CAJ | 학술논문

目的：探讨临床生物样本库质量控制评估体系的建立。方法样本处理的质量控制，采用每个月随机抽检测方式，样本信息完整性与生物学活性质量控制采用先进行分组抽样再进行随机抽样的方法。结果对技术人员、样本处理和存储，样本信息完整性，样本生物学活性等方面进行质量控制评估，建立一套有效的、同行公认的样本质量控制评估体系。结论质量控制评估体系的建立在样本库的发展、样本在临床研究中的应用等方面，具有至关重要的作用。
목적：탐토림상생물양본고질량공제평고체계적건립。방법양본처리적질량공제，채용매개월수궤추검측방식，양본신식완정성여생물학활성질량공제채용선진행분조추양재진행수궤추양적방법。결과대기술인원、양본처리화존저，양본신식완정성，양본생물학활성등방면진행질량공제평고，건립일투유효적、동행공인적양본질량공제평고체계。결론질량공제평고체계적건립재양본고적발전、양본재림상연구중적응용등방면，구유지관중요적작용。
Objective To establish a quality control system for clinical biobank. Methods Random sampling method is used for speci-men treatment quality control,while random sampling and group sampling method is used for specimen information integrity and biological activity quality control. Results We managed the quality control of technicians,specimen treatment,specimen storage,information integrity and biologi-cal activity to establish an efficient quality control system for clinical biobank. Conclusion The establishment of quality control system has pro-found influence for specimen application in clinical research and development of biobank.