[Fundamental Evaluation and Clinical Usefulness of Lipoprotein Analysis System with Anion-Exchange Chromatography]

We established a method for measurement of the cholesterol concentrations of high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), intermediate density lipoprotein cholesterol (IDL-C) and very low density lipoprotein cholesterol (VLDL-C) by using high performance liquid chromatography (HPLC) with anion-exchange column. The HPLC method has been covered by insurance in 2013, and HLC-729LPII (LPII) system constructed by this method has come on the market in 2014. We evaluated the fundamental precision data of lipoprotein cholesterol values measured by HLC-729 LPII. The within-day and between-day assay coefficients of variation of lipoprotein cholesterol values were 1.4-10.7 (%CV). The lipoprotein profiles of patients with type 2 diabetes mellitus (T2DM, n = 60) without dialysis therapy were measured by LPII. HDL-C obtained by LPII was highly correlated with that obtained by direct assay. LDL-C obtained by LPII was highly correlated with those obtained by direct assay and calculated by Friedewald's formula. In addition, IDL-C obtained by LPII was negatively correlated with estimated Glomerular Filtration Ratio (eGFR). These results suggest that the new HPLC method can be applied to estimate lipoprotein profile of T2DM patients. Particularly, IDL cholesterol may be useful for the evaluation of impaired lipid metabolism in T2DM patients without dialysis therapy, but it remains to be cleared.