Journal of the American College of Cardiology · 2026
High-Sensitivity Cardiac Troponin T-gen6 Assay in Suspected Myocardial Infarction: Diagnostic Accuracy, Cutoffs, and Clinical Implications.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Koechlin Luca, Lopez-Ayala Pedro, Thurston Alexander J F, Tew Yong Yong, O'Brien Rachel, Gray Alasdair, Bima Paolo, Kaplan Emel, Miró Òscar, Christ Michael, Keller Dagmar I, Martin-Sanchez Javier F, Morawiec Beata, Parenica Jiri, Herraiz Recuenco Lourdes, Huré Gabrielle, Wildi Karin, Crisanti Luca, Spagnuolo Carlos, Glaeser Jonas, Caubergh Catherine, Rentsch Katharina, Slankamenac Ksenija, Rodriguez Cetina Biefer Héctor, Dzemali Omer, Strebel Ivo, Mahfoud Felix, Mills Nicholas L, Boeddinghaus Jasper, Mueller Christian, APACE and POC-ET Investigators
Аннотация
BACKGROUND: The new high-sensitivity cardiac troponin (hs-cTn) T-generation (gen) 6 assay has higher analytical sensitivity than the current hs-cTnT-gen5 assay, but its clinical performance is unknown.
OBJECTIVES: The authors aimed to assess the clinical performance and use-optimized cutoffs of the hs-cTnT-gen6 assay.
METHODS: In this secondary analysis of an international, prospective, diagnostic study with central adjudication, patients presenting with suspected myocardial infarction to the emergency department were enrolled. hs-cTnT-gen6 and hs-cTnT -gen5 were measured at the same time points. The analytical and diagnostic performance of hs-cTnT-gen6 were compared to hs-cTnT-gen5, and assay-specific cutoffs for the European Society of Cardiology 0/1- and 0/2-hour algorithms were derived and internally and externally validated.
RESULTS: Among 3,346 patients, myocardial infarction was the final diagnosis in 616 (18.4%). The proportion of patients with concentrations above the upper reference limit and therefore having myocardial injury was lower for hs-cTnT-gen6 (35.9%) than for hs-cTnT-gen5 (43.5%; P < 0.001). Diagnostic accuracy at emergency department presentation, expressed as area under the curve, was 0.927 (95% CI: 0.918-0.937) for hs-cTnT-gen6 and 0.931 (95% CI: 0.921-0.94) for hs-cTnT-gen5. A gen6 cutoff of <6 ng/L ruled out non-ST-segment elevated myocardial infarction in 30.0% of patients with 100% sensitivity (95% CI: 99.4%-100%) irrespective of chest pain onset. An hs-cTnT-gen6 cutoff of <8 ng/L at presentation (if chest pain onset was >3 hours) or <18 ng/L together with a 0/1-hour delta of <2 ng/L ruled out 56.3% with a sensitivity of 99.7% (95% CI: 98.3%-99.9%). An hs-cTnT-gen6 concentration ≥112 ng/L or a 0/1-hour delta ≥10 ng/L ruled-in 20.0% with a specificity of 93.4% (95% CI: 92.0%-94.6%). An hs-cTnT-gen6 cutoff <8 ng/L at presentation (if chest pain onset was >3 hours) or <18 ng/L together with a 0/2-hour delta of <4 ng/L ruled out 51.1% with a sensitivity of 99.7% (95% CI: 98.1%-99.9%). An hs-cTnT-gen6 concentration ≥112 ng/L or a 0/2-hour delta ≥15 ng/L ruled-in 23.9% with a specificity 92.7% (95% CI: 90.8%-94.2%). Findings were consistent in sensitivity analyses as well as in the external validation cohort.
CONCLUSIONS: The novel hs-cTnT-gen6 assay demonstrated excellent and comparable diagnostic performance to the established hs-cTnT-gen5 assay with fewer patients identified as having myocardial injury. Use-optimized, assay-specific cutoffs for the European Society of Cardiology 0/1- and 0/2-hour algorithms provided very high sensitivity and high specificity. (Advantageous Predictors of Acute Coronary Syndromes Evaluation Study [APACE]; NCT00470587).
OBJECTIVES: The authors aimed to assess the clinical performance and use-optimized cutoffs of the hs-cTnT-gen6 assay.
METHODS: In this secondary analysis of an international, prospective, diagnostic study with central adjudication, patients presenting with suspected myocardial infarction to the emergency department were enrolled. hs-cTnT-gen6 and hs-cTnT -gen5 were measured at the same time points. The analytical and diagnostic performance of hs-cTnT-gen6 were compared to hs-cTnT-gen5, and assay-specific cutoffs for the European Society of Cardiology 0/1- and 0/2-hour algorithms were derived and internally and externally validated.
RESULTS: Among 3,346 patients, myocardial infarction was the final diagnosis in 616 (18.4%). The proportion of patients with concentrations above the upper reference limit and therefore having myocardial injury was lower for hs-cTnT-gen6 (35.9%) than for hs-cTnT-gen5 (43.5%; P < 0.001). Diagnostic accuracy at emergency department presentation, expressed as area under the curve, was 0.927 (95% CI: 0.918-0.937) for hs-cTnT-gen6 and 0.931 (95% CI: 0.921-0.94) for hs-cTnT-gen5. A gen6 cutoff of <6 ng/L ruled out non-ST-segment elevated myocardial infarction in 30.0% of patients with 100% sensitivity (95% CI: 99.4%-100%) irrespective of chest pain onset. An hs-cTnT-gen6 cutoff of <8 ng/L at presentation (if chest pain onset was >3 hours) or <18 ng/L together with a 0/1-hour delta of <2 ng/L ruled out 56.3% with a sensitivity of 99.7% (95% CI: 98.3%-99.9%). An hs-cTnT-gen6 concentration ≥112 ng/L or a 0/1-hour delta ≥10 ng/L ruled-in 20.0% with a specificity of 93.4% (95% CI: 92.0%-94.6%). An hs-cTnT-gen6 cutoff <8 ng/L at presentation (if chest pain onset was >3 hours) or <18 ng/L together with a 0/2-hour delta of <4 ng/L ruled out 51.1% with a sensitivity of 99.7% (95% CI: 98.1%-99.9%). An hs-cTnT-gen6 concentration ≥112 ng/L or a 0/2-hour delta ≥15 ng/L ruled-in 23.9% with a specificity 92.7% (95% CI: 90.8%-94.2%). Findings were consistent in sensitivity analyses as well as in the external validation cohort.
CONCLUSIONS: The novel hs-cTnT-gen6 assay demonstrated excellent and comparable diagnostic performance to the established hs-cTnT-gen5 assay with fewer patients identified as having myocardial injury. Use-optimized, assay-specific cutoffs for the European Society of Cardiology 0/1- and 0/2-hour algorithms provided very high sensitivity and high specificity. (Advantageous Predictors of Acute Coronary Syndromes Evaluation Study [APACE]; NCT00470587).