Analysis reveals how different methods for estimating total allowable error affect six sigma metrics, implying varying analytical performance across serology tests.
Key Points
TEa significantly impacts the Six Sigma values, affecting quality control monitoring in serology tests.
Sigma values varied widely based on the method of estimating TEa, with some methods yielding results below 3 Sigma.
Proficiency-based TEa showed greater variability in Sigma results compared to IQC-based estimation.
Cut-off-based TEa produced the highest proportion of Sigma values above 6 Sigma, though it complicated QC monitoring.