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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Publication Details

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

Date of Publication: July 1, 2016

ISBN Number: 1-56238-940-8

Order Code PDF: EP21Ed2E

Order Code Print: EP21Ed2

Edition: Second

Pages: 68

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.