Clinical Department of Laboratory Diagnostics, Clinical Hospital Centre and Department of Medical Informatics, Rijeka University School of Medicine, Rijeka, Croatia.
Biochem Med (Zagreb). 2011;21(1):49-52. doi: 10.11613/bm.2011.010.
The comparison of methods experiment is important part in process of analytical methods and instruments validation. Passing and Bablok regression analysis is a statistical procedure that allows valuable estimation of analytical methods agreement and possible systematic bias between them. It is robust, non-parametric, non sensitive to distribution of errors and data outliers. Assumptions for proper application of Passing and Bablok regression are continuously distributed data and linear relationship between data measured by two analytical methods. Results are presented with scatter diagram and regression line, and regression equation where intercept represents constant and slope proportional measurement error. Confidence intervals of 95% of intercept and slope explain if their value differ from value zero (intercept) and value one (slope) only by chance, allowing conclusion of method agreement and correction action if necessary. Residual plot revealed outliers and identify possible non-linearity. Furthermore, cumulative sum linearity test is performed to investigate possible significant deviation from linearity between two sets of data. Non linear samples are not suitable for concluding on method agreement.
方法比较实验是分析方法和仪器验证过程的重要组成部分。通过和 Bablok 回归分析是一种统计程序,它允许对分析方法的一致性和它们之间可能存在的系统偏差进行有价值的估计。它具有稳健性、非参数性、对误差分布和数据异常值不敏感。正确应用通过和 Bablok 回归的假设是连续分布的数据和两种分析方法测量的数据之间的线性关系。结果以散点图和回归线以及回归方程呈现,其中截距表示常数,斜率表示比例测量误差。95%置信区间的截距和斜率解释了它们的值是否仅因偶然而不同于零(截距)和一(斜率)的值,从而可以得出方法一致的结论,并在必要时采取纠正措施。残差图揭示了异常值,并确定了可能的非线性。此外,还进行了累积和线性检验,以研究两组数据之间是否存在线性的显著偏差。非线性样本不适合用于判断方法的一致性。