Historical
EP21-A
Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline
NCCLS document EP21-A-Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline provides manufacturers and end users with a means to estimate total analytical error for an assay. The procedure includes a data collection protocol and analysis method, which is largely graphical. The result is compared to a total analytical error goal. The procedure described herein relies on a method comparison data collection procedure such as that described in NCCLS document EP9-Method Comparison and Bias Estimation Using Patient Samples. Two calculation methods are used: parametric and nonparametric. NCCLS document EP21 can be used to judge the clinical laboratory acceptability of new methods by using patient specimens, or to monitor an assay's total analytical error by using quality control samples.
Clinical And Laboratory Standards Institute [clsi]