摘要
目的对4种药品微生物快速鉴定技术的鉴定结果进行比较分析,建立一种用于药品微生物鉴定技术的评价方法。方法以19株标准菌株和10株野生菌株为参考,分别采用API微生物鉴定系统、VITEK 2 Compact全自动微生物鉴定系统、RiboPrinter全自动微生物基因指纹鉴定系统和MicroSeq ID DNA测序系统对其进行不少于50次的鉴定,计算各鉴定方法在属水平和种水平上的准确性及重现性。结果 4种鉴定技术均可用于药品控制菌的鉴定,在非控制菌中存在明显差异,分子生物学技术的准确性和重现性均优于生化鉴定技术。结论实验室应对微生物鉴定系统进行确认,谨慎评价所用方法及其使用范围。
OBJECTIVE To establish a evaluation method of microbial identification technology by comparing four different micro- bial identification methods. METHODS A total of 50 tests by API microbial identification system, VITEK 2 compact system, Ribo- printer systenl, and MicroSeq ID DNA sequencing system were performed against 19 standard strains and 10 wild strains. The accuracy and reproducibility of these methods were evaluated. RESULTS All the four identification technologies could be used to identify specified micro-organisms, but they had difference in other strains. Molecular bioteehnology was better than biochemical identification in accuracy and reproducibility. CONCLUSION The users should establish suitable acceptance criteria for accuracy and reproduc- ibility, taking into account method capability.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2016年第22期1967-1971,共5页
Chinese Pharmaceutical Journal
基金
中国药典标准提高研究项目(1200)
关键词
生化鉴定
分子生物学
准确性
重现性
一致性评价
biochemical identification
molecular biotechnology
accuracy
reproducibility
cossistency evaluation
