Analytical Performance Evaluation of the Cardiac Troponin T High Sensitivity Gen 6 Assay

Authors

• Marko Knoll
• Lori B Daniels
• Christian Mueller
• Nicholas L Mills
• Evangelos Giannitsis
• Alisa F A Rösser
• Dunja Kurtoic
• Annika Wahl
• Richard Body
• Robert H Christenson
• Christa Cobbaert
• Christopher R deFilippi
• Kai M Eggers
• Kenji Inoue
• Allan S Jaffe
• Cian P McCarthy
• James McCord, Henry Ford HealthFollow
• Johannes T Neumann
• Torbjørn Omland
• Cynthia Papendick
• Yader Sandoval
• Jack Wei Chieh Tan
• Martin P Than
• Raphael Twerenbold
• W Frank Peacock
• Steven J R Meex

Recommended Citation

Knoll M, Daniels LB, Mueller C, Mills NL, Giannitsis E, Rösser AFA, Kurtoic D, Wahl A, Body R, Christenson RH, Cobbaert C, deFilippi CR, Eggers KM, Inoue K, Jaffe AS, McCarthy CP, McCord J, Neumann JT, Omland T, Papendick C, Sandoval Y, Tan JWC, Than MP, Twerenbold R, Peacock WF, Meex SJR. Analytical Performance Evaluation of the Cardiac Troponin T High Sensitivity Gen 6 Assay. J Appl Lab Med. 2026.

Document Type

Article

Publication Date

3-26-2026

Publication Title

J Appl Lab Med

Abstract

BACKGROUND: High-sensitivity cardiac troponin (hs-cTn) assays are recommended for the diagnosis of acute myocardial infarction. Here, we characterize the analytical performance of a next-generation hs-cTn assay, Elecsys® Troponin T hs Gen 6 (Roche Diagnostics International).

METHODS: Surplus lithium-heparin plasma or serum samples from patients or healthy volunteers were run on Cobas® e 801, e 402, and Pro analyzers. Limits of blank (LoB), limits of detection (LoD), and limits of quantitation (LoQ) were determined according to CLSI EP17-A2, with target values of 1.0 and 1.5 ng/L for LoB/LoD and 3.0 ng/L (10% CV) and 1.5 ng/L (20% CV) for LoQ, respectively. Precision was measured, per CLSI EP17-A2, using 3 QC samples (approximately 4, 30, and 220 ng/L), 12 native samples, and 3 reagent lots. Linearity, per CLSI EP06-Ed2, was determined by diluting samples with cardiac troponin T (cTnT) concentration above the measuring range with a low/blank sample. Interference (per Glick) with endogenous and assay components at 5 cTnT concentrations was assessed.

RESULTS: Measured values for LoB, LoD, and LoQ at 10% and 20% CV were 0.1 to 0.7 ng/L, 0.3 to 1.4 ng/L, 1.0 to 2.9 ng/L, and 0.4 to 1.2 ng/L, respectively. Repeatability CVs were 1.0 to 5.8% for mean cTnT concentrations of 2.6 to 9230 ng/L in lithium-heparin plasma. High precision was shown across lots, and linearity was observed across the measuring range (1.5 to 9500 ng/L, all Pearson's r = 1.00). No interferences were observed, specified up to ≤1000 mg/dL hemoglobin, ≤50 mg/dL [≤855 µmol/L] icterus/bilirubin, and ≤1200 ng/mL biotin.

CONCLUSIONS: The analytical performance characterization of the assay demonstrated high sensitivity, high precision at the low end and across the measuring range, and resistance to interference.

PubMed ID

41885135

ePublication

ePub ahead of print