CLSI H02-A5-2011

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May 2011

H02-A5

Procedures for the Erythrocyte Sedimentation

Rate Test; Approved Standard—Fifth Edition

This document provides a description of the principle, materials,

and procedure for a standardized erythrocyte sedimentation rate

(ESR) method; a selected routine method, as well as a procedure

to evaluate routine methods; and an outline of quality control

programs for the ESR test.

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 Standards Development Policies and Process document.

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

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

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 the globe.

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

H02-A5

ISBN 1-56238-753-7 (Print) Vol. 31 No. 11

ISBN 1-56238-754-5 (Electronic) Replaces H02-A4

ISSN 0273-3099 Vol. 20 No. 27

Procedures for the Erythrocyte Sedimentation Rate Test; Approved

Standard—Fifth Edition

Volume 31 Number 11

Josep M. Jou, MD, PhD

Francesco Cocola

Bruce H. Davis, MD

Chiara Derioni

John Dorman, MT(ASCP)

John A. Koepke, MD

S. Mitchell Lewis

Renzo Montanari

Monisha Parikh

Mario Plebani, MD

Susan S. Smith

Abstract

Clinical and Laboratory Standards Institute document H02-A5—Procedures for the Erythrocyte Sedimentation Rate Test;

Approved Standard—Fifth Edition is a revision of the fourth edition approved standard (H02-A4) published in December 2000.

The document outlines the necessary details for the performance of a standardized (Westergren) method on diluted (1:4) blood

specimens for the determination of the erythrocyte sedimentation rate (ESR). Quality assurance and evaluation of other methods

to measure the ESR are also described, including procedures for the preparation of a fresh blood reference material for use in the

laboratory or manufacturing of ESR devices. This standard provides guidance for the validation, verification, quality assurance,

and quality control of ESR measurement devices or related controls. The intended audience includes manufacturers of such

devices, end-user clinical laboratories, accrediting organizations, and regulatory bodies.

Clinical and Laboratory Standards Institute (CLSI). Procedures for the Erythrocyte Sedimentation Rate Test; Approved

Standard—Fifth Edition. CLSI document H02-A5 (ISBN 1-56238-753-7 [Print]; ISBN 1-56238-754-5 [Electronic]). Clinical and

Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 2011.

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.

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摘要：

CLSI H02-A5-2011 是临床实验室标准化协会（CLSI）发布的关于血液标本采集与处理的标准规范，该标准全称为“Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard—Fifth Edition”。作为行业广泛认可的权威指南，H02-A5-2011 详细规定了静脉采血的操作流程、患者与标本识别要求、采血设备的选择与使用、标本处理与运输规范，以及相关质量控

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