Two groups of 105 samples with extreme low and high HDL-C concentrations were processed, employing four different instruments and with the reagents for total cholesterol, triglycerides, HDL-C and LDL-C provided by the distinct manufacturers.
Statistical tests indicated important differences between HDL-C and LDL-C homogeneous methods. Poor correlation, significant bias and high discrepancy in cardiovascular disease risk classification were observed for LDL-C direct assays in the low HDL-C group, whereas better results were obtained when comparing LDL-C levels estimated with the FF. In contrast, three of the four instruments generated LDL-C direct results with a good agreement in the high HDL-C group, even though an appreciable misclassification percentage in risk categories must be taken into account.
Our results indicate that extreme low or high HDL-C levels can represent a non-previously described source of variation between commercially available LDL-C homogeneous assays.