Historical
CLSI EP21-A
Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline
This document provides manufacturers and end users with a means to estimate total analytical error for an assay. A data collection protocol and an analysis method which can be used to judge the clinical acceptability of new methods using patient specimens are included. These tools can also monitor an assayÆs total analytical error by using quality control samples. The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus guideline for use in satisfying a regulatory requirement
Content Provider
Clinical And Laboratory Standards Institute [clsi]
