CLSI C29-A2-2000

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October 2000

C29-A2

Standardization of Sodium and Potassium

Ion-Selective Electrode Systems to the Flame

Photometric Reference Method; Approved

Standard—Second Edition

This document contains recommendations on the expression

of the results of ion-selective electrode measurement of

sodium and potassium ion activities in undiluted serum,

plasma, or whole blood in clinical practice.

A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process.

Clinical and Laboratory Standards Institute

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

The Clinical and Laboratory Standards Institute (CLSI) is a not-for-proﬁt 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 clinical laboratory

standards and guidelines that help laboratories fulﬁll 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 modiﬁcation to keep pace with advancements 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 addressed according to the consensus process by a committee of experts.

Appeals Process

If it is believed that an objection has not been adequately addressed, the process for appeals is documented in

the CLSI Administrative Procedures.

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available upon request.

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

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

Clinical and Laboratory Standards Institute

950 West Valley Road, Suite 2500

Wayne, PA 19087 USA

P: 610.688.0100

F: 610.688.0700

www.clsi.org

standard@clsi.org

C29-A2

Vol. 20 No. 17

ISBN 1-56238-410-4 Replaces C29-A

ISSN 0273-3099 Vol. 15 No. 1

Standardization of Sodium and Potassium Ion-Selective Electrode

Systems to the Flame Photometric Reference Method; Approved

Standard—Second Edition

Volume 20 Number 17

Paul D’Orazio, Ph.D

W. Gregory Miller, Ph.D., Chairholder

Gary L. Myers, Ph.D., Vice-Chairholder

Basil T. Doumas, Ph.D.

John H. Eckfeldt, M.D., Ph.D.

Susan A. Evans, Ph.D.

Gary A. Graham, Ph.D., DABCC

Patrick J. Parsons, Ph.D.

Noel V. Stanton, M.S.

Abstract

Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the Flame Photometric Reference Method;

Approved Standard—Second Edition (CLSI document C29-A2) offers a protocol for standardizing instruments that contain direct

ion-selective electrodes to give results in concentration terms that are verifiable to the reference method (flame photometry) for

specimens with normal plasma water (i.e., lipids and proteins). The document describes the preparation of serum pools to carry

out the procedure. Laboratories without the resources, equipment, or personnel to prepare the pools can purchase them from the

National Institute of Standards and Technology (Gaithersburg, MD). It is recommended in C29-A2 that the accuracy of each new

direct potentiometric instrument be verified with these standard pools, together with the flame photometer, if it is also used to

report patient results.

Clinical and Laboratory Standards Institute (CLSI). Standardization of Sodium and Potassium Ion-Selective Electrode Systems to

the Flame Photometric Reference Method; Approved Standard—Second Edition. CLSI document C29-A2 (ISBN 1-56238-410-

4). Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 2000.

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 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.

NOTE: This document is no longer being reviewed as part of the CLSI

consensus process. However, because of its usefulness to segments of the

health care community, it is available for its informational content.

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摘要：

CLSI C29-A2-2000 是美国临床实验室标准化协会（CLSI）发布的一项权威标准规范文档，专门针对临床实验室中特定检测项目或操作流程提供统一的技术指南与质量控制要求。该标准旨在通过规范化的方法减少实验误差、提升结果可重复性，并确保不同实验室间数据的一致性与可比性。C29-A2-2000 版本在前期基础上进行了修订与优化，适用于医学检验、病理诊断及相关研究领域，是实验室质量管理体系建设和认证审核的重要参考依据。遵循此标准有助于实验室提高检测准确性，降低合规风险，促进临床诊疗决策的科学性与

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