Department of Clinical Laboratory Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan.
National Cerebral and Cardiovascular Center, 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan.
Atherosclerosis. 2014 Mar;233(1):253-9. doi: 10.1016/j.atherosclerosis.2013.12.033. Epub 2014 Jan 8.
High-density lipoprotein-cholesterol (HDL-C) is a negative risk factor for cardiovascular events. Although several homogeneous HDL-C assays are available, their accuracy has not been validated, particularly in subjects with disease. We aimed to clarify whether HDL-C concentrations measured by homogeneous assays [HDL-C (H)] agree with those determined by the reference measurement procedures [HDL-C (RMP)] using ultracentrifugation and precipitation with heparin-manganese reagent in fresh clinical samples.
HDL-C concentrations in samples from 48 healthy subjects and 119 subjects with disease were determined using 12 homogeneous assays and RMPs.
All reagents showed excellent intra- and inter-assay CVs (<2.23%) for two pooled sera. Furthermore, the mean bias was within ± 1.0% in nine reagents using samples from healthy subjects and in eight reagents using samples from subjects with disease. In a single HDL-C (H) determination, the total error requirement of the National Cholesterol Education Program (95% of results < 13%) was fulfilled in nine reagents using samples from healthy subjects and six reagents in those from subjects with disease. Error component analysis revealed that only one reagent exceeded ± 10% total error in samples from healthy subjects, whereas four reagents exceeded this error in samples from subjects with disease. Correlations between HDL-C (H) and HDL-C (RMP) revealed that the slopes were within 1.00 ± 0.06 in six reagents in healthy subjects, and eight reagents in subjects with disease.
Except for three reagents, HDL-C (H) agrees well with HDL-C (RMP) in subjects with common disease, but not in those with extremely low HDL-C or abnormal HDL composition.
高密度脂蛋白胆固醇（HDL-C）是心血管事件的负风险因素。虽然有几种均相 HDL-C 测定法，但它们的准确性尚未得到验证，尤其是在患有疾病的患者中。我们旨在明确使用超速离心和肝素锰试剂沉淀的均相测定法（HDL-C（H））测量的 HDL-C 浓度是否与参考测量程序（HDL-C（RMP））确定的浓度一致，方法是使用新鲜临床样本。
使用 12 种均相测定法和 RMP 测定法，测定了 48 名健康受试者和 119 名患有疾病的受试者的样本中的 HDL-C 浓度。
所有试剂在两种混合血清中均显示出极好的批内和批间 CV（<2.23%）。此外，在使用健康受试者样本的 9 种试剂和使用患有疾病的受试者样本的 8 种试剂中，平均偏差在±1.0%以内。在单次 HDL-C（H）测定中，满足国家胆固醇教育计划（95%的结果<13%）的总误差要求，在使用健康受试者样本的 9 种试剂和使用患有疾病的受试者样本的 6 种试剂中均满足该要求。误差成分分析表明，在健康受试者的样本中，只有一种试剂的总误差超过±10%，而在患有疾病的受试者的样本中，有四种试剂的总误差超过了该值。HDL-C（H）与 HDL-C（RMP）之间的相关性表明，在健康受试者中，有 6 种试剂的斜率在 1.00±0.06 之间，在患有疾病的受试者中，有 8 种试剂的斜率在 1.00±0.06 之间。
除了 3 种试剂外，在患有常见疾病的患者中，HDL-C（H）与 HDL-C（RMP）之间的相关性良好，但在 HDL-C 极低或 HDL 组成异常的患者中则不然。
