Analytical performance of cardiac troponin assays - Current status and future needs

Abstract

Concurrent with the introduction of cardiac troponin measurements into the diagnostic definition of myocardial infarction (MI), clinicians and laboratory professionals signaled a clear clinical need for improved analytical quality. This was an important precipitant for developing high-sensitivity cardiac troponin (hs-cTn) assays, currently used in rapid algorithms guiding investigations of patients presenting to the emergency department with possible MI. The hs-cTn assays were also important for the detection and monitoring of low-grade chronic myocardial injury, a condition that has been linked to increased long-term risk of cardiovascular morbidity and mortality. This review summarizes the general recommendations for defining analytical performance specifications while providing relevant clinical situations related to analytical performance. Importantly, outcome studies suggest analytical quality performance for hs-cTn is sufficient for early discharge of patients investigated for possible MI. However, bias due to change in calibrators or reagents may significantly affect the percentage of patients discharged. Biological variation data is suitable for defining performance specifications when hs-cTn measurements are used for diagnosing and monitoring chronic myocardial injury. Further improvement in analytical performance for hs-cTn testing may result in even faster decision making in the emergency setting; while also identifying those with chronic injury at risk for an adverse cardiac event.

Keywords: Acute coronary syndrome; Analytical quality; Analytical variation; Biological variation; Clinical outcome; Myocardial infarction; Myocardial injury; Troponin.