Key result
Novel hs-cTnT algorithm safely rules out NSTEMI in ~42% of patients with high accuracy.
Why the study?
The ESC 0/1-hour algorithm for suspected NSTEMI is assay-dependent, and clinical data defining specific 0/1-hour cut-offs and diagnostic performance for alternative hs-cTnT platforms are lacking.
Does a novel high-sensitivity cardiac troponin T assay accurately and safely diagnose NSTEMI using the ESC 0/1-hour algorithm in adult patients presenting with symptoms suggestive of acute coronary syndrome?
Observational (n=397)
No
Does a novel high-sensitivity cardiac troponin T assay accurately and safely diagnose NSTEMI using the ESC 0/1-hour algorithm in adult patients presenting with symptoms suggestive of acute coronary syndrome?
This prospective study demonstrates that a novel hs-cTnT assay correlates strongly with the reference assay and meets ESC safety standards (NPV 99.4%) for rapid 0/1-hour rule-out of NSTEMI.
Supports rapid 0/1h NSTEMI rule-out with novel hs-cTnT in this cohort; leaves open multicenter validation before wider adoption.
Background The European Society of Cardiology (ESC) 0/1-hour algorithm is recommended for the rapid triage of patients with suspected non-ST-elevation myocardial infarction (NSTEMI). While this strategy is well-established for the reference high-sensitivity cardiac troponin T (hs-cTnT) assay, the algorithm is assay-dependent, and clinical data defining specific 0/1-hour cut-offs for alternative platforms are currently lacking. Purpose This study evaluated the diagnostic performance and safety of a novel hs-cTnT assay within this clinical protocol. Methods In this prospective, single-center study at a general hospital, 397 adult patients presenting with symptoms suggestive of acute coronary syndrome were enrolled. The final diagnosis of NSTEMI was adjudicated by two independent cardiologists based on ESC guidelines. We assessed the correlation between the novel hs-cTnT assay and the established reference assay and derived optimal cut-offs for a 0/1h algorithm. Results NSTEMI was diagnosed in 11.6% of the population. The novel assay showed an excellent correlation with the reference assay (R2=0.995). At presentation (0h), the AUC-ROC for NSTEMI diagnosis was 0.94 (95% CI: 0.90–0.98). The derived 0/1h rule-out criteria (0h < 5 ng/L if onset > 3h, or 0h < 12 ng/L and 1h-delta < 2 ng/L) triaged 41.7% of patients with a Negative Predictive Value (NPV) of 99.4% and sensitivity of 97.0%. The rule-in criteria (0h ≥ 57 ng/L or 1h-delta ≥ 7 ng/L) identified 17.1% of patients with a Positive Predictive Value (PPV) of 56.0% and specificity of 92.1%. The 30-day all-cause mortality in the rule-out group was 0.9%, and the MACE rate was 0.96%. Conclusions The novel hs-cTnT assay is safe and effective for use in the ESC 0/1-hour algorithm. It successfully meets the ESC safety requirement (NPV > 99%) for rapid rule-out, making it a viable and promising platform for emergency department triage of suspected NSTEMI.
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Nguyen et al. (2026) conducted an observational in Suspected non-ST-elevation myocardial infarction (NSTEMI) (n=397). Novel hs-cTnT assay in the ESC 0/1-hour algorithm vs. Established reference hs-cTnT assay was evaluated on Diagnostic accuracy and safety (NPV for rule-out and AUC-ROC) for NSTEMI diagnosis (AUC 0.94, 95% CI 0.90-0.98). The novel hs-cTnT assay in the ESC 0/1-hour algorithm safely ruled out NSTEMI in 41.7% of patients with a 99.4% NPV, 97.0% sensitivity, and 0.94 AUC (95% CI 0.90-0.98).
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