Coronary disease & ACSSecondary analysis

High-Sensitivity Cardiac Troponin T-gen6 Assay in Suspected Myocardial Infarction

J Am Coll CardiolPublished

  • Secondary analysis of the APACE prospective diagnostic study
  • international
  • central adjudication
  • internal and external validation

Authors' conclusion

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.

Study context

Population
Patients presenting to the ED with suspected MIMI in 616 (18.4%)
Participants
3,346 patients
Comparison
hs-cTnT-gen6 vs hs-cTnT-gen5 assay
Primary endpoint
Clinical (analytical and diagnostic) performance and use-optimized cutoffs for the ESC 0/1- and 0/2-hour algorithms

Primary result

As reported in the abstract

Diagnostic accuracy at ED presentation (AUC) and myocardial injury (concentration above upper reference limit) · ED presentation
GroupAUCMyocardial injury
hs-cTnT-gen60.927 (95% CI: 0.918-0.937)35.9%
hs-cTnT-gen50.931 (95% CI: 0.921-0.94)43.5%
  • hs-cTnT-gen6 vs hs-cTnT-gen5: P < 0.001 — myocardial injury 35.9% vs 43.5%

Further findings

Myocardial injury (concentration above upper reference limit)

P < 0.001

ESC 0/1-hour algorithm with hs-cTnT-gen6 cutoffs (rule-out <8 ng/L if onset >3 h or <18 ng/L with delta <2 ng/L; rule-in ≥112 ng/L or delta ≥10 ng/L)
56.3% · Ruled out · Sensitivity 99.7% (95% CI: 98.3%-99.9%) · Ruled in 20.0% · Specificity 93.4% (95% CI: 92.0%-94.6%)
ESC 0/2-hour algorithm with hs-cTnT-gen6 cutoffs (rule-out <8 ng/L if onset >3 h or <18 ng/L with delta <4 ng/L; rule-in ≥112 ng/L or delta ≥15 ng/L)
51.1% · Ruled out · Sensitivity 99.7% (95% CI: 98.1%-99.9%) · Ruled in 23.9% · Specificity 92.7% (95% CI: 90.8%-94.2%)
  • ESC 0/2-hour algorithm with hs-cTnT-gen6 cutoffs (rule-out <8 ng/L if onset >3 h or <18 ng/L with delta <4 ng/L; rule-in ≥112 ng/L or delta ≥15 ng/L): Consistent in sensitivity analyses and external validation cohort

Single gen6 cutoff <6 ng/L at presentation, NSTEMI rule-out

Ruled out, irrespective of chest pain onset
30.0%
Sensitivity
100% (95% CI 99.4%-100%)

Original publication

High-Sensitivity Cardiac Troponin T-gen6 Assay in Suspected Myocardial Infarction. J Am Coll Cardiol. Published 25 March 2026. doi:10.1016/j.jacc.2025.12.052

Summarised from the published abstract; every number is checked against it