不明原因肝病生物样本库的建立与管理

Establishment and management of biobank for unknown etiology liver disease

目的探讨不明原因肝病生物样本库的建立方法、相关数据信息的管理方法以及对存储样本的质量控制技术。方法收集2018年7月至2019年6月于南京中医药大学附属南京医院(南京市第二医院)肝病科以不明原因肝病为主要诊断的住院患者,留取血浆、白膜层以及外周血单个核细胞(PBMC)。分别对每个样本进行编码,然后将血浆和白膜层样本置于-80℃超低温冰箱冷冻保存,PBMC样本置于液氮罐保存。生物样本库专职人员登录南京市多中心生物样本库系统录入样本捐献者的临床信息和样本的编码信息。定期随机抽取样本,进行DNA、RNA提取和质量检测。结果截至2019年6月,不明原因肝病生物样本库共收集了2007份样本,其中血浆样本1625份,白膜层样本333份,PBMC样本49份。随机抽样检测5例白膜层样本,所有受检样本核酸无明显降解,检测结果符合样本质量标准,能够满足后续实验需求。结论初步建立了不明原因肝病生物样本库,制定了标准化的样本库运行和管理规章制度,为不明原因肝病的进一步研究提供实验样本和详细的临床资料。

Objective To explore the construction method of biobank,sample data management and quality control of stored samples.Methods Plasma,buffy coat and peripheral blood mononuclear cells(PBMC)samples from patients who were diagnosed as unknown etiology liver disease during July 2018 and June 2019 in the Second Hospital of Nanjing,Nanjing University of Chinese Medicine were harvested,coded and stored in-80℃refrigerator or liquid nitrogen.The full-time staff of the biobank log in the system of Nanjing multi center biological sample database to input the clinical information and sample coding information of the donors.Samples were randomly selected for the extraction and identification of DNA and RNA.Results Up to June 2019,a total of 2007 samples were collected,including 1625 plasma samples,333 buffy coat samples and 49 PBMCs samples.In addition,the quality of DNA and RNA of 5 buffy coat samples were detected.All random samples were in accordance with the quality standards of samples and could meet the requirements of the following studies.Conclusion A biobank of unknown etiology liver disease and standardized biobank operation and management procedures were established,which can provide experimental samples and detailed clinical data for further study of unknown etiology liver disease.