Estimation of Measurement Uncertainty of Factor Assays Using the Monte Carlo Simulation

Objectives: We aimed to quantify the measurement uncertainty (MU) for factor activities using the Monte Carlo simulation (MCS), which is a computational algorithm that simulates statistical sampling to obtain numerical results through complex mathematical calculations. Methods: The uncertainties of factor V (FV), factor VIII (FVIII), and factor X (FX) were simulated with two coagulation testing systems: ACL TOP 750 CTS (Instrumentation Laboratory) and STA Compact (Diagnostica Stago). Results: When the factor activities were 74% (FV), 68% (FVIII), and 89% (FX), the MUs were 3.5% (FV), 9.3% (VIII), and 2.8% (FX) for ACL TOP and 8.5% (FV), 18.2% (FVII), and 6.5% (FX) for STA Compact. MCS MUs were compared with MUs obtained from running actual samples (not simulated) using a method called the top-down approach. The MCS MU results were interchangeable with MUs from the top-down approach, except for FVIII from STA Compact. Conclusions: The MCS procedure is well suited for the quantification of MUs for factor assays over the entire measurement range.