Analytical performance of the Roche Elecsys TnT hs Gen 6 immunoassay

Abstract Objectives The acute coronary syndrome (ACS) is a leading cause of morbidity and mortality worldwide, with timely diagnosis being critical for improving outcomes. Since high-sensitivity cardiac troponin (hs-cTn) assays have become the gold standard for detecting myocardial injury, this study aimed to evaluate the analytical performance of the novel Roche Elecsys TnT hs Gen 6 (TNT6ST) immunoassay. Methods The TNT6ST immunoassay was assessed for intra- and inter-assay imprecision, linearity, limit of blank (LoB), limit of detection (LoD), functional sensitivity, and 99th percentile upper reference limit (URL). Comparisons were made with the previous Elecsys hs-cTnT immunoassay (TNTHSSTX). Hemolysis interference was evaluated in plasma samples with serially induced hemolysis. Results TNT6ST exhibited excellent precision (intra-assay CV 0.8–2.0 %, inter-assay 1.5–2.4 %), linearity (r=1.00), LoB of 0.939 ng/L, LoD of 1.201 ng/L, and functional sensitivity of 1.255 ng/L. The 99th percentile URL was 20.9 ng/L overall, 30.5 ng/L in males, and 13.7 ng/L in females. Comparison with TNTHSSTX showed strong correlation (r=0.995) but a systematic bias, with TNT6ST overestimating cTnT by around 66 %. Hemolysis decreased cTnT values in both assays, but TNT6ST remained within the allowable total error, while TNTHSSTX exceeded this threshold at higher hemolysis levels. Conclusions The novel Roche TNT6ST immunoassay demonstrates superior precision, sensitivity, and robustness to hemolysis compared with its predecessor, with excellent correlation across a wide cTnT range, supporting its reliability for introduction into routine clinical practice.