生物安全实验室病毒悬液灭活试验方法标准转化研究

Transformation and standardization of the inactivation test method for virus suspension in biosafety laboratory

化学消毒剂常用于病毒的灭活和实验室环境的消毒,其对病毒灭活的效果及评价直接影响实验室的生物安全。鉴于目前我国尚缺乏对化学消毒剂杀病毒效果的评价标准,本文在对欧盟现行的化学消毒剂杀病毒定量悬浮试验标准的研究分析的基础上,结合我国生物安全实验室的管理现状,提出了欧盟现行标准转化的方案。建议以包括高致病性病毒的替代病毒在内的6种病毒作为试验用的模式病毒,同时增加残留化学消毒剂的去除方法和试验结果 95%置信区间计算方法内容。该建议提高了标准的科学性和可操作性,并为我国实验室消毒灭菌标准制定提供了参考。

Chemical disinfectants are generally used for virus inactivation and environment disinfection in biosafety laboratory, and the efficacy and evaluation of the disinfection are critical to ensure the laboratory biosafety. However, there is a current lack of applied standard to evaluate the virucidal efficacy of chemical disinfectants in our e6untry. In this paper, a European Union standard ＂Method and Requirements of Virucidal Quantitative Suspension Test Method for Chemical Disinfectants Used in Human Medicine＂ was analyzed and a standard transformation scheme has been proposed. It is suggested that the model viruses should be increased from 3 to 6, including the surrogate viruses to substitute highly pathogenic viruses, and that the method to remove the residual chemical disinfectant and the calculation of 95 % confidence interval should be incorporated into the standard. The suggestion will improve the scientific and operational standards related to disinfection and sterilization in biosafety laboratory in China.