生物样品分析中的试验样品再分析研究进展  

Research progress of incurred sample reanalysis in bioanalysis

作　　者：张煊 闫冬 高静 谢小青[2] 

机构地区：[1]辽宁亿灵科创生物医药科技有限公司,本溪117004 [2]沈阳亿灵医药科技有限公司,沈阳110179

出　　处：《药物分析杂志》2015年第3期383-388,共6页Chinese Journal of Pharmaceutical Analysis

基　　金：国家"重大新药创制"科技重大专项(2014ZX09201002)

摘　　要：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。Calibration standards and QC samples used during validation may not mimic the actual test samples in bioanalytical research due to differences in matrix compositions and protein binding,back- conversion of known and unknown metabolites,sample inhomogeneity and concomitant medications which may affect the accuracy and precision of sample assay during storage,processing and detection. It is therefore recommended to evaluate the reproducibility and accuracy of the validated method by reanalysis of incurred samples. This paper first introduced the general principles of incurred sample reanalysis（ ISR） and development process in bioanalysis. Then,this paper reviewed the importance,conducting specification,applicable scope,sample selection,acceptance criteria and result investigation of ISR,analyzed the causes of test failure and discussed the main influencing factors through several case studies and proposed advice to improve the quality of bioanalytical methods according to results of ISR. Last,this paper discussed the perspective in the use of ISR in the future.

关 键 词：生物样品分析 试验样品再分析 试验样品重现性 试验样品稳定性 试验样品准确度 加样样品 标准曲线样品 质控样品 生物分析质量改进 

分 类 号：R917[医药卫生—药物分析学]