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

Area of Science:

• Clinical Chemistry
• Biostatistics
• Hematology

Background:

• Accurate measurement uncertainty (MU) is crucial for reliable laboratory diagnostics.
• Factor assays in coagulation testing are subject to various sources of variability.
• Quantifying MU is essential for interpreting test results and clinical decision-making.

Purpose of the Study:

• To quantify the measurement uncertainty (MU) for coagulation factor activities using Monte Carlo simulation (MCS).
• To compare MCS-derived MU with results from the top-down approach.
• To evaluate the suitability of MCS for factor assays across the measurement range.

Main Methods:

• Monte Carlo simulation (MCS) was employed to model uncertainties for Factor V (FV), Factor VIII (FVIII), and Factor X (FX) activities.
• Simulations were performed using data from two distinct coagulation testing systems: ACL TOP 750 CTS and STA Compact.
• MCS-derived MUs were compared against MUs obtained via the top-down approach using actual patient samples.

Main Results:

• Specific MUs were determined for FV, FVIII, and FX on both platforms, with notable differences between the ACL TOP and STA Compact systems.
• For instance, at specified factor activities, MUs for FV were 3.5% (ACL TOP) and 8.5% (STA Compact).
• MCS MU results demonstrated interchangeability with the top-down approach, with a minor exception for FVIII on the STA Compact.

Conclusions:

• Monte Carlo simulation (MCS) is a robust and suitable method for quantifying measurement uncertainty in factor assays.
• The findings suggest MCS can provide reliable MU estimations across the entire measurement range of these assays.
• This supports the use of MCS for improving the accuracy and reliability of coagulation testing.