判断无菌检查阳性结果有效性的实验探讨

目的:探讨通过有效的实验手段帮助判断无菌检查阳性结果检出菌的来源,进而更客观地判断检验结果的有效性。方法:采用显微镜镜检、细菌鉴定、细菌 FTIR 相似性分析等方法,结合实验人员对进场、清场、检查等实验过程的回顾综合判断。结果:可以帮助实验人员发现实验过程中可能的不合理环节,判断实验检出菌的来源。结论:有助于客观地确定无菌检查阳性结果的有效性。

Discuss on judging the validity of the positive result in sterility test

Objective:Discuss to confirm the origin of bacterium from positive inoculum in sterility test with some effective methods,and judge the validity of the positive result in sterility test impersonally.Methods:Sum up micro- scope examination of bacteria,identification of bacteria by Pheonix~(TM) 100 (BD),correlation investigation of bacteria by FTIR,as well as the operator looked back the process about passing in and out the area of sterility test and the operation during the test,etc.Results:These methods are helpful to judge the origin of bacterium and detect some illogical steps among the sterility test.Conclusion:By this way it is redounded to judge the validity of the positive result in sterility test impersonally.