四种药品微生物快速鉴定技术的方法学一致性评价

来源 :中国药学杂志 | 被引量 : 0次 | 上传用户:zxzwo
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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 compare and appraise the identification results of four kinds of rapid identification technology of pharmaceutical drugs and establish a method of evaluation for the identification of pharmaceutical microorganisms. Methods A total of 19 strains of standard strains and 10 strains of wild strains were used as reference. The API microbe identification system, the VITEK 2 Compact automatic identification system, the RiboPrinter automatic microbe gene fingerprint identification system and the MicroSeq ID DNA sequencing system were used for reference. 50 times the identification of each method to determine the level of identification and species level accuracy and reproducibility. Results All the four identification techniques could be used for the identification of drug control bacteria. There were obvious differences in non-control bacteria. The accuracy and reproducibility of molecular biology techniques were better than those of biochemical identification techniques. Conclusion The laboratory should confirm the microbial identification system and carefully evaluate the method used and its scope of use.
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