Abstract
BackgroundAlthough LDL-C has been traditionally estimated using the Friedewald formula (FF), several direct homogeneous assays have been developed to overcome the limitations of this formula and the complicated manual procedure required in the reference method. However, several differences have been reported between these assays in certain situations. MethodsTwo 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. ResultsStatistical 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. ConclusionsOur 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.
Published Version
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