McClure Foster D, Lee Jung K
U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Defense, Communication and Emergency Response, Division of Public Health and Biostatistics, 5100 Paint Branch Pkwy, College Park, MD 20740-3835, USA.
J AOAC Int. 2012 Jan-Feb;95(1):244-51. doi: 10.5740/jaoacint.11-031.
The validation process for an analytical method usually employs an interlaboratory study conducted as a balanced completely randomized model involving a specified number of randomly chosen laboratories, each analyzing a specified number of randomly allocated replicates. For such studies, formulas to obtain approximate unbiased estimates of the variance and uncertainty of the sample laboratory-to-laboratory (lab-to-lab) STD (S(L)) have been developed primarily to account for the uncertainty of S(L) when there is a need to develop an uncertainty budget that includes the uncertainty of S(L). For the sake of completeness on this topic, formulas to estimate the variance and uncertainty of the sample lab-to-lab variance (S(L)2) were also developed. In some cases, it was necessary to derive the formulas based on an approximate distribution for S(L)2.
分析方法的验证过程通常采用实验室间研究,该研究作为一个平衡完全随机模型进行,涉及指定数量的随机选择的实验室,每个实验室分析指定数量的随机分配的重复样本。对于此类研究,已开发出公式以获得样本实验室间标准偏差(S(L))的方差和不确定度的近似无偏估计,主要用于在需要制定包含S(L)不确定度的不确定度预算时考虑S(L)的不确定度。为了使该主题内容完整,还开发了用于估计样本实验室间方差(S(L)2)的方差和不确定度的公式。在某些情况下,有必要基于S(L)2的近似分布推导公式。