Total Analytical Error and Measurement Uncertainty for Analytical Performance Evaluation and Determination of Gray Zones of Glucose Critical Value Limits.

Abstract

Total analytical error (TAE) and measurement uncertainty (MU) are important approaches to evaluating and improving the quality of measurement procedures. This study evaluates glucose analytical performance (AP) according to TAE and MU and calculates gray zones of glucose critical value limits. Using TAE and MU values, AP was evaluated according to 5 different analytical performance specifications (APS) and the gray zones of critical value limits were calculated. The number of patients in these zones was compared. TAE was higher than MU at all 3 levels. The AP for the low glucose level was poor. The number of patients in the gray zones was statistically higher in the TAE groups than in the MU groups (P < .05). TAE and MU values can be used to evaluate the AP of glucose measurement as well as to evaluate the compliance of patient results with decision limits by creating gray zones.