Coronary disease & ACSDiagnostic or prognostic study
Clinical and Analytical Performance of a Novel Point-of-Care High-Sensitivity Cardiac Troponin I Assay
- Diagnostic accuracy study
- international
- multicentre
Final diagnosis centrally adjudicated by 2 independent cardiologists
Authors' conclusion
The SPINCHIP hs-cTnI POC test has very high diagnostic accuracy. Its assay-specific 0/1-hour algorithm achieved very high sensitivity/negative predictive value and specificity/positive predictive value for rule-out/in MI.
Study context
- Population
- Adults presenting to the ED with acute chest discomfortMyocardial infarction (MI) in 214 (19%)
- Participants
- 1,102 adults
- Comparison
- hs-cTnI-SPINCHIP point-of-care (POC) vs central laboratory assays
- Outcome
- Diagnostic performance (AUC) for centrally adjudicated MI
Performance
As reported in the abstract
AUC for MI
| Test or model | AUC |
|---|---|
| hs-cTnI-SPINCHIP | 0.94 (95% CI: 0.92-0.95) |
| hs-cTnI-Architect | 0.94 (95% CI: 0.92-0.95) |
| hs-cTnT Elecsys | 0.93 (95% CI: 0.91-0.95) |
- hs-cTnI-SPINCHIP vs hs-cTnI-Architect: P = 0.907
- hs-cTnI-SPINCHIP vs hs-cTnT Elecsys: P = 0.305
Further findings
| Outcome | Values |
|---|---|
| hs-cTnI-SPINCHIP 0/1-h algorithm | hs-cTnI-SPINCHIP Ruled out (<7 ng/L at presentation if onset >3 h, or <7 ng/L with 0/1-h delta <4 ng/L) 51% · Sensitivity 100% (95% CI: 97.7%-100%) · NPV 100% (95% CI: 99.0%-100%) · Ruled in (≥36 ng/L or 0/1-h delta ≥11 ng/L) 27% · Specificity 90.9% (95% CI: 88.3%-92.9%) · PPV 72.9% (95% CI: 66.4%-78.6%) |
hs-cTnI-SPINCHIP 0/1-h algorithm
- Bootstrap internal validation confirmed excellent diagnostic performance
Sample type comparison (whole blood, fresh/frozen plasma, capillary finger prick)
- High agreement between sample types
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Clinical and Analytical Performance of a Novel Point-of-Care High-Sensitivity Cardiac Troponin I Assay. J Am Coll Cardiol. Published 20 August 2024. doi:10.1016/j.jacc.2024.05.056
Summarised from the published abstract; every number is checked against it