生物样本库国际认可和标准化发展与前景  

The development and prospect of international accreditation and standardization on Biobank

作　　者：翟培军[1] 李军燕[1] 胡冬梅[1] 周亚莉[1] 白倞怿 张小燕[2] 郜恒骏[2] 

机构地区：[1]中国合格评定国家认可中心,北京100055 [2]生物芯片上海国家工程研究中心,201203

出　　处：《中华临床实验室管理电子杂志》2017年第1期6-8,共3页Chinese Journal of Clinical Laboratory Management(Electronic Edition）

基　　金：中国合格评定国家认可中心资助课题(2016CNAS03)

摘　　要：生物资源对生命科学的研发及其应用至关重要,生物样本库是构建和管理用于临床研究所需的生物资源,也是探索疾病发生、发展、转归、诊断和治疗,以及药物研发、健康预防等研究与转化应用的重要基础。以标准化的方式进行样本采集、处理、运输、存贮及检索与查询,是正确使用和共享生物样本资源的根本保证,建立这样一个保存和提供生物资源的管理体系具有重要意义。共享应用是生物资源的一个重要价值和作用,取决于人们对生物样本库保藏能力和生物资源质量的信心,第三方权威机构的能力评价和证实亦非常重要。面对我国生物样本库的建设缺乏规范的生物样本库建设标准的指导,亦无适用的评价制度予以证实等问题,根据我国行业需求,中国合格评定国家认可委员会利用国际任职便利条件,开展了生物样本库认可和标准化的国际调查活动,旨在了解和借鉴其他国家的做法和思路,推动我国生物样本库标准化建设和评价体系建立。Biological resources are essential for the development and application of life sciences. Biobank is an important foundation and provides resources for biomedical and clinical research to study etiology of diseases, clinical diagnosis and treatment, drug targets discovery, prevention in term of translational research. To standardize collecting, preparing, shipping, storing and retrieving samples are essential to the proper use and sharing of sample resources. It is important to establish a management system that can manage preservation and provision of biological resources in consistent way across biobanks. Sharing samples and associated data are of critical values for biobanks, which would depend on confidence in the capacity and quality of biological resources in the biobanks. The capacity evaluation and validation by a third-party authority is also very important and should serve as one of the major components in the system. The challenges of us facing are lacking a standardized guidance to build biobank, and evaluation system for biobanking management. According to growing demands for the field in China, China National Accreditation Service for Conformity Assessment has conducted aninvestigation on accreditation and standardization of biobanks around the world, which aimed at understanding and learning from the practices and ideas of other countries, promoting the construction of the biobank standardization and evaluation.

关 键 词：生物样本库 质量管理 认可 标准化 

分 类 号：R197.3[医药卫生—卫生事业管理]