Clinical performance evaluation of VITROS High-sensitivity Troponin I reagent

<p>Cardiac troponin I is a well-known selective marker of myocardial injury, and its concentration relative to the 99th percentile values of healthy subjects can predict the presence of myocardial damage. Because the high-sensitivity troponin assay is recommended by Acute Coronary Syndrome Guidelines (2018), we evaluated the performance of VITROS High-sensitivity Troponin I in this study and compared it with other high-sensitivity reagents. We obtained good results in terms of repeatability, with coefficient of variation (CV) values between 0.86% and 2.44% as well as CV values of 2.19%–4.57% for precision between days. Interference by unconjugated bilirubin occurred in a concentration-dependent decreasing trend, whereas the influence of other substances was insignificant. The correlation coefficient and 99th percentile agreement between the AIA PACK CL Troponin I were r = 0.983 and y = 0.738x − 3.39 and 92.1%, respectively, showing a good correlation. With Elecsys reagent High-sensitivity Troponin T, the respective values were r = 0.789 and y = 3.149x − 60.969 and 86.7%. Because there was a tendency of divergence around the 99th percentile value when comparing each reagent, clinical judgment based on troponin results should be considered in addition to other examination results, such as electrocardiogram. Nonetheless, VITROS High-sensitivity Troponin I was found to be the most disease specific and highly specific for acute myocardial infarction, a disease that requires immediate diagnosis.</p>