Analytical Issues for Clinical Use of Cardiac Troponin

Abstract

Guidelines jointly developed by the European Society of Cardiology and the American College of Cardiology have established cardiac troponin (T or I) as the biomarker of choice for the diagnosis of acute coronary syndromes (ACSs) and risk stratification of patients who present with ischemic symptoms suggestive of ACS. Despite these international guidelines, a number of analytic issues have slowed the acceptance and implementation of this test worldwide. Regarding precision, analytic sensitivity, and specificity, the performance of commercial assays is variable. Moreover, there is a lack of assay standardization for troponin I results among commercial assays. The release of a standard reference material should initiate the process of assay harmonization. It is important that clinicians be familiar with the analytic performance (i.e., level of 10% coefficient of variation) and appropriate cut points (99th percentile and/or evidence-based decision limits) for all troponin assays used (both laboratory-based and point of care) at their institution. In time, it is hoped that all troponin assays will be standardized and exhibit similar performance to each other, as is the case for the majority of other clinical laboratory analytes today.