脑血管病生物样本库建设标准研究

doi:10.3969/j.issn.1673-5765.2021.05.006

摘要/Abstract

摘要：

目的开发适合我国脑血管病精准医学研究的生物样本库建设及管理标准，为建设可开发共享的脑血管病生物样本库提供技术保障。方法参考国际大型生物样本库建设经验，基于国际标准化组织等机构的标准化思路，形成我国脑血管病生物样本库建设标准框架，从场地设施、设备、操作规程、数据标准、信息化等多个维度，对样本库的建设提出技术要求。结果依据本研究提出的建设标准，建立了符合国际标准的天坛脑血管病生物样本库运行及质量管理体系，建成标准化采集、处理、保藏的10万人次脑血管病临床研究生物样本资源平台。结论天坛脑血管病生物样本库具有样本量充足、多样、多时点采集的生物样本资源，并实现了标准化的信息存储，可为对接脑血管病多组学研究，脑血管病精准筛查、预警、诊断与干预等精准医学研究提供技术支撑。

文章导读： 规范化的脑血管病生物样本库能打造集临床数据与生物样本于一体的资源管理平台，基于规范的临床数据及生物样本采集管理机制、严格的质量控制体系及标准的超低温保存条件，充分利用脑血管病临床资源，实现资源的有效整合、管理和共享。

关键词: 生物样本库; 脑血管病; 临床研究; 建设规范

Abstract:

Objective To develop construction and management standards for cerebrovascular diseases (CVD) biobank for CVD precision medicine research in China, and provide technical support for building CVD biobank that can be shared. Methods With reference to the international large-scale biobanks construction experience, and based on the standardization ideas of international organization for standardization and other institutions, a framework of standard for constructing CVD biobank in China was formulated. From the perspectives of multi-dimensions such as site facilities, equipment, operating procedures, data standard and information technology, technical requirements for constructing CVD biobank were put forward. Results According to the construction standards proposed in this article, the operation and quality management system of Tiantan Cerebrovascular Disease Biobank that is in line with international standard has been established, and a biobank resource platform for CVD clinical research, containing over 100 000 biological samples that can be collected, processed, and stored in standardized norms, has been built. Conclusions Tiantan Cerebrovascular Disease Biobank has a sufficient, diversity, and multipletime collection biological samples resource, and has realized standardized information storage, which can provide technical support for CVD precision medicine research on the docking of omics research, accurate screening, early warning, diagnosis and intervention of CVD.

Key words: Biobank; Cerebrovascular disease; Clinical research; Construction norm

林金嬉，梁宪红，李上智，刘丽，孟霞，王伊龙，王拥军. 脑血管病生物样本库建设标准研究[J]. 中国卒中杂志, 2021, 16(05): 449-456.

LIN Jin-Xi, LIANG Xian-Hong,LI Shang-Zhi, LIU Li, MENG Xia, WANG Yi-Long, WANG Yong-Jun. Research on Standard for Construction of Cerebrovascular Disease Biobank[J]. Chinese Journal of Stroke, 2021, 16(05): 449-456.

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