PDF(Pubmed)
Abstract：
For handling safely infectious agents, European laboratories must comply with specific EC Directives, national regulations and recommendations from the World Health Organization (WHO). To prevent laboratory acquired infections (LAIs) and pathogens dissemination, a key biosafety rule requires that any infectious material (clinical specimens or research samples) manipulated outside a biosafety cabinet (BSC) must be inactivated unless the lack of infectivity is proven. This inactivation process is a crucial step for biosafety and must be guided by a rigorous experimental qualification and validation procedure. However, for diagnostic or research laboratories, this process is not harmonized with common standard operation procedures (SOPs) but based on individual risk assessment and general international guidelines which can pose problems in emergency situations such as major outbreaks or pandemics. This review focuses on viral inactivation method, outlining the current regulatory framework, its limitations and a number of ways in which biosafety can be improved.
摘要：
为了安全地处理传染性病原体，欧洲实验室必须遵守特定的EC指令，世界卫生组织（WHO）的国家法规和建议。为了防止实验室获得性感染（LAI）和病原体传播，一项关键的生物安全规则要求，除非证明缺乏传染性，否则在生物安全柜（BSC）外操作的任何感染性材料（临床标本或研究样品）都必须灭活。这种灭活过程是生物安全的关键步骤，必须以严格的实验鉴定和验证程序为指导。然而,用于诊断或研究实验室，此过程与通用标准操作程序（SOP）不协调，而是基于个人风险评估和一般国际准则，这些准则可能在重大疫情或大流行等紧急情况下造成问题。本文综述了病毒灭活方法,概述当前的监管框架，它的局限性以及可以改善生物安全性的许多方法。
