Analytical performance of the Roche Elecsys TnT hs Gen 6 immunoassay

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.