CLSI EP21
Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures, 2nd Edition, EP21Ed2E
standard by Clinical and Laboratory Standards Institute, 07/01/2016
J. Rex Astles, Ph.D., FACB, DABCC, et al.
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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.
