Analytical performance specifications in the clinical laboratory: Historical evolution, conceptual foundations and a practical decision framework.

Abstract

Analytical performance specifications (APS) represent a crucial part of analytical quality. Laboratories use APS in the forms of total error (TE), imprecision, bias and measurement uncertainty (MU) to accurately assess the quality of the analytical phase. This narrative review summarizes the history and evolution of APS. It also reviews the current consensus on APS models as represented by the 2014 Milan models. Moreover, it illustrates the similarities and differences of TE and MU approaches and their use in the clinical laboratories. Finally, it provides a decision and practical framework for laboratories to choose APS in real practice and points to the future hot topics related to APS.