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支持生物医学研究的组织资源中的质量保证。

Quality Assurance in Tissue Resources Supporting Biomedical Research.

作者信息

Grizzle William E, Sexton Katherine C, Bell Walter C

机构信息

Department of Pathology, University of Alabama at Birmingham, Birmingham, AL.

出版信息

Cell Preserv Technol. 2008 Jul 30;6(2):113-118. doi: 10.1089/cpt.2008.9993..

Abstract

Modern biomedical research requires access to high quality specimens of human tissue with or without extensive clinical annotation. Multiple types of organizations have developed to supply human tissues to support biomedical research. These organizations follow different models including the specific models of 1) prospective collection, 2) tissue banking, and 3) tissue collection associated with clinical trials as well as the model of 4) a tissue resource that incorporates features of the other models. These types of organizations devoted to supplying tissues for research have chosen different goals to meet the different tissue and informational needs of the investigators to whom they supply tissue. In order to provide high quality tissues to support research, all models should rely on a strong quality assurance program with extensive quality control of the tissues being provided to support research. In addition to facilities which collect, process, store and provide tissues, the need for a rigorous QA program applies to all resources and infrastructures used to support biomedical research. The UAB Tissue Collection and Banking Facility which provides human tissue to support biomedical research has been functioning and developing since 1979. To our knowledge, similar programs in providing tissues from animals are less developed, but could easily follow the models which UAB and other institutions providing human tissues have established, including the approaches of UAB and others to QA and QC. This manuscript reviews the current concepts of QA and QC in use in organizations supplying tissue to support biomedical research as well as new approaches in QA and QC that have been proposed.

摘要

现代生物医学研究需要获取高质量的人体组织标本,这些标本可以带有或不带有详尽的临床注释。多种类型的组织已发展起来,以提供人体组织来支持生物医学研究。这些组织遵循不同的模式,包括以下特定模式:1)前瞻性采集;2)组织库;3)与临床试验相关的组织采集;以及4)整合了其他模式特征的组织资源模式。这些致力于为研究提供组织的组织类型,选择了不同的目标,以满足它们向其提供组织的研究人员的不同组织和信息需求。为了提供高质量的组织以支持研究,所有模式都应依赖一个强大的质量保证计划,对提供用于支持研究的组织进行广泛的质量控制。除了收集、处理、储存和提供组织的设施外,严格的质量保证计划的需求适用于所有用于支持生物医学研究的资源和基础设施。自1979年以来,阿拉巴马大学组织采集与储存设施一直在运作并不断发展,该设施提供人体组织以支持生物医学研究。据我们所知,提供动物组织的类似项目发展程度较低,但可以轻松遵循阿拉巴马大学和其他提供人体组织的机构所建立的模式,包括阿拉巴马大学和其他机构在质量保证和质量控制方面的方法。本手稿回顾了在为支持生物医学研究而提供组织的组织中目前使用的质量保证和质量控制概念,以及已提出的质量保证和质量控制的新方法。

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