婴幼儿配方食品中维生素D标准检验方法等效性评价研究

Equivalence evaluation of standard testing methods for vitamin D in infant formula food

目的评价研究婴幼儿配方食品中维生素D标准检验方法等效性。方法采用成对方法比较,通过实验室间比对研究,结合方法性能评价与运用合适统计工具对标准检验方法的分析结果进行定性定量评价。结果综合对方法性能与检测结果的评价,成对方法之间无显著性差异,在等效边界15%时方法等效,检测均值的差异均低于可接受临界差异。结论3对成对方法是等效的。方法等效性评价接受标准必须结合企业内部质量控制或监管层面实际的需求而定。

Objective To evaluate the equivalence of standard testing methods for vitamin D in infant formula food.Methods Pairwise method comparison from inter-laboratory testing was applied.The study was combined by method performance evaluation and analytical results evaluation using qualitative and quantitative statistical tools.Results Comprehensive evaluation of method performance and analytical results,there was no significant difference between the paired methods,the method was equivalent when the equivalent bound was 15%,and the difference of the testing mean was lower than the acceptable critical difference.Conclusion The 3 pairwise methods are equivalent.The acceptance criteria for method equivalence evaluation must be combined with the actual needs of the industry’s quality control or regulatory supervision.