CLSI EP21

Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures, 2nd Edition

This guideline provides manufacturers and end users with an understanding of concepts related to total analytical error (TAE) for quantitative measurement procedures. An experimental protocol and data analysis method are provided to estimate TAE based upon a comparison of methods experiment with patient specimens, and to assess it relative to a pre-established goal for clinical acceptability.

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Chairholder: J. Rex Astles, PhD, FACB, DABCC

Date of Publication: July 1, 2016

Order Code PDF: CLSI EP21Ed2E
ISBN Number: 1-56238-941-6

Order Code Print: CLSI EP21Ed2
ISBN Number: 1-56238-940-8

Edition: Second

Pages: 68

CLSI EP21 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.

CLSI EP21 Abstract

Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures, 2nd Edition This guideline provides manufacturers and end users with an understanding of concepts related to total analytical error (TAE) for quantitative measurement procedures. An experimental protocol and data analysis method are provided to estimate TAE based upon a comparison of methods experiment with patient specimens, and to assess it relative to a pre-established goal for clinical acceptability. Chairholder: J. Rex Astles, PhD, FACB, DABCC Organization: Centers for Disease Control and Prevention Date of Publication: July 2016 ISBN Number: 1-56238-940-8 Edition: Second Edition Pages: 68 Nonmember Price: $180.00 Membership discount will be applied at checkout. This document is available for preorder