Diagnostic discrimination of a novel high-sensitivity cardiac troponin I assay and derivation/validation of an assay-specific 0/1h-algorithm
Authors' conclusion
The overall performance of the hs-cTnI-EXL was comparable to best-validated hs-cTnT/I assays and an assay-specific 0/1h-algorithm safely rules out and accurately rules in acute MI.
Study context
- Population
- Patients presenting to the ED with chest discomfort204 [14%] with myocardial infarction (MI)
- Participants
- 1,454 patients
- Comparison
- hs-cTnI-EXL vs hs-cTnI-Architect vs hs-cTnT-Elecsys
- Outcome
- Discriminatory performance (AUC) for acute MI
Methodological detailsmulticentre, central adjudication by two cardiologists, derivation and validation cohorts
- Multicentre
- Central adjudication by two cardiologists
- Derivation and validation cohorts
Performance
As reported in the abstract
AUC for acute MI
| Test or model | AUC |
|---|---|
| hs-cTnI-EXL | 0.94 (95%CI, 0.93-0.96) |
| hs-cTnI-Architect | 0.95 (95%CI, 0.93-0.96) |
| hs-cTnT-Elecsys | 0.93 (95%CI, 0.91-0.95) |
AUC
hs-cTnI-EXL0.94 (95%CI, 0.93-0.96)
hs-cTnI-Architect0.95 (95%CI, 0.93-0.96)
hs-cTnT-Elecsys0.93 (95%CI, 0.91-0.95)
Further findings
Assay-specific 0/1h-algorithm, validation cohort (n = 345)
- Ruled out
- 56%
- NPV
- 99.5% (95%CI, 97.1-99.9)
- Sensitivity
- 97.8% (95%CI, 88.7-99.6)
- Ruled in
- 9%
- PPV
- 83.3% (95%CI, 66.4-92.7)
- Specificity
- 98.3% (95%CI, 96.1-99.3)
- Derivation cohort n = 813: rule-out <9ng/L at presentation (if chest pain onset >3h) or <9ng/L and 0h-1h-change <5ng/L; rule-in ≥160ng/L at presentation or 0h-1h-change ≥100ng/L
Secondary analysis: adjudication based on hs-cTnT
- Confirmed the findings
Original publication
Diagnostic discrimination of a novel high-sensitivity cardiac troponin I assay and derivation/validation of an assay-specific 0/1h-algorithm. Am Heart J. Published 13 October 2022. doi:10.
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