Bias between enzymatic methods and the reference method for cholesterol.

Assaying 312 serum samples, we compared four enzymatic methods for serum cholesterol with the Reference Method (modified Abell-Kendall) of the Centers for Disease Control (CDC). The means for the aca, TDx, and SMAC methods (2.27, 2.27, and 2.24 g/L, respectively) were significantly higher (P less than 0.05) than those of the Reference Method and the RA-1000 method (2.19 and 2.18 g/L, respectively). The biased methods had positive proportional and (or) systematic biases. Results with these methods were 2.6% to 4.9% higher than with the Reference Method. The assigned concentrations of cholesterol in the calibration materials for the SMAC and aca agreed with those obtained by the Reference Method, but were lower for the TDx and higher for the RA-1000. These findings document positive biases for cholesterol with three enzymatic methods and suggest that misassignment of calibrators is not primarily responsible for the biases found with the aca and SMAC. It may, however, to be a significant factor for the TDx.