Analytical performance specifications for changes in assay bias (bias) for data with logarithmic distributions as assessed by effects on reference change values

摘要

Background The distributions of within-subject biological variation are usually described as coefficients of variation, as are analytical performance specifications for bias, imprecision and other characteristics. Estimation of specifications required for reference change values is traditionally done using relationship between the batch-related changes during routine performance, described as bias, and the coefficients of variation for analytical imprecision (CVA): the original theory is based on standard deviations or coefficients of variation calculated as if distributions were Gaussian.