目的:了解国内疾控系统生物安全三级实验室(以下简称“BSL-3实验室”)关键生物安全防护设备的使用现况,为推进国内高等级生物安全实验室关键生物安全防护设备的研发与应用提供参考。方法:利用中国疾控中心流行病学动态数据采集(epidemio...目的:了解国内疾控系统生物安全三级实验室(以下简称“BSL-3实验室”)关键生物安全防护设备的使用现况,为推进国内高等级生物安全实验室关键生物安全防护设备的研发与应用提供参考。方法:利用中国疾控中心流行病学动态数据采集(epidemiological dynamic data collection,EDDC)平台在网上填报、收集信息,运用描述性研究的方法分析生物安全柜、气(汽)体消毒装置、压力蒸汽灭菌器和生物安全型高效空气过滤装置4种设备的品牌、国产/进口占比、使用类型、价格等现况。结果:国内疾控系统BSL-3实验室中生物安全柜、气(汽)体消毒装置和压力蒸汽灭菌器的进口率高于国产率,生物安全型高效空气过滤装置国产化程度较高,各类设备的品牌呈多样化。结论:建议国家和地方管理部门加大对国产产品的扶持力度,鼓励相关企业自主研发实验室关键生物安全防护设备,提升国内实验室设施、设备技术质量,实现由进口为主向自主保障的转变。展开更多
Worldwide,public health systems are continually challenged by emerging and re-emerging viruses.It is therefore important that high-containment labs coordinate and communicate globally to share their experiences and le...Worldwide,public health systems are continually challenged by emerging and re-emerging viruses.It is therefore important that high-containment labs coordinate and communicate globally to share their experiences and lessons to improve their capacity to respond to threats.The National Biosafety(Level 4)Laboratory in Wuhan,CAS,which is the first Level 4 biosafety laboratory(BSL-4)in China,has been certified recently and it is expected to play an important role in the prevention and control of highly infectious agents in future.Trained and experienced staff in such organizations is the most important factor contributing to safety and security.Therefore,it is imperative to develop a standard training program.Accordingly,in the present study,we developed an improved training program and assessment system based on policies and practices developed by BSL-3/4s in other countries.It included the following three components:(1)A flexible modularized theoretical training:This training comprised 14 modularized theoretical topics such that staffs with different backgrounds could take this theoretical training with different topic combinations according to their knowledge and skill levels;(2)A standardized practical training assessment:This comprehensive assessment,which could be used with biosafety laboratory staff before,during,and after training,included standard operation procedures to meet the special requirements of trainees with different scores;and(3)An applicable documentation system:A certification system was established to evaluate the ability of all staff working inside or outside the laboratory,implemented by a special committee.This certification was approved and authorized by the director of the laboratory and was classified into three grades with corresponding minimal requirements.Further,the present study examined the importance of and need for networking for training BSL-3/4 staff.The establishment of rigorous standards for training BSL-3/4 staff will instill confidence in the public,policy makers,and security officials.Additionally,the expanded international network of BSL-3/4s will continue to be operated safely and will pose no risk to scientific staff,local communities,surrounding environment,and host nations.The clarification and coordination of training standards will help develop a highly-qualified biocontainment workforce and will result in a series of programs that will enable scientists to develop measures to deal with existing threat agents and new diseases that emerge.展开更多
面对突发疫情,生物安全三级(biosafety level 3,BSL-3)实验室是否能及时启动并稳定、安全运行,为科研攻关提供安全、可靠的技术平台,是对实验室应急能力的考验。针对2019冠状病毒病疫情,复旦大学BSL-3实验室紧急启动开展冠状病毒实验的...面对突发疫情,生物安全三级(biosafety level 3,BSL-3)实验室是否能及时启动并稳定、安全运行,为科研攻关提供安全、可靠的技术平台,是对实验室应急能力的考验。针对2019冠状病毒病疫情,复旦大学BSL-3实验室紧急启动开展冠状病毒实验的申请流程。经国家合格评定认可委员会(China National Accreditation Service for Conformity Assessment,CNAS)和国家卫生健康委员会批准,实验室在开展实验1周内即从来自上海患者标本中分离到新型冠状病毒毒株,体现了平时实验室内涵建设的重要性。BSL-3实验室的内涵建设包括实验室风险评估及管理、不同人员针对性培训、设施和设备管理等生物安全管理体系的建设。本文介绍复旦大学BSL-3实验室在应急能力及内涵建设方面的经验和体会,期望对BSL-3实验室的建设和管理提供参考。展开更多
文摘目的:了解国内疾控系统生物安全三级实验室(以下简称“BSL-3实验室”)关键生物安全防护设备的使用现况,为推进国内高等级生物安全实验室关键生物安全防护设备的研发与应用提供参考。方法:利用中国疾控中心流行病学动态数据采集(epidemiological dynamic data collection,EDDC)平台在网上填报、收集信息,运用描述性研究的方法分析生物安全柜、气(汽)体消毒装置、压力蒸汽灭菌器和生物安全型高效空气过滤装置4种设备的品牌、国产/进口占比、使用类型、价格等现况。结果:国内疾控系统BSL-3实验室中生物安全柜、气(汽)体消毒装置和压力蒸汽灭菌器的进口率高于国产率,生物安全型高效空气过滤装置国产化程度较高,各类设备的品牌呈多样化。结论:建议国家和地方管理部门加大对国产产品的扶持力度,鼓励相关企业自主研发实验室关键生物安全防护设备,提升国内实验室设施、设备技术质量,实现由进口为主向自主保障的转变。
基金This work was supported by the National Key Research and Development Program of China(2016YFC1202203).
文摘Worldwide,public health systems are continually challenged by emerging and re-emerging viruses.It is therefore important that high-containment labs coordinate and communicate globally to share their experiences and lessons to improve their capacity to respond to threats.The National Biosafety(Level 4)Laboratory in Wuhan,CAS,which is the first Level 4 biosafety laboratory(BSL-4)in China,has been certified recently and it is expected to play an important role in the prevention and control of highly infectious agents in future.Trained and experienced staff in such organizations is the most important factor contributing to safety and security.Therefore,it is imperative to develop a standard training program.Accordingly,in the present study,we developed an improved training program and assessment system based on policies and practices developed by BSL-3/4s in other countries.It included the following three components:(1)A flexible modularized theoretical training:This training comprised 14 modularized theoretical topics such that staffs with different backgrounds could take this theoretical training with different topic combinations according to their knowledge and skill levels;(2)A standardized practical training assessment:This comprehensive assessment,which could be used with biosafety laboratory staff before,during,and after training,included standard operation procedures to meet the special requirements of trainees with different scores;and(3)An applicable documentation system:A certification system was established to evaluate the ability of all staff working inside or outside the laboratory,implemented by a special committee.This certification was approved and authorized by the director of the laboratory and was classified into three grades with corresponding minimal requirements.Further,the present study examined the importance of and need for networking for training BSL-3/4 staff.The establishment of rigorous standards for training BSL-3/4 staff will instill confidence in the public,policy makers,and security officials.Additionally,the expanded international network of BSL-3/4s will continue to be operated safely and will pose no risk to scientific staff,local communities,surrounding environment,and host nations.The clarification and coordination of training standards will help develop a highly-qualified biocontainment workforce and will result in a series of programs that will enable scientists to develop measures to deal with existing threat agents and new diseases that emerge.
文摘面对突发疫情,生物安全三级(biosafety level 3,BSL-3)实验室是否能及时启动并稳定、安全运行,为科研攻关提供安全、可靠的技术平台,是对实验室应急能力的考验。针对2019冠状病毒病疫情,复旦大学BSL-3实验室紧急启动开展冠状病毒实验的申请流程。经国家合格评定认可委员会(China National Accreditation Service for Conformity Assessment,CNAS)和国家卫生健康委员会批准,实验室在开展实验1周内即从来自上海患者标本中分离到新型冠状病毒毒株,体现了平时实验室内涵建设的重要性。BSL-3实验室的内涵建设包括实验室风险评估及管理、不同人员针对性培训、设施和设备管理等生物安全管理体系的建设。本文介绍复旦大学BSL-3实验室在应急能力及内涵建设方面的经验和体会,期望对BSL-3实验室的建设和管理提供参考。
