品药品系统实验室能力验证结果分析[J].中国药事,2015(29):1145 MAO X,XIANG XH,XIAO XY.Proficiency testing results of food and drug laboratories in 2013[J].Chin Pharm Aff,2015(29):1145
[12] CNAS-G03:2006,能力验证样品均匀性和稳定性评价指南[S].2015:4 CNAS-G03:2006,Guidance on Evaluating the Homogeneity and Stability of Samples Used for Proficiency Testing[S].2015:4
[13] CNAS-GL02:能力验证结果的统计处理和能力评价指南[S].2015:4.4 CNAS-GL02:Guidance on Statistic Treatment of Proficiency Testing Results and Performance Evaluation[S].2015:4.4
[14] GB/T 6379.2-2004,测量方法与结果的准确度(正确度与精密度)第2部分:确定标准测量方法重复性与再现性的基本方法[S].2005:7.3 GB/T 6379.2-2004,Accuracy(trueness and precision) of measurement methods and results-Part2:Basic method for the determination of repeatability and reproducibility of a standard measurement method[S].2005:7.3
[15] ISO 13528:2015,实验室间比对能力验证用统计方法[S].2015:8.5 ISO 13528:2015,Statistical methods for use in proficiency testing by interlaboratory comparison[S].2015:8.5

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