CLSI M100-2025 35th 第35版英文版抗微生物药物敏感性试验执行标准 Performance Standards for Antimicrobial Susceptibility Testing

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CLSI M100™

Performance Standards for Antimicrobial

Susceptibility Testing

CLSI M100 includes updated tables for the Clinical and Laboratory Standards Institute

antimicrobial susceptibility testing standards CLSI M02, M07, and M11.

A CLSI supplement for global application.

35th Edition

Clinical and Laboratory Standards Institute

Setting the standard for quality in medical laboratory testing around the world.

The Clinical and Laboratory Standards Institute (CLSI) is a not-for-prot membership organization that brings

together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a

common cause: to foster excellence in laboratory medicine by developing and implementing medical laboratory

standards and guidelines that help laboratories fulll their responsibilities with eﬃciency, eﬀectiveness, and global

applicability.

Consensus Process

Consensus—the substantial agreement by materially aﬀected, competent, and interested parties—is core to the

development of all CLSI documents. It does not always connote unanimous agreement but does mean that the

participants in the development of a consensus document have considered and resolved all relevant objections

and accept the resulting agreement.

Commenting on Documents

CLSI documents undergo periodic evaluation and modication to keep pace with advances in technologies,

procedures, methods, and protocols aﬀecting the laboratory or health care.

CLSI’s consensus process depends on experts who volunteer to serve as contributing authors and/or as participants

in the reviewing and commenting process. At the end of each comment period, the committee that developed

the document is obligated to review all comments, respond in writing to all substantive comments, and revise the

draft document as appropriate.

Comments on published CLSI documents are equally essential and may be submitted by anyone, at any time, on

any document. All comments are managed according to the consensus process by a committee of experts.

Appeal Process

When it is believed that an objection has not been adequately considered and responded to, the process for

appeal, documented in the CLSI Standards Development Policies and Processes, is followed.

All comments and responses submitted on draft and published documents are retained on le at CLSI and are

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Do you use CLSI documents in your workplace? Do you see room for improvement? Would you like to get

involved in the revision process? Or maybe you see a need to develop a new document for an emerging

technology? CLSI wants to hear from you. We are always looking for volunteers. By donating your time and talents

to improve the standards that aﬀect your own work, you will play an active role in improving public health across

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For additional information on committee participation or to submit comments, contact CLSI.

Clinical and Laboratory Standards Institute

P: +1.610.688.0100

F: +1.610.688.0700

www.clsi.org

standard@clsi.org

CLSI M100-Ed35

January 2025

Replaces CLSI M100-Ed34

Performance Standards for Antimicrobial Susceptibility Testing

James S. Lewis II, PharmD, FIDSA

Amy J. Mathers, MD, D(ABMM)

April M. Bobenchik, PhD, D(ABMM)

Alexandra Lynn Bryson, PhD, D(ABMM)

Shelley Campeau, PhD, D(ABMM)

Sharon K. Cullen, BS, RAC

Tanis Dingle, PhD, D(ABMM), FCCM

German Esparza, MSc

Romney M. Humphries, PhD, D(ABMM), FIDSA

Thomas J. Kirn, Jr., MD, PhD

Joseph Lutgring, MD

Navaneeth Narayanan, PharmD, MPH

Elizabeth Palavecino, MD

Virginia M. Pierce, MD, FIDSA

Audrey N. Schuetz, MD, MPH, D(ABMM)

Susan Sharp, PhD, D(ABMM), F(AAM)

Patricia J. Simner, PhD, D(ABMM)

Pranita D. Tamma, MD, MHS

Melvin P. Weinstein, MD

Abstract

The data in the tables are valid only if the methodologies in CLSI M02,1 M07,2 and M113 are followed. These standards

contain information about disk diﬀusion (CLSI M021) and dilution (CLSI M072 and CLSI M113) test procedures for

aerobic and anaerobic bacteria. Clinicians depend heavily on information from the microbiology laboratory for

treating their seriously ill patients. The clinical importance of antimicrobial susceptibility test results demands that

these tests be performed under optimal conditions and that laboratories have the capability to provide results for

the newest antimicrobial agents. The tables presented in CLSI M100 represent the most current information for drug

selection, interpretation, and quality control using the procedures standardized in CLSI M02,1 M07,2 and M11.3 Users

should replace previously published tables with these new tables. Changes in the tables since the previous edition

appear in boldface type.

Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing.

35th ed. CLSI supplement M100 (ISBN 978-1-68440-262-5 [Print]; ISBN 978-1-68440-263-2 [Electronic]). Clinical and

Laboratory Standards Institute, USA, 2025.

The Clinical and Laboratory Standards Institute consensus process, which is the mechanism for moving a document through

two or more levels of review by the health care community, is an ongoing process. Users should expect revised editions of any

given document. Because rapid changes in technology may aﬀect the procedures, methods, and protocols in a standard or

guideline, users should replace outdated editions with the current editions of CLSI documents. Current editions are listed in

the CLSI catalog and posted on our website at www.clsi.org.

If you or your organization is not a member and would like to become one, or to request a copy of the catalog, contact us at:

P: +1.610.688.0100 F: +1.610.688.0700 E: customerservice@clsi.org W: www.clsi.org

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标签： #抗微生物药物敏感性试验 #临床微生物学 #药敏试验指南

摘要：

《CLSI M100（2025第35版英文版）抗微生物药物敏感性试验执行标准》由临床和实验室标准协会（CLSI）发布，为抗菌药物敏感性试验提供了全面且详细的标准，旨在确保微生物实验室检测结果的准确性与可靠性，进而辅助临床医生做出合理的抗菌药物治疗决策。表2B-3和附件F：删除了不再认为对洋葱伯克霍尔德菌复合群可靠的MIC折点。如果需要AST，添加了处理该复合群的说明。为该复合群设计了ECV，并将其添加到附件F中。对四环素敏感的分离株，可以认为对多西环素和米诺环素敏感。如果治疗需要多西环素或米诺环素的结果，则应对四环素中介或耐药的分离株进行检测。表2A-1、表3B和表3C：加强碳青霉烯酶检测性能的建议，包括碳青霉烯酶类型的鉴定，以支持碳青霉烯类耐药肠杆菌目细菌的治疗决策和感染控制实践。附件I：增加了新的附件，其中包含制定质量控制计划的建议，包括选择质量控制菌株和质量控制检测频率。

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CLSI M100-2025 35th 第35版英文版抗微生物药物敏感性试验执行标准 Performance Standards for Antimicrobial Susceptibility Testing

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