Seven direct methods for measuring HDL and LDL cholesterol compared with ultracentrifugation reference measurement procedures.
Seven direct methods for measuring HDL and LDL cholesterol compared with ultracentrifugation reference measurement procedures.
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DOI：
10.1373/clinchem.2009.142810
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发表时间：
2010-06
影响因子：
9.3
通讯作者：
Remaley AT
中科院分区：
文献类型：
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作者：
Miller WG;Myers GL;Sakurabayashi I;Bachmann LM;Caudill SP;Dziekonski A;Edwards S;Kimberly MM;Korzun WJ;Leary ET;Nakajima K;Nakamura M;Nilsson G;Shamburek RD;Vetrovec GW;Warnick GR;Remaley AT
评价了7家生产商和1家经销商直接测定HDL胆固醇（C）和LDL-C的方法在非冷冻血清样本中的不精密度、真实度、总误差和特异性。我们使用Roche/Hitachi 917分析仪，根据制造商的说明进行每种直接方法，并将结果与HDL-C和LDL-C的参考测量程序获得的结果进行比较。估计了使用冷冻合并血清标本进行的35次运行的不精密度，并对各单个样本进行了一式三份测量。用每种方法测量了37名无疾病个体和138名有疾病（主要是血脂异常和心血管疾病）个体的血清。根据直接法和参考测量程序之间的差异，评估了正确性和总误差。根据观察到的差异的离散度评价专属性。基于4个冷冻血清池的不精密度数据显示HDL-C的总CV <3.7%，LDL-C的总CV <4.4%。非患病组的偏倚范围为HDL-C的-5.4%至4.8%，LDL-C的-6.8%至1.1%，患病组的偏倚范围为HDL-C的-8.6%至8.8%，LDL-C的-11.8%至4.1%。未患病组的HDL-C总误差范围为-13.4%至13.6%，LDL-C总误差范围为-13.3%至13.5%，患病组的HDL-C总误差范围为-19.8%至36.3%，LDL-C总误差范围为-26.6%至31.9%。8种HDL-C直接方法中有6种和8种LDL-C直接方法中有5种符合国家胆固醇教育计划对非患病个体的总误差目标。然而，由于缺乏对异常脂蛋白的特异性，所有方法都未能满足患病个体的这些目标。
Methods from 7 manufacturers and 1 distributor for directly measuring HDL cholesterol (C) and LDL-C were evaluated for imprecision, trueness, total error, and specificity in nonfrozen serum samples. We performed each direct method according to the manufacturer’s instructions, using a Roche/Hitachi 917 analyzer, and compared the results with those obtained with reference measurement procedures for HDL-C and LDL-C. Imprecision was estimated for 35 runs performed with frozen pooled serum specimens and triplicate measurements on each individual sample. Sera from 37 individuals without disease and 138 with disease (primarily dyslipidemic and cardiovascular) were measured by each method. Trueness and total error were evaluated from the difference between the direct methods and reference measurement procedures. Specificity was evaluated from the dispersion in differences observed. Imprecision data based on 4 frozen serum pools showed total CVs <3.7% for HDL-C and <4.4% for LDL-C. Bias for the nondiseased group ranged from −5.4% to 4.8% for HDL-C and from −6.8% to 1.1% for LDL-C, and for the diseased group from −8.6% to 8.8% for HDL-C and from −11.8% to 4.1% for LDL-C. Total error for the nondiseased group ranged from −13.4% to 13.6% for HDL-C and from −13.3% to 13.5% for LDL-C, and for the diseased group from −19.8% to 36.3% for HDL-C and from −26.6% to 31.9% for LDL-C. Six of 8 HDL-C and 5 of 8 LDL-C direct methods met the National Cholesterol Education Program total error goals for nondiseased individuals. All the methods failed to meet these goals for diseased individuals, however, because of lack of specificity toward abnormal lipoproteins.