两种高密度脂蛋白胆固醇均相测定法的临床评价  

Clinical Evaluation of Two Kinds Homogenous Assays for Determination of High-density Lipoprotein Cholesterol

作　　者：鄢盛恺[1] 任凤琴[1] 宋耀虹[1] 林其燧[1] 

机构地区：[1]中国医学科学院中国协和医科大学协和医院检验科,北京100730

出　　处：《中国医学科学院学报》2002年第3期325-328,共4页Acta Academiae Medicinae Sinicae

摘　　要：目的对选择性抑制法(PPD法)和PEG修饰法(PEGME法)两种高密度脂蛋白胆固醇(HDL-C)均相测定法进行临床评价。方法将上述两种方法与传统的磷钨酸镁沉淀法(PTA-Mg2+法)进行比较,分析各自的精密度、准确性、特异性和干扰因素。结果上述两种均相测定法均具有较好的精密度(批内、日间及总变异系数均小于4%),两均相法与PTA-Mg2+法(X)具有良好相关性犤PPD法(Y):Y=0.9316X+0.1063,相关系数r=0.9762;PEGME法(Y):Y=0.9106X+0.1368,r=0.9894犦。两法线性范围均较宽(线性均至4.14mmol/L),最低检测浓度均为0.08mmol/L,回收率为94.1%～106.2%。两均相法基本不受极低密度脂蛋白、低密度脂蛋白和血红蛋白的影响(偏差均小于5%),甘油三酯浓度在17.0mmol/L以下对两法基本无影响,胆红素高于200mg/L时可使两法测定结果偏低。结论两种HDL-C均相测定法简便、快速、结果准确,易于自动分析,适合在临床实验室常规检测应用。Objective To evaluate the clinical efficacy of two kinds homogenous assays for direct determina-tion of high-density lipoprotein cholesterol (HDL-C)based on the principle of polyanion polymer/detergent (PPD method)and polyethylene glycol-modified enzyme (PEGME)method.Methods The two homogenous methods were compared with the precipitation method (PTA-Mg 2+ method),their precision,accuracy,specificity and interference were also analyzed.Results Both homogenous HDL-C assays were precise,having a within-run CV<3%,day-to-day CV<3%and total CV<4%.The HDL-C values measured by the two homogenous methods correlated well with those by PTA-Mg 2+ method (X):Y=0.9316X+0.1063,r=0.9762for PPD method (Y);and Y=0.9106X+0.1368,r=0.9894for PEGME method (Y).The linearity studies showed the two homogenous methods to be linear up to4.14mmol/L.The lowest detectable concentration of the two methods was apparently0.08mmol/L.Recoveries of the two methods were94.1%～106.2%.Hemoglobin did not interfere with the HDL-C results in the two homogenous methods,whereas icteric samples with total bilirubin>200mg /L showed discrepancies.Lipemia up to triglyceride concentration of17.0mmol/L did not interfere with the two homogenous HDL-C assays.Conclusions The two new homogenous HDL-C assays meet the requirements for accuracy,precision,ease of handling with massive sample,allow full automation,and are clinically useful.

关 键 词：均相测定法 高密度脂蛋白 胆固醇 方法学比较 高脂蛋白血症 选择性抑制法 PEG修饰法 

分 类 号：R446.112[医药卫生—诊断学]