文章摘要
余萌,王似锦,马仕洪.洋葱伯克霍尔德菌群(Bcc)的分类鉴定研究进展[J].中国药事,2022,36(7):758-771
洋葱伯克霍尔德菌群(Bcc)的分类鉴定研究进展
Advances in Taxonomy and Identifi cation of Burkholderia cepacia Complex
  
DOI:10.16153/j.1002-7777.2022.07.004
中文关键词: 洋葱伯克霍尔德菌群  鉴定策略  16S rRNA  看家基因  基因分型
英文关键词: Burkholderia cepacia Complex  identifi cation catergory  16S rRNA  housekeeping gene  genotyping
基金项目:
作者单位
余萌 中国食品药品检定研究院,国家药品监督管理局化学药品质量研究与评价重点实验室,北京 100050 
王似锦 中国食品药品检定研究院,国家药品监督管理局化学药品质量研究与评价重点实验室,北京 100050 
马仕洪 中国食品药品检定研究院,国家药品监督管理局化学药品质量研究与评价重点实验室,北京 100050 
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中文摘要:
      目的:探讨适用于药品微生物控制中的洋葱伯克霍尔德菌群(Bcc)的鉴定策略。方法:结合药品微生物控制中对Bcc的鉴定和分型需求,对目前应用较为广泛的微生物鉴定技术的特点和鉴定或分型能力进行阐述和讨论,提供满足不同鉴定水平要求的鉴定策略。结果:对于Bcc,不同的鉴定方法能达到的鉴定水平存在差异。手动/自动化的生化鉴定系统可达到属/菌群水平的准确鉴定;基质辅助激光解析电离飞行质谱(MALDI-TOF MS)以及16S rRNA序列分析技术可达到菌群的准确鉴定;看家基因如 recA或hisA等的序列分析,基本可达到菌种水平的鉴定,必要时,可补充多位点序列分型(MLST)进行确认。MLST、核糖体分型(Ribotyping)或全基因组测序(WGS)技术则适用于菌株水平的分型和溯源。结论:明确不同的鉴定技术对于Bcc的鉴定能力和应用特点,针对不同的鉴定需求给出相应鉴定方法的建议,为在实际应用中涉及Bcc检验、鉴定和溯源分析的生产企业、检验人员提供参考和借鉴。
英文摘要:
      Objective: To explore the identifi cation strategy of suitability for Burkholderia cepacia Complex (Bcc) in the control of pharmaceutical microorganisms. Methods: Considering the requirements of Bcc identifi cation and typing in pharmaceutical microbial control, the characteristics and capabilities of identification or typing of microbial identification techniques widely used at present were described and discussed, and identification strategies to meet the requirements of diff erent identifi cation levels were provided. Results: For Bcc, diff erent kinds of identifi cation methods are able to achieve diff erent identifi cation levels. Manual/Automated biochemical identifi cation systems are able to achieve accurate identifi cation at the genus/complex level; matrix-assisted laser desorption ionization fl ight mass spectrometry (MALDI-TOF MS) and 16S rRNA sequence analysis technology are able to achieve accurate identification of "Complex" level; housekeeping genes sequence analysis such as recA or hisA, etc., are able to basically reach the species level. If necessary, multilocus sequence typing (MLST) should be supplemented for confi rmation. MLST, Ribotyping and Whole Genome Sequencing (WGS) technology are suitable for strain-level typing and traceability. Conclusion: The identification ability and application characteristics of different identification technologies for Bcc are clarified, and corresponding identification methods are recommendated for diff erent identifi cation requirements, so as to provide references for manufacturers and inspectors involved in Bcc inspection, identification and traceability analysis in practical application.
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