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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。
Objective To find out the characteristics and applicable conditions of statistical methods commonly used in the process of laboratory comparison and proficiency testing in drug testing at home and abroad based on the requirements and practical application of the national standard. Method According to the ISO / IEC 17043-GB / T28043, this paper focuses on the stability and reproducibility of the laboratory from the perspective of outliers. In the current domestic and international drug testing, the laboratory comparison and proficiency testing process Common statistical methods were summarized and comparative analysis. Focus on the ability to assess the robust statistical Z-score method and Grubbs test the pros and cons. The results obtained through the comparative study of different methods of application conditions. Conclusion The robust Z-score has more obvious advantages in the analysis of the proficiency testing results at this stage.