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Analytical performance of the Roche Elecsys TnT hs Gen 6 immunoassay
Marco Tosi1, Laura Pighi1,2, Claudia Lo Cascio2
1Section of Clinical Biochemistry, University of Verona, Verona, Italy.
Insights
The new Roche Elecsys TnT hs Gen 6 (TNT6ST) immunoassay shows improved precision and sensitivity for detecting cardiac injury. It also demonstrates better robustness against hemolysis interference compared to the previous version.
Area of Science:
- Clinical Chemistry
- Cardiovascular Diagnostics
- Immunoassay Technology
Background:
- Acute coronary syndrome (ACS) is a major global health concern requiring rapid diagnosis.
- High-sensitivity cardiac troponin (hs-cTn) assays are crucial for identifying myocardial injury.
- Evaluating novel diagnostic tools is essential for improving patient outcomes.
Purpose of the Study:
- To assess the analytical performance of the new Roche Elecsys TnT hs Gen 6 (TNT6ST) immunoassay.
- To compare the TNT6ST assay with the previous Elecsys hs-cTnT immunoassay (TNTHSSTX).
- To evaluate the impact of hemolysis on the performance of both assays.
Main Methods:
- Assessed intra- and inter-assay imprecision, linearity, LoB, LoD, functional sensitivity, and 99th percentile URL for TNT6ST.
- Compared TNT6ST performance against TNTHSSTX.
- Investigated hemolysis interference in plasma samples for both assays.
Main Results:
- TNT6ST demonstrated excellent precision (CVs 0.8-2.4%), linearity (r=1.00), and sensitivity (LoD 1.201 ng/L, functional sensitivity 1.255 ng/L).
- The 99th percentile URL was established (overall 20.9 ng/L, males 30.5 ng/L, females 13.7 ng/L).
- TNT6ST showed strong correlation (r=0.995) with TNTHSSTX but overestimated cTnT by ~66%; it also exhibited superior robustness to hemolysis.
Conclusions:
- The Roche TNT6ST immunoassay offers superior precision, sensitivity, and hemolysis robustness compared to its predecessor.
- The assay demonstrated excellent correlation across a wide cardiac troponin T range.
- These findings support the reliability of the TNT6ST assay for routine clinical use in diagnosing myocardial injury.
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.
