浅谈生物样本的质量保证与质量控制  

Quality assurance and quality control of biospecimen

作　　者：郭丹[1,2] 王安琪[1] 孙健[1,3] 徐英春[1,4] 

机构地区：[1]中国医学科学院北京协和医学院北京协和医院生物标本中心,100730 [2]中国医学科学院北京协和医学院中心实验室,100730 [3]中国医学科学院北京协和医学院病理科,100730 [4]中国医学科学院北京协和医学院检验科,100730

出　　处：《中华临床实验室管理电子杂志》2017年第1期36-45,共10页Chinese Journal of Clinical Laboratory Management(Electronic Edition）

基　　金：国家十二五重大专项子课题资助项目(2011ZX09307-001-01);国家重点研发计划项目(2016YFC1201703)

摘　　要：随着转化医学的快速发展,临床生物样本库的建设和应用得到日益发展与重视,而生物样本的质量保证和质量控制是样本库建设的核心目标。影响生物样本质量的主要因素可分为分析前和分析中两大因素,涉及捐赠者的生物学和环境因素、样本的采集、处理、运输、储存、分发、分析等各环节。这些环节同时与人员、仪器、材料、方法、环境等要素相互作用共同影响着生物样本的质量。因此,单一因素控制和质量分析是无法保证高质量的样本以及相应的产出和临床转化应用,需要通过建立完善的质量管理体系给予多因素、全流程控制,并在生物样本库领域建立国际标准化的认证和认可,才能促进生物样本质量和研究水平快速提升,为疾病标志物检测、个体化医疗、药物研发等转化医学研究提供支持。With the fast growth and increasing demands for translational research, collection of clinical research resources in biobanks around the world has brought us a big concern about sample quality and its usability. Quality assurance（QA） and quality control （QC） of biospecimen are the key factors of biobank quality and usability. The main factors influencing the quality of biospecimen are pre-analytical and analytical variables, including the donor＇s biological and environmental factors, biospecimen collection, processing, transportation, storage, distribution, analysis and so on. Those factors such as personnel, equipment, material, method and environment, which could interact with pre-analytical and analytical variables, directly influence the quality of biospecimen, so it is difficult to guarantee quality samples in clinical translational research if only single factor is applied to sample quality management. We should develop a quality management system specific to quality control of biobank. The goal is to gradually develop international standardization and accreditation. Taking together, it would facilitate quality samples for quality research as clinical research resources in term of biomarker and drug discovery for both translational and personal medicine.

关 键 词：临床生物样本库 质量控制 质量保证 转化医学 

分 类 号：R197.3[医药卫生—卫生事业管理]