低密度脂蛋白胆固醇保护性试剂匀相测定法的临床评价

目的 对低密度脂蛋白胆固醇(LDT-C)保护性试剂匀相测定法进行临床评价。 方法 分析了保护性试剂匀相测定法的精密度、准确性、特异性和干扰因素.并随机选取了219份病人血清标本,比较分析用保护性试剂匀相测定法直接测定与Friedewald公式和Planella公式计算的LDL—C结果。 结果 保护性试剂匀相测定法具有较好的精密度(批内、批间CV和总CV均小于3％)。线性范围至10.4mmol/L,最低检测浓度为0.08mmol/L,平均同收率为101.2％:基本不受极低密度脂蛋白(VLDL)、高密度脂蛋白(HDL)和血红蛋白的影响。在TG<4.52mmol/L时,用匀相测定法与Friedewald公式和Planella公式的计算法结果之间相关性良好,两种公式计算法结果之间的也有较好相关性;而在TG>4.52mmoL/L时,匀相测定法与两种计算法之间的相关性差。结论 保护性试剂匀相测定法简便、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。

Clinical evaluation of protecting reagent homogeneous assay for measuring low-density lipoprotein cholesterol

Objective To evaluate the clinical efficacy of a homogeneous assay for direct determination of low-density lipoprotein cholesterol(LDL-C) based on the principle of enzymatic selective protection method (protecting reagent assay). Method The precision, accuracy , specificity and interference of the homogeneous were analyzed, The results of serum LDL-C measured by homogeneous assay were compared with Friedewald and Planella formula methods. Rusults The homogeneous assay was precise, having a low with-run CV, day to day CV and total CV (<3%). Linear was up to 10.4mmol/L. The lowest detectable concentration was 0.08mmol/L. Recovery was 101.2%. VLDL^ HDL and hemoglobin did not interfere the LDL-C results. When TG<4.52mmol/L, the LDL-C value measured by homogeneous assay were closely correlated with the two formulas, the values calculated by the two formulas were correlated well too. When TG> 4.52mmol/L, the correlations between homogeneous assay method and the two formulas were low. Conclusions The homogeneous assay meets the requirements for accuracy, precision, ease of handling with massive sample, and full automation, and it is clinically useful.