目的 结合国标要求和实际运用,发现目前国内外药品检验中进行实验室比对和能力验证过程常用统计方法的特点和适用条件。方法 本文根据ISO/IEC 17043-GB/T28043,从异常值的角度切入,将实验室在检测的稳定性、重复性能力作为重点;对目前国内外药品检验中进行实验室比对和能力验证过程常用统计方法进行了汇总和对比分析。重点分析能力评价的稳健统计Z比分数法和Grubbs检验的优劣。结果 通过对比研究得出不同方法的适用条件。结论 稳健Z比分数在现阶段能力验证结果分析中具有较明显优势。
Abstract
OBJECTIVE To identify the characteristics and application conditions of currently statistical methods for inter-laboratory comparison and proficiency testing results analysis in drug control, combining with the international standards and practical application. METHODS Based on the ISO/IEC 17043-GB/T28043, start beging with the definition of outliers, the methods currently used in inter-laboratory comparison and proficiency testing results analysis both at home and abroad methods were summarized and compared according to the ISO/IEC 17043-GB/T28043, with focused on the testing the stability and repeatability of laboratory testingproficiency. The most-used stastical methods of mter-laboratory comparison and proficiency testing during present clomestic and international drug testing was sumarrized and contratively analyzed. RESULTS The application conditions of different methods good contrast were providedidentified application condition of methods. CONCLUSION Robust Z-score has more advantages in current stage of inter-laboratory comparison and proficiency testing results analysis.
关键词
实验室比对 /
能力验证 /
离群值 /
稳健Z比分数 /
格鲁布斯检测
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Key words
inter-laboratory comparison /
proficiency testing /
outlier /
robust Z-score /
Grubbs test
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中图分类号：
R917
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参考文献
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