Judging the clinical suitability of analytical performance of cardiac troponin assays.

Abstract

New millennium diagnostic criteria for acute myocardial infarction precipitated a revolutionary shift from an approach based primarily on electrocardiography and clinical symptoms to a strategy based on biomarkers, and preferably cardiac troponins (cTn) I and T.In the last 20 years, clinical recommendations have strengthened the role of cTn and led to the development ofhighly sensitive (hs-cTn) assays, which are now leadingplayers in all current clinical practice guidelines. To optimize the clinical use of these hs-cTn assays, focus on their analytical aspects has become increasingly important, emphasizing the need for the establishment of suitable analytical performance by the definition andimplementation of appropriate specifications. An accurate estimate of measurement uncertainty, together with the acquisition of the highest analytical quality whenverylow concentrations of hs-cTn are measured, are essential requirements and should represent a practical laboratory standard in assuring optimal clinical use.Additional goals for further improving the quality of laboratory information should be the establishment of robust data concerning biological variation of cTn and theresolution of practical challenges opposed to the harmonization of cTn I results obtained by differing commercial measuring systems.