无菌检查阳性结果的确认  

Confirmation of positive results of sterility test

作　　者：肖建光[1] 欧国栋 林铁豪[1] XIAO Jianguang;OU Guodong;LIN Tiehao(Guangdong Institute of Drug Control,Guangzhou 510663,China)

机构地区：[1]广东省药品检验所,广州510663

出　　处：《中国药品标准》2021年第3期265-269,共5页Drug Standards of China

摘　　要：目的:对一例无菌检查阳性结果的样品,进行回顾分析并确认,确证检验结果的真实性和可靠性。方法:采用VITEK2 Compact多相分类鉴定技术、全自动快速微生物质谱等方法对检出菌进行鉴定、溯源分析。结果:结合实验过程的回顾性判断,确证无菌检查阳性结果来源于样品。结论:实验室对出现阳性结果的分析调查和确认方案,对检验结果的科学有效性具有重要的指导意义。Objective:A sample with positive result of sterility test was retrospectively analyzed and confirmed to verify the authenticity and reliability of the test result.Methods:VITEK2 compact multiphase classification and identification technology,automatic rapid microbial mass spectrometry and other methods were used to identify and trace the detected bacteria.Results:It was confirmed that the positive results of sterility test came from the samples in combination with the retrospective judgment of the experimental process.Conclusion:The analysis,investigation and confirmation of positive results in the laboratory have important guiding significance for the scientific validity of the test results.

关 键 词：无菌检查 阳性分析 鉴定 结果确证 

分 类 号：R921.2[医药卫生—药学]