摘要
本标准涵盖了肾脏疾病生物样本库的管理和相关的操作规范。包括:伦理审批、行政许可报批和人员配备、样本采集前准备、样本采集、样本运送与交接、样本处理和分装、样本入库、样本的使用与共享、样本库巡检和应急预案、样本运输、样本销毁、样本库质量控制等。该标准尽可能详尽地描述每一个操作环节的规范,同时将样本库质量管理体系中的管理理念贯穿于技术操作过程中,以期帮助国内肾脏病单位生物样本库人员实现规范化管理和标准化操作。
The standard focuses on the management of renal biobank and technical specification of practice for bio-specimen of patients with kidney diseases,including ethical and administrative license approval,staffing,preparation for bio-specimen collection,bio-specimen collection,bio-specimen delivery and handover,bio-specimen processing and aliquot,bio-specimen storage,bio-specimen utilization and sharing,on-site inspection and emergence plans,bio-specimen transport,bio-specimen discard and quality control for biobank.It described each technical points in detailed and put the concept of quality management system throughout the practice process,in order to help renal biobank personnels to build up standardized management and operation.
作者
全国生物样本标准化技术委员会
肾脏病生物样本标准化工作组
刘志红
郑春霞
Renal Biospecimen Standardization Work Group of National Technical Committee on Biospecimen of Standardization Administration of China(National Clinical Research Center of Kidney Diseases,Jinling Hospital,Nanjing University School of Medicine,Nanjing 210016,China)
出处
《肾脏病与透析肾移植杂志》
CSCD
北大核心
2017年第4期355-359,共5页
Chinese Journal of Nephrology,Dialysis & Transplantation
关键词
生物样本库
管理
操作
规范
肾脏疾病
biobank
management
operation
specification
kidney diseases
