CAJ | 학술논문

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63693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。
목적：탐토생물양본고양본질량관리체계적건립。방법진행생물양본고자원관리，제정양본표준화조작류정，수취림상자료급수방자료완정적환자적조직、혈청、혈장、혈세포、골수세포등양본，병안조각자적표준화조작류정진행처리、분장、저존화사용，전정진행질량관리화공제。응용수거관리계통연건진행입고화관리。결과자2012년1월，북경대학인민의원이유25개과실적양본입고，이입고양본63693례、병충33충、양본류형20충。근거양본사용인원적반궤급양본적질량검측균표명양본질량교호。결론질량관리시양본고운전적중심배절，시양본고건설적관건，시고질량규범화의학연구적기출보장。
Objective To establish a biosample quality management system of biobank . Methods We 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 proce -dure for processing,packaging, storage and use, the entire process quality management and control . Application of data management system software for storage and management .Results Since 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.Conclusion Quality management is the central part of operating a biobank and the basic guarantee for high quality and standardization of medical research .