Uncertainty calculation for calibrators and controls of laboratory diagnostic assays.

The uncertainty of the results from calibrators and controls is an important component of the overall uncertainty of the results of medical samples. The purpose of this note is to review procedures of standardization and to describe the respective calculation of the uncertainty components for calibrators and controls of commercial routine diagnostic assays. The authors hope that the laying out of the procedures for uncertainty calculation of routine calibrators and controls contributes (i) to the transparency on how this component of uncertainty is derived and (ii) to a better understanding and use of the uncertainty concept in the routine laboratory.