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Full Description

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.

Document History

  1. CLSI EP21


    Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures, 2nd Edition, EP21Ed2E

    • Most Recent
  2. CLSI EP21-A

    Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline, EP21AE

    • Historical Version