Improvements in accuracy and reproducibility of quantitative clotting factor assays by use of a novel approach for modeling reference curves.

A method for creating a reference model in the quantitative assay of specific clotting factor activities is described. This method incorporates the use of a piecewise function with two component polynomials. This function allows more accurate representation of the global coagulation reaction, a sequential activation of multiple serine protease enzymes and cofactors, leading to improvements over traditional methods in range, accuracy, precision and robustness in reported activity levels. Clotting factor assay results using this method are compared with traditional and other candidate methods.