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生物样本库的基本原则:从生物样本到患者的精准医疗。

Basic principles of biobanking: from biological samples to precision medicine for patients.

机构信息

Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Italy.

Department of Medical Sciences, University of Turin, Turin, Italy.

出版信息

Virchows Arch. 2021 Aug;479(2):233-246. doi: 10.1007/s00428-021-03151-0. Epub 2021 Jul 13.

Abstract

The term "biobanking" is often misapplied to any collection of human biological materials (biospecimens) regardless of requirements related to ethical and legal issues or the standardization of different processes involved in tissue collection. A proper definition of biobanks is large collections of biospecimens linked to relevant personal and health information (health records, family history, lifestyle, genetic information) that are held predominantly for use in health and medical research. In addition, the International Organization for Standardization, in illustrating the requirements for biobanking (ISO 20387:2018), stresses the concept of biobanks being legal entities driving the process of acquisition and storage together with some or all of the activities related to collection, preparation, preservation, testing, analysing and distributing defined biological material as well as related information and data. In this review article, we aim to discuss the basic principles of biobanking, spanning from definitions to classification systems, standardization processes and documents, sustainability and ethical and legal requirements. We also deal with emerging specimens that are currently being generated and shaping the so-called next-generation biobanking, and we provide pragmatic examples of cancer-associated biobanking by discussing the process behind the construction of a biobank and the infrastructures supporting the implementation of biobanking in scientific research.

摘要

“生物库”一词常被错误地应用于任何人类生物材料(生物样本)的收集,而不论与伦理和法律问题相关的要求或组织涉及的不同过程的标准化如何。生物库的正确定义是与相关个人和健康信息(健康记录、家族史、生活方式、遗传信息)相关联的大量生物样本的集合,主要用于健康和医学研究。此外,国际标准化组织在阐述生物库的要求(ISO 20387:2018)时,强调了生物库作为法律实体的概念,推动了获取和存储过程,以及与收集、准备、保存、测试、分析和分发定义生物材料以及相关信息和数据相关的一些或全部活动。在这篇综述文章中,我们旨在讨论生物库的基本原则,从定义到分类系统、标准化过程和文件、可持续性以及伦理和法律要求。我们还涉及目前正在产生并塑造所谓的下一代生物库的新兴样本,并通过讨论生物库建设背后的过程以及支持生物库在科学研究中实施的基础设施,提供癌症相关生物库的实用示例。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc77/8364535/780b0c5a2927/428_2021_3151_Fig1_HTML.jpg

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