Decision and detection limits for linear homoscedastic assays.

This paper focuses on the effect of estimating the calibration parameters on the decision and detection limits for linear homoscedastic assays. Assay decision and detection limits are defined. For linear homoscedastic assays expressions for these limits are derived when the calibration parameters are known and unknown. These expressions, together with others previously reported in the literature, are used to calculate limits for a particular example of a cyclic AMP assay. The various methods of computing decision and detection limits are compared in a simulation study. The results demonstrate the importance of taking into consideration the variation in the estimators of the calibration parameters.