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作 者:周聪颖
机构地区:[1]苏州药明康德新药开发股份有限公司,苏州215104
出 处:《中国比较医学杂志》2016年第2期12-21,61,共11页Chinese Journal of Comparative Medicine
摘 要:"无特定病原菌(SPF)"名词意味着排除了对宿主致病的特定的病原菌清单。许多机构在使用活体动物开展生物医学研究时,考虑到许多不同的因素,包括动物来源、设施布局、微生物学背景、工程技术标准、运行实践和试验需要,倾向于制定机构层面的生物排除清单。同样地,机构层面的健康监测方案的设计和实施也根据需要有所不同。相比之下,中国的实验动物生产者和使用者受制于国标,国标中根据动物健康分类建立了国家层面生物排除清单,同时也规定了特定的动物健康等级对应的详细的动物房工程设计标准。此外,本文还汇总了北美主要的啮齿类供应商的SPF清单,来提示实验动物使用者在评估自己的实验大小鼠的生物排除清单和制定机构层面的健康监测方案时应该考虑不同的因素,来确保动物种群的健康和科学的完整性。The term "specific pathogen free" (SPF) implies the bioexclusion of a defined list of organisms that can cause disease in a host. Due to many different factors including animal source, vivarium layout, microbiological history, engineering standards, operation practice, and experimental needs, the bioexclusion list tends to be specific for many institutions using live animals in biomedical research. As such, the design and implementation of institution-specific health monitoring program can also vary based on needs. By comparison, laboratory animal producers and users in China are subject to GB regulations which have established a national bioexclusion list based on animal health categories, as well as set detailed engineering standards for vivarium operations based on specific animal health profiles. In addition to summarizing the SPF list of major rodent vendors in North America, the purpose of this article is to bring attention to the different factors animal users should take into consideration when evaluating one' s own bioexclusion list and designing institution-specific health monitoring program for laboratory mice and rats, in order to assure animal colony health and scientific integrity.
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