Estimating the measurement uncertainties of the Abbott Alinity i high-sensitivity cardiac troponin I assay through Monte Carlo simulation

Background Estimating measurement uncertainty (MU) for high-sensitivity cardiac troponin I (hs-cTnI) is challenging due to complex calibration requirements. We aimed to quantify the MU of hs-cTnI (Abbott, IL, USA) using Monte Carlo simulation (MCS), a computational algorithm that simulates statistical sampling to achieve numerical results through rigorous mathematical calculations. Methods Precision profiling of the instrumental signal across the analytical range was performed using internal quality control data. Subsequently, four-parameter logistic-log calibration models were simulated in each MCS trial. The MU of hs-cTnI corresponding to each instrumental signal was estimated using MCS. Results As hs-cTnI concentrations increased, the MU gradually decreased, reaching its lowest value of 15.3% at 577.9 ng/L. MU values at clinical decision cutoff points were 23.6% (15.6 ng/L for women) and 20.0% (34.2 ng/L for men). Conclusions Using MCS, we estimated the MU of hs-cTnI across its entire measurement range, with MU values ranging approximately from 15% to 25% depending on the hs-cTnI concentration. The results should be interpreted with caution, especially near clinical decision points where uncertainty may be higher.