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

Abstract 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.