European heart journal. Acute cardiovascular care · 2026
Diagnostic validation of a novel high-sensitivity cardiac troponin T assay.
СтатьяВалидационное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Völschow Ben, Strauß Bianca, Sörensen Nils Arne, Thießen Niklas, Lehmacher Jonas, Toprak Betül, Abdennadher Beya, Dehkordi Farnaz, Haller Paul M, Scharlemann Lea, Schock Alina, Petersmann Astrid, Gauß Friederike, Twerenbold Raphael, Neumann Johannes T
Аннотация
AIMS: High-sensitivity cardiac troponin (hs-cTn) assays are integral to evaluating suspected myocardial infarction (MI). A recently developed hs-cTnT assay requires diagnostic and prognostic evaluation.
METHODS AND RESULTS: Patients presenting to the emergency department with suspected non-ST-elevation MI were prospectively evaluated. Discrimination was tested using the area under the curve (AUC). Diagnostic performance was assessed with previously derived cut-off concentrations and ESC 0/1 h algorithm. Head-to-head comparisons between the new and established assays were performed. Prognostic performance of hs-cTnT for 1-year mortality and major adverse cardiac events (MACE) was analysed using adjusted Cox regression. In 1415 patients, mean age 64 years and 64.2% male, MI was diagnosed in 12.1%. The novel TnT hs Gen 6 assay demonstrated excellent discrimination with an AUC on admission of 0.87 (95% CI: 0.84, 0.90) and 0.91 (95% CI: 0.89, 0.93) after 1 h. Using a 0 h cut-off <8 ng/L or <18 ng/L and Δ 0/1 h of <2 ng/L enabled rule-out in 54.3% (95% CI: 51.7%, 57.0%), with a NPV of 99.5% (95% CI: 98.7%, 99.9%); sensitivity was 97.7% (95% CI: 94.1%, 99.4%). For rule-in, a 0 h cut-off ≥112 ng/L or a Δ 0/1 h ≥ 10 ng/L yielded a PPV of 58.5% (95% CI: 51.9%, 64.9%) and specificity of 92.2% (95% CI: 90.6%, 93.6%) with rule-in of 16.5% (95% CI: 14.6%, 18.6%). Hs-cTnT was associated with 1-year mortality [hazard ratio (HR) 1.39 (95% CI: 1.28, 1.51)] and MACE [HR 1.22 (95% CI: 1.15, 1.29)].
CONCLUSION: The novel hs-cTnT assay demonstrates high diagnostic accuracy to rule-out or diagnose MI and offers valuable prognostic information regarding 1-year mortality and MACE.Trial Registration: clinicaltrials.gov (NCT02355457).
METHODS AND RESULTS: Patients presenting to the emergency department with suspected non-ST-elevation MI were prospectively evaluated. Discrimination was tested using the area under the curve (AUC). Diagnostic performance was assessed with previously derived cut-off concentrations and ESC 0/1 h algorithm. Head-to-head comparisons between the new and established assays were performed. Prognostic performance of hs-cTnT for 1-year mortality and major adverse cardiac events (MACE) was analysed using adjusted Cox regression. In 1415 patients, mean age 64 years and 64.2% male, MI was diagnosed in 12.1%. The novel TnT hs Gen 6 assay demonstrated excellent discrimination with an AUC on admission of 0.87 (95% CI: 0.84, 0.90) and 0.91 (95% CI: 0.89, 0.93) after 1 h. Using a 0 h cut-off <8 ng/L or <18 ng/L and Δ 0/1 h of <2 ng/L enabled rule-out in 54.3% (95% CI: 51.7%, 57.0%), with a NPV of 99.5% (95% CI: 98.7%, 99.9%); sensitivity was 97.7% (95% CI: 94.1%, 99.4%). For rule-in, a 0 h cut-off ≥112 ng/L or a Δ 0/1 h ≥ 10 ng/L yielded a PPV of 58.5% (95% CI: 51.9%, 64.9%) and specificity of 92.2% (95% CI: 90.6%, 93.6%) with rule-in of 16.5% (95% CI: 14.6%, 18.6%). Hs-cTnT was associated with 1-year mortality [hazard ratio (HR) 1.39 (95% CI: 1.28, 1.51)] and MACE [HR 1.22 (95% CI: 1.15, 1.29)].
CONCLUSION: The novel hs-cTnT assay demonstrates high diagnostic accuracy to rule-out or diagnose MI and offers valuable prognostic information regarding 1-year mortality and MACE.Trial Registration: clinicaltrials.gov (NCT02355457).