| 张育军,高芳芳,彭卫康,叶磊,徐涛,刘玉兰.生物样本库质量控制体系建立的经验和体会[J].转化医学杂志,2014,3(3):170-173,188 |
| 生物样本库质量控制体系建立的经验和体会 |
| The experience to set up a quality contrd system for biobank |
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| DOI： |
| 中文关键词: 质量控制 质量管理 标准化操作流程 信息化管理 |
| 英文关键词:Quality control Quality management Standard operation procedure Information management |
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| 中文摘要: |
| 目的探讨生物样本库样本质量管理体系的建立。方法进行生物样本库资源管理，制定样本标准化操作流程，收取临床资料及随访资料完整的患者的组织、血清、血浆、血细胞、骨髓细胞等样本，并按照各自的标准化操作流程进行处理、分装、储存和使用，全程进行质量管理和控制。应用数据管理系统软件进行入库和管理。结果自2012年1月，北京大学人民医院已有25个科室的样本入库，已入库样本63 693例、病种33种、样本类型20种。根据样本使用人员的反馈及样本的质量检测均表明样本质量较好。结论质量管理是样本库运转的中心环节，是样本库建设的关键，是高质量规范化医学研究的基础保障。 |
| 英文摘要: |
| ObjectiveTo establish a biosample quality management system of biobank. MethodsWe pursue the biobank resource management, make the standard operation procedure of biosample, collect serum, plasma, blood cells, bone marrow samples of the patients who have the complete clinical and follow up data and in accordance with the respective standard operation procedure for processing,packaging, storage and use, the entire process quality management and control.Application of data management system software for storage and management. ResultsSince Jan 2012, The biobank of People′s Hospital in Peking University has stored biosamples by 25 clinical departments with 63 693 cases of biosamples, more than 33 kinds of diseases, 20 types of samples. According to the quality detection and feedback from user, It showed that the biosample quality is high. ConclusionQuality management is the central part of operating a biobank and the basic guarantee for high quality and standardization of medical research. |
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