Standard Document
Second Edition
Method Evaluation

CLSI EP17

Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures

This document guides you through the evaluation and documentation of the detection capability of clinical laboratory measurement procedures, including limits of blank, detection, and quantitation. It also helps you verify manufacturers’ detection capability claims and properly use and interpret different detection capability estimates.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of June 2017. 

 

June 18, 2012
James F. Pierson-Perry

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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.

Scope

This document provides guidelines for the evaluation and verification of detection capability claims of clinical laboratory measurement procedures (ie, limit of blank [LoB], limit of detection [LoD], and limit of quantitation [LoQ]), as well as for their proper use, documentation, and interpretation. This guidance is suitable both for commercial products as well as laboratory-developed tests. It is particularly important for measurement procedures for which the associated measurand’s medical decision level is low (ie, approaching zero). 

The intended users of this guideline are manufacturers of in vitro diagnostic (IVD) reagents, regulatory bodies, and clinical laboratory personnel.

Product Details
EP17A2E
1-56238-796-0
80
Additional Details

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

A CLSI-IFCC joint project.

This document is available in electronic format only.

Authors
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
Supporting Resources
CLSI EP17IG
Evaluation of Detection Capability Implementation Guide
Companion
Method Evaluation
Free
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.

Scope

This document provides guidelines for the evaluation and verification of detection capability claims of clinical laboratory measurement procedures (ie, limit of blank [LoB], limit of detection [LoD], and limit of quantitation [LoQ]), as well as for their proper use, documentation, and interpretation. This guidance is suitable both for commercial products as well as laboratory-developed tests. It is particularly important for measurement procedures for which the associated measurand’s medical decision level is low (ie, approaching zero). 

The intended users of this guideline are manufacturers of in vitro diagnostic (IVD) reagents, regulatory bodies, and clinical laboratory personnel.

Additional Details

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

A CLSI-IFCC joint project.

This document is available in electronic format only.

Authors
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
Supporting Resources
CLSI EP17IG
Evaluation of Detection Capability Implementation Guide
Companion
Method Evaluation
Free