Quality requirements for troponin assays – An overview

Clinical decisions rhat rely heavily upon cardiac troponin (cTn) measurement are substantially impacted by the quality of assays in the marlcetplace. Therefore, a clear definition of quality requirements for cTn measurement is pivotal to permit in vitro diagnostics (IVD) manufacturers to market assays that are reliable for clinical use. Analytical aspects such as calibrator characterisation, antibody specificity, assay sensitivity and imprecision, and interferents, as well as preanalytical aspects such as sample type, and stability and storage of specimens must be documented by using well defined protocols. This overview updates these aspects that, if correctly applied, can contribute to alleviate inconsistencies and confusion that still exist for cTn assays.