四种药品微生物快速鉴定技术的方法学一致性评价

杨燕, 蒋波, 鲍英, 徐伟东, 钟玮, 李芳, 范一灵, 冯震, 杨美成

中国药学杂志 ›› 2016, Vol. 51 ›› Issue (22) : 1967-1971.

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中国药学杂志 ›› 2016, Vol. 51 ›› Issue (22) : 1967-1971. DOI: 10.11669/cpj.2016.22.016
论著

四种药品微生物快速鉴定技术的方法学一致性评价

  • 杨燕, 蒋波, 鲍英, 徐伟东, 钟玮, 李芳, 范一灵, 冯震, 杨美成*
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Evaluation of Four Kinds of Rapid Identification Technologies of Microbials in Pharmaceutical Products

  • YANG Yan, JIANG Bo, BAO Ying, XU Wei-dong, ZHONG Wei, LI Fang, FAN Yi-ling, FENG Zhen, YANG Mei-cheng
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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。

Abstract

OBJECTIVE To establish a evaluation method of microbial identification technology by comparing four different microbial identification METHODS. METHODS A total of 50 tests by API microbial identification system, VITEK 2 compact system, Riboprinter system, 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 biotechnology was better than biochemical identification in accuracy and reproducibility. CONCLUSION The users should establish suitable acceptance criteria for accuracy and reproducibility, taking into account method capability.

关键词

生化鉴定 / 分子生物学 / 准确性 / 重现性 / 一致性评价

Key words

biochemical identification / molecular biotechnology / accuracy / reproducibility / cossistency evaluation

引用本文

导出引用
杨燕, 蒋波, 鲍英, 徐伟东, 钟玮, 李芳, 范一灵, 冯震, 杨美成. 四种药品微生物快速鉴定技术的方法学一致性评价[J]. 中国药学杂志, 2016, 51(22): 1967-1971 https://doi.org/10.11669/cpj.2016.22.016
YANG Yan, JIANG Bo, BAO Ying, XU Wei-dong, ZHONG Wei, LI Fang, FAN Yi-ling, FENG Zhen, YANG Mei-cheng. Evaluation of Four Kinds of Rapid Identification Technologies of Microbials in Pharmaceutical Products[J]. Chinese Pharmaceutical Journal, 2016, 51(22): 1967-1971 https://doi.org/10.11669/cpj.2016.22.016
中图分类号: R917   

参考文献

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基金

中国药典标准提高研究项目(1200)
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