支持生物医学研究的组织资源质量保证。

William E Grizzle, Katherine C Sexton, Walter C Bell
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引用次数: 0

摘要

现代生物医学研究需要获得高质量的人体组织标本,有或没有广泛的临床注释。多种类型的组织已经发展为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型,包括1)前瞻性收集的特定模型,2)组织库,3)与临床试验相关的组织收集,以及4)结合其他模型特征的组织资源模型。这些致力于为研究提供组织的组织选择了不同的目标,以满足他们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来支持研究,所有模型都应该依赖于强有力的质量保证计划,对所提供的组织进行广泛的质量控制,以支持研究。除了收集、处理、储存和提供组织的设施外,严格的质量保证程序也适用于用于支持生物医学研究的所有资源和基础设施。自1979年以来,UAB组织收集和银行设施一直在运作和发展,为生物医学研究提供人体组织支持。据我们所知,提供动物组织的类似项目还不太发达,但可以很容易地遵循UAB和其他机构提供人体组织的模式,包括UAB和其他机构的QA和QC方法。本文回顾了目前在组织中使用的QA和QC概念,以支持生物医学研究,以及已经提出的QA和QC新方法。
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Quality Assurance in Tissue Resources Supporting Biomedical Research.

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.

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