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Coronary disease & ACSDiagnostic or prognostic study

Diagnostic validation of a novel high-sensitivity cardiac troponin T assay

Eur Heart J Acute Cardiovasc CarePublished

  • Diagnostic and prognostic evaluation; patients prospectively evaluated
  • prospective
  • head-to-head comparisons between the new and established assays
  • adjusted Cox regression
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Authors' 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)

Study context

Population
Patients presenting to the emergency department with suspected non-ST-elevation myocardial infarction (MI)mean age 64 years and 64.2% male, MI diagnosed in 12.1%
Participants
1,415 patients
Comparison
Novel hs-cTnT assay against MI diagnosis, using previously derived cut-off concentrations and ESC 0/1 h algorithm; head-to-head with established assays

Performance

As reported in the abstract

Discrimination for MI (AUC) · admission and 1 h

AUC on admission

0.87 (95% CI: 0.84, 0.90)

AUC after 1 h

0.91 (95% CI: 0.89, 0.93)

Further findings

Prognosis: association of hs-cTnT with 1-year mortality and MACE

ComparisonHR (95% CI)
Hs-cTnT · 1-year mortality; adjusted Cox regression1.39 (1.28–1.51)
Hs-cTnT · MACE; adjusted Cox regression1.22 (1.15–1.29)

Rule-out (0 h cut-off <8 ng/L or <18 ng/L and Δ 0/1 h of <2 ng/L) · 0/1 h

Rule-out
54.3% (95% CI: 51.7%, 57.0%)
NPV
99.5% (95% CI: 98.7%, 99.9%)
Sensitivity
97.7% (95% CI: 94.1%, 99.4%)

Rule-in (0 h cut-off ≥112 ng/L or Δ 0/1 h ≥ 10 ng/L) · 0/1 h

PPV
58.5% (95% CI: 51.9%, 64.9%)
Specificity
92.2% (95% CI: 90.6%, 93.6%)
Rule-in
16.5% (95% CI: 14.6%, 18.6%)

Original publication

Diagnostic validation of a novel high-sensitivity cardiac troponin T assay. Eur Heart J Acute Cardiovasc Care. Published 20 April 2026. doi:10.1093/ehjacc/zuag044
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Summarised from the published abstract; every number is checked against it