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目的建立生物安全保证、菌种资源丰富、相应资料齐全、操作流程顺畅、资源共享便捷的分枝杆菌菌株库,为结核病临床诊疗与科学研究提供基础性平台。方法主要依照二级生物安全(BSL-2)实验室管理要求和“中国医学微生物菌种保藏管理办法”、“人间传染的病原微生物名录”等法规构建分枝杆菌菌株库生物安全保证体系;根据菌株库的功能作用结合结核病临床诊疗与科学研究的最新成就及未来发展要求确立分枝杆菌菌株库建设的内涵与外延;以临床分离菌株、专项研究收集菌株为操作对象制定适宜的菌株资料、相应病例资料收集及信息库建设流程;采用网络通讯和数据库技术建立分枝杆菌菌株库信息系统以提高建库工作效率和提供便捷的资源共享服务。结果①构建了包括生物安全管理领导机构、实验技术生物安全水平标准、实验室生物安全管理与防护、菌株库生物安全管理等在内的分枝杆菌菌株库生物安全保证体系;②分枝杆菌菌株库包括菌株保存库、菌株资料库及相应病例资料库、菌株库信息系统三大主要部分,保存菌株的资料收集以相应的1个治疗周期为界限,菌株保存周期为10年;③临床分离菌株的菌株资料、相应病例资料收集及信息库建设流程按时间序列包括收集菌株库外暂存、菌株资料录入、病例资料录入、菌株保存价值判定、菌株入库保存、特定菌株取用及研究信息补充录入等重大步骤,专项研究收集菌株则按其特定的要求建立相应的工作流程;④采用SQL SERVER大型数据库和Delphi7开发工具开发了基于C/S体系结构包含保藏管理、质控管理、文档管理、资源管理、系统管理等五大子系统的分枝杆菌菌株库信息系统。结论在分枝杆菌菌株库建设中,生物安全保证是前提、丰富内涵建设是中心、合理流程设置是关键、信息系统开发是基础。
OBJECTIVE To establish a strain of mycobacterial strain that has a bio-safety guarantee, rich bacteria resources, complete corresponding data, smooth operation procedure and convenient resource sharing, which provides a basic platform for clinical diagnosis and scientific research of tuberculosis. Methods The biosafety of mycobacterial strain bank was constructed mainly according to the requirements of the BSL-2 laboratory management and the regulations of the “Regulations of the PRC on the Preservation and Storage of Medical Microbial Species” and the “List of Pathogenic Micro-organisms Containing Human Infectious Diseases” Assurance system; According to the function of strain pool combined with the latest achievements of clinical diagnosis and treatment of tuberculosis and scientific research requirements and the future development of the establishment of the connotation and extension of mycobacterial strain library construction; clinical isolates, special collection of strains for the operation object to develop appropriate Strain data, the corresponding case data collection and information base construction process; the use of network communication and database technology to establish mycobacterial strain database system to improve the efficiency of database construction and provide convenient resource sharing services. Results ① The biological safety guarantee system of mycobacteria strain bank was established including the leading body of biological safety management, the standard of biosafety in experimental techniques, the management and protection of biological safety in laboratory, and the biological safety management of strain bank. The database includes three main parts: the strain database, the strain database, the corresponding case database and the strain database. The data of the stored strains are collected with the corresponding period of one treatment cycle, and the strain preservation period is 10 years. The clinical isolates The corresponding case data collection and information base construction process include time-series collection of strain outside the database, data entry of the strain, case data entry, determination of the strain preservation value, storage of the strain in storage, access to specific strains and research information Entry and other major steps, the special collection of strains according to their specific requirements to establish the corresponding workflow; ④ using SQL SERVER large database and Delphi7 development tools based on the C / S architecture including preservation management, quality control management, document management, Resource management, system management, and other five subsystems branching rod Strain library information system. Conclusion In the construction of mycobacterial strain bank, the assurance of biological safety is the premise and the construction of rich connotation is the center. The rational process setting is the key and the development of information system is the foundation.