| 摘要: |
| ［摘要］ 《抗微生物药物敏感性试验执行标准》（M100，第35版）于2025年1月27日发布，其在方法学地位的变更、折点调整和室内质量控制等方面都有重要的更新。在概念及方法学地位变更方面，第35版M100文件将凝固酶阴性葡萄球菌和凝固酶阳性葡萄球菌（除外金黄色葡萄球菌复合群）的所有葡萄球菌菌种定义为除金黄色葡萄球菌外的其他葡萄球菌(SOSA)，强调SOSA的核心目的主要在于精准诊疗、耐药性管理等方面。明确将纸片扩散法定为标准方法。折点标准的修改主要涉及不动杆菌属和洋葱伯克霍尔德菌复合群等。在质量控制方面，引入个性化质控计划（IQCP）原则。上述更新对临床微生物学的精准化发展有重要意义。 |
| 关键词: 抗微生物药物敏感性试验 纸片扩散法 葡萄球菌 产碳青霉烯酶肠杆菌目 鲍曼不动杆菌 洋葱伯克霍尔德菌 指南解读 |
| DOI：10.3969/j.issn.1674-3806.2025.07.02 |
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| 基金项目: |
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| Interpretation of the main updates to CLSI Document M100(the 35th Edition) in 2025 |
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ZHANG Lijun1, LI Xiang2, ZHANG Qiuying3, ZHU Congzhi4, NING Yongzhong2
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1.Department of Laboratory Medicine, the Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China; 2.Department of Laboratory Medicine, Chuiyangliu Hospital Affiliated to Tsinghua University, Beijing 100022, China; 3.Department of Laboratory Medicine, Suizhou Hospital Affiliated to Hubei University of Medicine(Suizhou Central Hospital), Suizhou 441300, China; 4.Department of Laboratory Medicine, Dalian Economic and Technological Development Area Hospital, Dalian 116600, China
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| Abstract: |
| ［Abstract］ Performance Standards for Antimicrobial Susceptibility Testing(M100, the 35th Edition) was released on January 27, 2025, with important updates in terms of methodological status changes, breakpoint adjustments and internal quality control. Regarding the conceptual and methodological changes, the document M100(the 35th Edition) defines all the Staphylococcus species of coagulase-negative and coagulase-positive staphylococci(excluding Staphylococcus aureus complex) as staphylococci other than Staphylococcus aureus(SOSA). This definition emphasizes SOSA, whose core purpose is to facilitate precise diagnosis and treatment, antimicrobial resistance management and other aspects. The document M100(the 35th Edition) explicitly defines the disk diffusion method as a standard method. The modification of the breakpoint criteria mainly involves Acinetobacter species and Burkholderia cepacia complex. For the quality control, the principle of Individualized Quality Control Plan(IQCP) is introduced. The above-mentioned updates are of great significance for the development of precision in clinical microbiology. |
| Key words: Antimicrobial susceptibility testing Disk diffusion method Staphylococcus Carbapenemase-producing Enterobacterales Acinetobacter baumannii Burkholderia cepacia Guideline interpretation |
