CLSI EP17-A2-2012

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June 2012

EP17-A2

Evaluation of Detection Capability for Clinical

Laboratory Measurement Procedures;

Approved Guideline—Second Edition

This document provides guidance for evaluation and documentation of

the detection capability of clinical laboratory measurement procedures

(ie, limits of blank, detection, and quantitation), for veriﬁcation of

manufacturers’ detection capability claims, and for the proper use and

interpretation of different detection capability estimates.

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

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 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 managed according to the consensus process by a committee of experts.

Appeals Process

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

appeals, 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

available upon request.

Get Involved—Volunteer!

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 additional 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: +1.610.688.0100

F: +1.610.688.0700

www.clsi.org

standard@clsi.org

ISBN 1-56238-795-2 (Print) EP17-A2

ISBN 1-56238-796-0 (Electronic) Vol. 32 No. 8

ISSN 1558-6502 (Print) Replaces EP17-A

ISSN 2162-2914 (Electronic) Vol. 24 No. 34

Evaluation of Detection Capability for Clinical Laboratory Measurement

Procedures; Approved Guideline—Second Edition

Volume 32 Number 8

James F. Pierson-Perry

Jeffrey E. Vaks, PhD

A. Paul Durham, MA

Christian Fischer, MD

Cornelius Gutenbrunner, PhD

David Hillyard, MD

Marina V. Kondratovich, PhD

Paula Ladwig

Robert A. Middleberg, PhD, DABFT, DABCC

Abstract

Clinical and Laboratory Standards Institute document EP17-A2—Evaluation of Detection Capability for Clinical Laboratory

Measurement Procedures; Approved Guideline—Second Edition provides guidance for evaluating the detection capability of

clinical laboratory measurement procedures (ie, limits of blank, detection, and quantitation), for verification of manufacturers’

detection capability claims, and for the proper use and interpretation of different detection capability estimates. EP17 is intended

for use by manufacturers of in vitro diagnostic tests, regulatory bodies, and clinical laboratories.

Clinical and Laboratory Standards Institute (CLSI). Evaluation of Detection Capability for Clinical Laboratory Measurement

Procedures; Approved Guideline—Second Edition. CLSI document EP17-A2 (ISBN 1-56238-795-2 [Print]; ISBN 1-56238-796-

0 [Electronic]). Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087

USA, 2012.

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 EP17-A2-2012 是临床与实验室标准协会（CLSI）发布的关于检测能力评估的权威指南，正式名称为《定量测量程序的检测能力评估：空白限、检出限与定量限的确定》（第二版）。该标准详细规定了实验室在开发或验证定量检测方法时，如何科学地确定空白限（LoB）、检出限（LoD）和定量限（LoQ），以确保低浓度样本的检测结果具有足够的可靠性与准确性。EP17-A2替代了第一版EP17-A，在统计方法、样本处理和数据解释方面进行了重要更新，适用于临床化学、免疫学、分子诊断等多个医学检验领域。遵

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