我国生物样本库与病原微生物菌(毒)种保藏机构异同分析

Analysis of similarities and differences between biological sample banks and pathogenic microorgnism strain collective organization in China

目的了解我国生物样本库与病原微生物菌(毒)种保藏机构[菌(毒)种保藏中心]的异同点。方法通过研读国家资源保藏管理标准、条例、管理办法及相关文献等方法,全面获取生物样本库与菌(毒)种保藏中心相关内容,从建设参考标准、技术规范、执行条例、保藏内容、经费来源、人员管理、伦理及知情同意等方面分析两种保藏机构的相同点和不同点。结果两种保藏机构的相同点有:都是独立法人单位,有完备的管理体系文件,有信息化软件对保藏实物进行出入库管理,具备专业的冷链设备,涉及生物安全和信息安全。不同点有:在保藏资格审批、保藏主体、执行依据和标准、经费来源、用途、保藏内容及特点、人员管理、安全保障、伦理和知情同意等方面有较大差别。结论国家日益重视生物资源管理,我国保藏机构逐步迈向标准化时代。生物样本库主要建设在医院内,在共享使用及转化方面优于菌(毒)种保藏机构,菌(毒)种保藏机构主要建设在科研事业单位,使用转化较慢,需要加快共享机制建设。

Objective To understand the similarities and differences between the biological sample banks and pathogenic microorgnism strain collective organization.Methods By studying national resource preservation management standards,regulations,methods,and relevant literature,relevant content of biological sample banks and pathogenic microorgnism strain collective organization were comprehensively obtained,and the similarities and dfferences were analyzed between the biological sample banks and pathogenic microorgnism strain collective organization,including construction reference standards,technical specifications,implementation regulations,preservation content,source of funds,personnel management,ethics and informed consent.Results The similarities between the two types of preservation institutions:both are independent legal entities,have complete management system documents,have information software to manage the entry and exit of preserved physical objects,have professional cold chain equipment,and involve biosafety and information security.The differences include significant differences in the approval of preservation qualifications,preservation objects,execution basis and standards,funding sources,purposes,preservation content and characteristics,personnel management,safety assurance,ethics,and informed consent.Conclusions Our country pays more and more attention to the management of biological resources,and are moving towards a standardized era.The biological sample banks are mainly built in hospitals,which is superior to bacterial(virus)species preservation institutions in terms of shared use and transformation.Microorgnism strain collective organizations mainly built in scientific research institutions,and the use and transformation are slow.Therefore,it is necessary to accelerate the construction of sharing mechanisms.