基于ISO20387样本库质量控制之人员比对分析  

A Personnel Comparative Analysis of Quality Control Based on ISO20387 Sample Library

作　　者：刘丽[1,2] 王梦星 林金嬉 梁宪红[1,2] 乔琳 李上智[1,2] 佟玲 秦海强[1,3] LIU Li;WANG Mengxing;LIN Jinxi;LIANG Xianhong;QIAO Lin;LI Shangzhi;TONG Ling;QIN Haiqiang(Beijing Tiantan Hospital,Capital Medical University,Beijing 100070,China;National Clinical Research Center forNeurological Diseases,Beijing 100070,China;Department of Neurology of Beijing Tiantan Hospital,Capital Medical University,Beijing 100070,China)

机构地区：[1]首都医科大学附属北京天坛医院,北京100070 [2]国家神经系统疾病临床医学研究中心,北京100070 [3]首都医科大学附属北京天坛医院神经病学中心,北京100070

出　　处：《标记免疫分析与临床》2023年第2期352-356,共5页Labeled Immunoassays and Clinical Medicine

基　　金：国家自然科学基金资助项目(编号:82271299,81870907);首都临床特色诊疗技术研究及转化应用(编号:Z221100007422051);“十三五”国家重点研发计划项目(编号:2016YFC1301604)。

摘　　要：目的基于ISO20387生物样本库通用要求,通过不同工作年限的技术人员同时进行DNA提取实验,探索通过人员比对方法对样本库人员进行能力评估。方法样本库3位不同工作年限的技术人员使用相同样本设备试剂进行DNA提取,全过程严格遵循操作规程,对DNA得率进行分析,使用Qubit对完整性进行评价。结果3位不同操作人员提取的DNA得率和Qubit结果有明显差别,日常工作人员与技术主管操作无差异,新加入实验室人员与技术主管有明显差异。结论人员操作对样本质量有明显影响,人员比对作为实验室质量保证的途径之一,方法较为灵活、简便,可用于样本库人员能力评估,通过人员能力评估可以及时发现人员操作是否合格,保证生物样本处理的质量。Objective Based on the general requirements of ISO20387 biobank,DNA extraction experiments were carried out by technicians with different working years simultaneously to compare the ability assessment of sample database personnel.Methods Three technicians with different working years in the sample library used the same sample equipment reagent for DNA extraction,and the whole process strictly followed the operating procedures.The DNA yield was analyzed,and the integrity was evaluated by Qubit.Results There were significant differences in the DNA yield and Qubit results among the three different operators.There was no difference in the operation between the daily staff and the technical supervisor,and there was significant difference between the newly joined laboratory staff and the technical supervisor.Conclusion Personnel comparison,as one of approaches of laboratory quality assurance,is flexible and simple.It can be used for personnel ability assessment in the sample library.Through personnel ability assessment,evaluation can be conducted for whether personnel operation is qualified in time,and ensure the quality of biological sample processing.

关 键 词：质量管理 ISO20387 人员比对 

分 类 号：R-331[医药卫生]