External validation of the 0/1h-algorithm and derivation of a 0/2h-algorithm using a new point-of-care Hs-cTnI assay
Authors' conclusion
The POC hs-cTnI-PATHFAST assay allows rapid and effective rule-out and rule-in of NSTEMI using both a 0/1h- and a 0/2h-algorithm with high NPV/sensitivity for rule-out and high PPV/specificity for rule-in.
Study context
- Population
- Patients presenting to the ED with acute chest discomfort; final diagnoses centrally adjudicated using serial hs-cTnI-ArchitectNSTEMI in 13%
- Participants
- 1,532 patients
- Comparison
- hs-cTnI-PATHFAST 0/1h-algorithm and 0/2h-algorithm for NSTEMI rule-out and rule-in
- Outcome
- Diagnostic performance (NPV, sensitivity for rule-out; PPV, specificity for rule-in) for NSTEMI
Methodological detailsmulticentre, external validation, derivation and validation, Final diagnoses centrally adjudicated by two independent cardiologists
- Multicentre
- External validation
- Derivation and validation
- Final diagnoses centrally adjudicated by two independent cardiologists
Performance
As reported in the abstract
NSTEMI rule-out and rule-in
| Test or model | NPV (rule-out) | Sensitivity (rule-out) | PPV (rule-in) | Specificity (rule-in) | Ruled out | Ruled in |
|---|---|---|---|---|---|---|
| 0/1h-algorithm | 100% (95%CI, 99.5%-100%) | 100% (95%CI, 98.2%-100%) | 74.9% (95%CI, 68.3%-80.5%) | 96.4% (95%CI, 95.2%-97.3%) | ||
| 0/2h-algorithm | 100% (95%CI, 98-100) | 100% (95%CI, 92.9%-100%) | 81.6% (95%CI, 66.6-90.8) | 97.7% (95%CI, 95.4-98.9%) | 52% | 38 patients (11%) |
NPV (rule-out)
0/1h-algorithm100% (95%CI, 99.5%-100%)
0/2h-algorithm100% (95%CI, 98-100)
Sensitivity (rule-out)
0/1h-algorithm100% (95%CI, 98.2%-100%)
0/2h-algorithm100% (95%CI, 92.9%-100%)
PPV (rule-in)
0/1h-algorithm74.9% (95%CI, 68.3%-80.5%)
0/2h-algorithm81.6% (95%CI, 66.6-90.8)
Specificity (rule-in)
0/1h-algorithm96.4% (95%CI, 95.2%-97.3%)
0/2h-algorithm97.7% (95%CI, 95.4-98.9%)
Ruled out
0/1h-algorithm— not stated in the abstract
0/2h-algorithm52%
Ruled in
0/1h-algorithm— not stated in the abstract
0/2h-algorithm38 patients (11%)
Original publication
External validation of the 0/1h-algorithm and derivation of a 0/2h-algorithm using a new point-of-care Hs-cTnI assay. Am Heart J. Published 1 December 2023. doi:10.
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