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[当前最佳实践与生物样本库建议。]

[Current best practices and biobanking recomedations.].

作者信息

Doludin Y V, Borisova A L, Pokrovskaya M S, Stefanyuk O V, Sivakova O V, Botsoeva S A, Meshkov A N, Metelskaya V A, Drapkina O M

机构信息

FSI National Research Center for Preventive Medicine of the Ministry of Healthcare of the Russian Federation, 101990, Moscow, Russia.

FSI 52 Consulting and Diagnostic Center of the Ministry of Defense of the Russian Federation, 125167, Moscow, Russia.

出版信息

Klin Lab Diagn. 2019;64(12):769-776. doi: 10.18821/0000-0000-0000-00-0-0-00.

DOI:10.18821/0000-0000-0000-00-0-0-00
PMID:32040903
Abstract

The biobank is a structure established with the goal of long-term responsible storage of biological samples and the associated data for their further use in scientific and clinical research. The objectives of biobanking are the creation of unified recommendations on: the planning of premises and the selection of equipment for storage; development of management methods and staff training; standardization of methods for the collection, shipping, processing and storage of biomaterial of various origins, as well as methods for quality control and validation of the applied methods; creation and use of databases of information accompanying biospecimens. The lack of common standards for conducting the preanalytical phase has been the cause of low accuracy and poor reproducibility of research results. To date, a large number of guidelines and best practices have been published that provide an answer to a wide range of problems in organizing the biobanking process. The article provides an overview of the most famous biobanking guidelines that can be used to solve various research problems. Biobanking in Russia is actively developing. Since 1996 there is a work on the legislative regulation of biobanking activities, as a result of which a number of regulatory documents have been issued. An important stage in the development of biobanking in Russia was the establishment of the "National Association of Biobanks and Biobanking Specialists" (NASBio) in 2018, which included representatives of medical and research institutions, commercial firms, and qualified specialists in the field of biobanking. One of the key tasks of NASBio is the adaptation and implementation of the best biobanking practices in Russian research institutes and centers. The use of modern guidelines and best practices on biobanking will lead to an increase in the quality of research and publications.

摘要

生物样本库是一种为长期负责存储生物样本及相关数据以用于科学和临床研究而建立的结构。生物样本库的目标是就以下方面制定统一建议:存储场所的规划和设备的选择;管理方法的制定和人员培训;各种来源生物材料的采集、运输、处理和存储方法的标准化,以及应用方法的质量控制和验证方法;生物样本相关信息数据库的创建和使用。分析前阶段缺乏通用标准一直是研究结果准确性低和可重复性差的原因。迄今为止,已经发布了大量指南和最佳实践,为生物样本库组织过程中的各种问题提供了答案。本文概述了可用于解决各种研究问题的最著名的生物样本库指南。俄罗斯的生物样本库正在积极发展。自1996年以来,一直在开展生物样本库活动的立法监管工作,结果发布了一些规范性文件。俄罗斯生物样本库发展的一个重要阶段是2018年成立了“国家生物样本库和生物样本库专家协会”(NASBio),其成员包括医疗和研究机构、商业公司以及生物样本库领域的合格专家。NASBio的关键任务之一是在俄罗斯研究机构和中心采用和实施最佳生物样本库实践。使用现代生物样本库指南和最佳实践将提高研究和出版物的质量。

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Klin Lab Diagn. 2019;64(12):769-776. doi: 10.18821/0000-0000-0000-00-0-0-00.
2
ISO 20387 biobanking standard. Analysis of requirements and experience of implementation.ISO 20387 生物库标准。需求分析与实施经验。
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