CLSI M06-A2-2006

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(Formerly NCCLS)

Providing NCCLS standards and guidelines,

ISO/TC 212 standards, and ISO/TC 76 standards

Clinical and Laboratory Standards Institute

Providing CLSI/NCCLS standards and guidelines, ISO/TC 212 standards, and ISO/TC 76 standards

Clinical and Laboratory Standards Institute (CLSI,

formerly NCCLS) is an international, interdisciplinary,

nonprofit, standards-developing, and educational

organization that promotes the development and use of

voluntary consensus standards and guidelines within the

healthcare community. It is recognized worldwide for the

application of its unique consensus process in the

development of standards and guidelines for patient

testing and related healthcare issues. Our process is

based on the principle that consensus is an effective and

cost-effective way to improve patient testing and

healthcare services.

In addition to developing and promoting the use of

voluntary consensus standards and guidelines, we

provide an open and unbiased forum to address critical

issues affecting the quality of patient testing and health

care.

PUBLICATIONS

A document is published as a standard, guideline, or

committee report.

Standard A document developed through the consensus

process that clearly identifies specific, essential

requirements for materials, methods, or practices for use

in an unmodified form. A standard may, in addition,

contain discretionary elements, which are clearly

identified.

Guideline A document developed through the

consensus process describing criteria for a general

operating practice, procedure, or material for voluntary

use. A guideline may be used as written or modified by

the user to fit specific needs.

Report A document that has not been subjected to

consensus review and is released by the Board of

Directors.

CONSENSUS PROCESS

The CLSI voluntary consensus process is a protocol

establishing formal criteria for:

• the authorization of a project

• the development and open review of documents

• the revision of documents in response to comments

by users

• the acceptance of a document as a consensus

standard or guideline.

Most documents are subject to two levels of consensus—

“proposed” and “approved.” Depending on the need for

field evaluation or data collection, documents may also be

made available for review at an intermediate consensus

level.

Proposed A consensus document undergoes the first stage

of review by the healthcare community as a proposed

standard or guideline. The document should receive a wide

and thorough technical review, including an overall review

of its scope, approach, and utility, and a line-by-line review

of its technical and editorial content.

Approved An approved standard or guideline has achieved

consensus within the healthcare community. It should be

reviewed to assess the utility of the final document, to

ensure attainment of consensus (i.e., that comments on

earlier versions have been satisfactorily addressed), and to

identify the need for additional consensus documents.

Our standards and guidelines represent a consensus opinion

on good practices and reflect the substantial agreement by

materially affected, competent, and interested parties

obtained by following CLSI’s established consensus

procedures. Provisions in CLSI standards and guidelines

may be more or less stringent than applicable regulations.

Consequently, conformance to this voluntary consensus

document does not relieve the user of responsibility for

compliance with applicable regulations.

COMMENTS

The comments of users are essential to the consensus

process. Anyone may submit a comment, and all comments

are addressed, according to the consensus process, by the

committee that wrote the document. All comments,

including those that result in a change to the document when

published at the next consensus level and those that do not

result in a change, are responded to by the committee in an

appendix to the document. Readers are strongly encouraged

to comment in any form and at any time on any document.

Address comments to Clinical and Laboratory Standards

Institute, 940 West Valley Road, Suite 1400, Wayne, PA

19087, USA.

VOLUNTEER PARTICIPATION

Healthcare professionals in all specialties are urged to

volunteer for participation in CLSI projects. Please contact

us at customerservice@clsi.org or +610.688.0100 for

additional information on committee participation.

M6-A2

ISBN 1-56238-594-1

Volume 26 Number 6 ISSN 0273-3099

Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved

Standard—Second Edition

Robert P. Rennie, PhD

Donald R. Callihan, PhD

Arthur L. Barry, PhD

Karen Krisher, PhD, D(ABMM)

Susan D. Munro, MT(ASCP)

Katherine Sei

Roxanne G. Shively, MS

Jana M. Swenson, MMSc

Abstract

Clinical and Laboratory Standards Institute document M6-A2—Protocols for Evaluating Dehydrated Mueller-Hinton Agar;

Approved Standard—Second Edition describes three protocols for the evaluation of dehydrated Mueller-Hinton agar in the disk

diffusion procedure for antimicrobial susceptibility testing. The first protocol is for use by manufacturers to evaluate production

lots of Mueller-Hinton agar. The second and third are for selection and stability testing of primary and secondary reference lots of

Mueller-Hinton agar.

Performance of production lots is determined by comparison with the primary standard lot, which is provided to manufacturers

upon request. The secondary standard lot may be used when the supply of the primary standard is threatened or its performance

becomes unsatisfactory. Acceptable lots may be labeled with a statement indicating that the lot was tested according to the

protocol found in this document and meets the acceptance limits of that protocol. These acceptance criteria apply only to disk

diffusion procedures. They do not qualify Mueller-Hinton agar for other methods, such as agar dilution or antibiotic gradient.

Performance of new reference lots is determined by comparison with the current primary standard lot. The original primary

reference standard lot was selected in 1983 and the secondary standard lot in 1984. Replacement reference standards were

selected in 1992, 1996, and again in 2002.

Clinical and Laboratory Standards Institute (CLSI). Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved

Standard—Second Edition. CLSI document M6-A2 (ISBN 1-56238-594-1). Clinical and Laboratory Standards Institute, 940

West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2006.

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 healthcare 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/NCCLS documents. Current editions are

listed in the CLSI catalog, which is distributed to member organizations, and to nonmembers on request. If your organization is

not a member and would like to become one, and to request a copy of the catalog, contact us at: Telephone: 610.688.0100; Fax:

610.688.0700; E-Mail: customerservice@clsi.org; Website: www.clsi.org

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摘要：

CLSI M06-A2-2006 是美国临床和实验室标准协会（CLSI）发布的一项重要标准，标题为《厌氧菌的抗菌药物敏感性试验方法——第二版》。该标准提供了针对厌氧菌进行抗菌药物敏感性测试的统一操作规范，包括培养基选择、接种物制备、孵育条件、质量控制及结果判读等关键步骤，适用于临床微生物实验室对厌氧菌引起的感染（如腹腔感染、牙源性感染、盆腔感染等）进行准确的药物敏感性评估。遵循此标准有助于提高检测结果的可重复性和临床相关性，指导合理使用抗生素，延缓耐药性发展。该文件适用于实验室技术人员、微生物学

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CLSI M06-A2-2006

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