两种清除法测定低密度脂蛋白胆固醇的临床评价

目的对表面活性剂清除法 (SUR法 )和过氧化氢酶清除法 (CAT法 )两种低密度脂蛋白胆固醇 (LDL C)均相测定法进行临床评价。方法将上述两种方法与聚乙烯硫酸沉淀法 (PVS法 )进行比较 ,分析各自方法的精密度、准确性、特异性和干扰因素。结果两种清除法与PVS法 (X)具有良好的相关性 ,SUR法 (Y1) :Y1=0 .9311X +0 .10 2 2 ,r =0 .980 1;CAT法 (Y2 ) :Y2 =0 .94 0 1X +0 .0 991,r=0 .9832。高、中、低三种LDL C浓度混合血清所测定结果表明两种方法均具有良好的精密度 ,总CV值SUR法 3.4 5 - 3.89% ,CAT法 3.5 1- 3.99% ,均达到临床满意的程度。两法线性范围均较宽 (线性均至 8.2 2mmol/L) ,最低检测浓度均为 0 .12mmol/L ,平均回收率SUR法为 98.0 % ,CAT法为 97.6 %。TG <14 .2mmol/L ,Hb <5g/L ,HDL C <3.88mmol/L ,胆红素 <4 5 0 μmol/L对两法基本无影响。 结论两种LDL C清除法测定结果的准确度和精密度均符合临床要求 ,适宜自动分析 ,值得在临床推广应用。

Clinical Evaluation of Two Kinds of Enzymatic Clearance Assay for Determination of Low-density Lipoprotein Cholesterol

Objective To evaluate the clinical performance of Two kinds of enzymatic clearance assay for determination of low-density lipoprotein cholesterol (LDL-C) based on the principle of synthetic polymer/detergent(SUR) assay and catalase (CAT) method.Methods two kinds enzymatic clearance assay were compared with the precipitation method (PVS method),their precision,accuracy, specificity and interference were analyzed. Results The LDL-C values measured by two kinds enzymatic clearance assays correlated well with those by PVS (X):Y 1=0.9311X+0.1022, r=0.9801 for SUR (Y 1) assay; Y 2=0.9401X+0.0991, r=0.9832 for CAT aasay (Y 2).Both methods had good precise ,the total CV 3.45-3.89% (SUR) and 3.51-3.99% (CAT),respectively. The aasay was lineare up to at least 8.22mmol/L for two kinds enzymatic cleaarance assay, The lowest detectable concentration of the two assays was 0.12mmol/L.The averge recoveries of the two aasays were 98.0% and 97.6%, repectively. Bilirubin < 450 μmol/L,hemoglobin<5g/L,HDL-C<3.88 mmol/L and lipaemic sample with a triglyceride concentration <14.2mmol/L did not interfere with the two kinds enzymatic cleaarance assays. Conclusions: The precision and accuracy of LDL-C determination with two kinds enzymatic cleaarance assays can meet the clinical demand and suitable to full automation.