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生物样本库冷冻样本的质量控制新进展

Recent progress in quality management system of biobank frozen samples
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摘要 生物样本库作为基础研究成果向临床应用转化的平台,在疾病诊断、新药研发、疾病相关基因检测及流行病学研究中均有重要作用。对生物样本库全程进行质量管理和控制,制定标准化操作流程,收取临床资料及随访资料完整的患者血清、血浆、血细胞、组织等样本,并按照各自的标准化操作流程进行处理、分装、储存和使用。质量管理既是样本库建设的关键,也是样本库运转的中心环节,还是高质量规范化医学研究的基础保障。本文旨在探讨生物样本库冷冻样本质量管理体系的构建。 Biobank is the fundamental platform for translational research,it also plays a crucial role in disease diagnosis, newdrug development, disease-related gene detection and epidemiological studies. Biobank quality management system is the entire process of quality management and control,including standard operation procedure for processing,packaging,storage and use of serum,plasma,blood cells and tissue samples from patients with complete clinical and follow-up data. Quality management is essential for biobank operation and the guarantee for high quality and standardization of medical research. This article reviews the recent progress in establishment of quality management system for biobank frozen samples.
作者 嵇承栋 章佳英 于德华
机构地区 同济大学附属杨浦医院科研管理科
出处 《同济大学学报（医学版）》 CAS 2015年第6期133-136,140,共5页 Journal of Tongji University(Medical Science)
基金 上海市科学技术委员会科研项目(12692108700) 上海市卫生局面上科研项目(090092)
关键词 生物样本库 质量控制 冷冻样本 综述 biobank quality management frozen samples summarize
分类号 R446 [医药卫生—诊断学]
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参考文献13

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同济大学学报（医学版）
2015年 第6期

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