Clinical derivation and data simulated validation of rule-out and rule-in algorithms for the Siemens Atellica IM high-sensitivity cardiac troponin I assay
Authors' conclusion
This study presents Siemens Atellica hs-cTnI algorithms for diagnosis and risk prediction in the ED with performance comparable with established hs-cTnT (Roche) and hs-cTnI (Abbott) algorithms.
Study context
- Population
- Patients in the emergency department (ED)derivation cohort, validated using a synthetic data set with nearly 1 million patient cases
- Participants
- 1,896 patients
- Exposure
- Siemens Atellica IM high-sensitivity cardiac troponin I (hs-cTnI) algorithms compared with the European Society of Cardiology algorithms for hs-cTnT (Roche Diagnostics) and hs-cTnI (Abbott Diagnostics)
- Outcome
- 30-day MI or death, admission hs-cTnI concentration < 5 ng/L
- Follow-up
- 30-day
Methodological detailssynthetic data set validation
- Synthetic data set validation
Main finding
As reported in the abstract
NPV
99.5-99.7%
Sensitivity
98.1-98.8%
Observational data: associations, not effects.
Further findings
Ruling out index non-ST-elevation MI (NSTEMI), admission hs-cTnI concentration < 5 ng/L
- NPV
- ≥99.7%
- Sensitivity
- ≥98.8%
0- to 1-h algorithm (baseline hs-cTnI < 10 ng/L and Δ change < 3 ng/L), 30-day myocardial infarction (MI) or death
- NPV
- ≥99.5%
- Sensitivity
- ≥ 97.3%
0- to 1-h algorithm (baseline hs-cTnI < 10 ng/L and Δ change < 3 ng/L), index NSTEMI · index admission
- Sensitivity and NPV
- ≥99.5%
Rule-in algorithms (0-h hs-cTnI ≥ 120 ng/L or 0- to 1-h Δ change ≥ 12 ng/L), 30-day MI or death and index NSTEMI
- Positive predictive value
- ≥ 73%
- Specificity
- > 96%
Comparison with established hs-cTn algorithms
- The results were comparable with established hs-cTn algorithms
Original publication
Summarised from the published abstract; every number is checked against it