分枝杆菌菌株库建设模式与实践研究

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。

A STUDY ON PATTERN AND PRACTICE OF CONSTRUCTING MYCOBACTERIA CULTURE COLLECTION

Objective To construct mycobacteria culture collection which should be of having bio-safety assurance,rich and diverse in strains collection,plentiful in strain data including biological traits and corresponding case information,clear and facilitated in operation procedure and convenient in resource sharing in order to provide a basic platform for clinical diagnosis,treatment and science research of tuberculosis.Methods Bio-safety assurance system of Mycobacteria culture collection was constructed mainly according to demands of BSL-2 laboratory management and regulations including China Medical Culture Collection Regulations and List of Human Transmission of Pathogenic Microorganisms.The contents and extensions of Mycobacteria culture collection were established according to its function and the latest achievements and trend of future development in clinical diagnosis,treatment and science research of tuberculosis.The processes,in which strain data containing biological traits and corresponding case information were collected and information database was built,were set up respectively by the difference of collection channel of the strain which was the clinical isolates or the special strains on the special study project.The information system of Mycobacteria culture collection was founded by applying network communication and database technology to advance our work efficiency and provide convenient services of resource sharing.Results(1) Bio-safety assurance system of Mycobacteria culture collection comprised bio-safety lead agency,bio-safety standard of experimental techniques,laboratory bio-safety management and protection,and culture collection bio-safety management.(2) Construction of Mycobacteria culture collection included three major part: strains preservation bank,strains databases containing biological traits and corresponding case information and the information system of Mycobacteria culture collection.Time span of strain data collection for per preservation strain was from the time of patient′s seeing a doctor to the end of a therapy period and the save cycle of preservation strain was 10 years.(3) For the clinical isolates,the processes of data collection and information database included a few important step by time series as following: temporary storage outside the Mycobacteria culture collection,strain data′s entry,clinical case data′s entry,judging the strain′s value,preservation of strain,accessing of specific strain,complement entry of scientific research information,and so on.For the special strains,the processes of data collection and information database abide by the specific requirement of the special study project.(4) The information system of Mycobacteria culture collection was developed and programmed based on C/S architecture by using SQL SERVER and Delphi7 as development tools.It included five subsystem named preservation management,quality control management,document management,resource management and system management.Conclusion For construction of Mycobacteria culture collection,bio-safety assurance is the premise;plentiful content is the center;a reasonable process is the key;the information system development is the foundation.