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生物样品分析中,由于基质成分的不同、蛋白结合的差异、已知和未知代谢物的转化、样品的不均一性和伴随服用的其他药物等原因,方法验证过程中使用的标准曲线和质控(QC)样品不能完全地模拟试验样品。这些因素在试验样品的储存、处理及检测过程中,可能会影响试验样品中待测物测定的准确度和精密度,因此需要采用试验样品再分析评估生物样品分析方法的重现性和准确性。本文首先介绍试验样品再分析的概念及在生物样品分析中发展的历程。然后对其重要性、实施规范、应用范围、样品选择、可接受标准、结果调查等方面进行综述,并对其失败原因进行分析和讨论,举例具体分析其主要的影响因素及如何利用其结果改进生物分析方法的质量,最后对其应用前景和发展方向进行展望。
In biological sample analysis, the standard curves and controls used in the validation process, due to differences in matrix composition, differences in protein binding, conversion of known and unknown metabolites, sample heterogeneity, and other medications that accompany the use of the method (QC) sample can not completely simulate the test sample. These factors may affect the accuracy and precision of test sample determination during the storage, handling and testing of test samples. Therefore, test sample reanalysis is needed to evaluate the reproducibility and accuracy of biological sample analysis methods . This article first introduces the concept of reanalysis of test samples and the history of their development in biological sample analysis. Then it summarizes its importance, implementation specification, application range, sample selection, acceptable standards, result investigation and so on. It also analyzes and discusses the causes of failure, and gives an example to analyze the main influencing factors and how to use the results to improve The quality of bioanalytical methods, and finally the prospect of its application and development direction.