Analytical and Clinical Characterization of a Novel High-Sensitivity Cardiac Troponin Assay in a United States Population.

CONCLUSION: Analytical and clinical performance of the ACCESS hsTnI assay meets the definition of a hs cTn method. The ACCESS hsTnI assay has good precision over a wide range, no significant interferences, and sensitivity >90% and NPV≥99%. Performance is appropriate for aiding in AMI diagnosis. BACKGROUND: Approximately 7 million people in the United States present to emergency departments (ED) each year with signs and symptoms suggestive of the acute coronary syndromes (ACS), a continuum of cardiac ischemia that spans from stable angina to acute myocardial infarction (AMI). Of these, about 20% of patients (1.3 million) are eventually diagnosed with unstable angina or acute myocardial infarction [1]. Rapid and accurate identification of AMI patients is important for preventing mortality and avoiding unnecessary procedures, lengthy waiting time in EDs, patient anxiety, and associated healthcare costs [1]. During the last decade of the 20th century, evidence demonstrated that cardiac troponin (cTn)T and cTnI have excellent cardiac tissue specificity, as well as high diagnostic accuracy for AMI compared to other biomarkers for assessing myocardial injury [2]. In 1999, the first Global Task Force was assembled and promulgated the consensus recommendation that cTn is the sole biomarker required for diagnosis of AMI [3]. This guidance has been consistent through development of the second [4], third [5], and, most recently in 2018, the fourth [6] Global Task force docum...
Source: Clinical Biochemistry - Category: Biochemistry Authors: Tags: Clin Biochem Source Type: research