Health Diagnostic Laboratory, Inc., 737 N. 5th Street, Richmond, VA 23219, United States.
Clin Chim Acta. 2013 Oct 21;425:37-41. doi: 10.1016/j.cca.2013.07.007. Epub 2013 Jul 24.
Low serum concentration of high density lipoprotein2 cholesterol (HDL2-C) is associated with increased risk of cardiovascular events. HDL2-C is calculated indirectly by subtracting high density lipoprotein3 cholesterol (HDL3-C) from total high density lipoprotein cholesterol (HDL-C). However, the special equipment and long assay times required for HDL3-C measurement have hindered the use of HDL2-C clinically. Here, we report the validation of a simple and rapid homogeneous assay for HDL3-C that is adaptable to clinical chemistry analyzers.
Method comparison based on 2740 serum specimens spanning the physiological range of HDL3-C was analyzed in singlicate to evaluate and validate a new homogeneous assay from Denka Seiken against the conventional dextran sulfate precipitation method. This study was performed over five days. Serum pools were prepared for the analysis of precision over 5 days (5 measurements per day), linearity, and interference (hemoglobin, bilirubin, and triglycerides) evaluation.
The homogeneous method had good within-run precision at concentrations of 24, 36, and 46 mg/dl, yielding standard deviations (SD) of 0.2 (0.9%) 0.4 (1.2%), and 0.5 (1.1%), respectively. Between-day precision, performed over 5 days using the same serum pools, yielded SD of 0.3 (1.4%), 1.0 (2.8%), and 0.9 (2.0%), respectively. The assay was linear from 1 to 100 mg/dl and correlated very well with the dextran sulfate precipitation method. There was no interference from hemoglobin up to 500 mg/dl, bilirubin up to 25 mg/dl, or triglycerides up to 1500 mg/dl.
This homogeneous HDL3-C assay quantitatively measures HDL3-C in serum samples and has excellent precision, and can be implemented on an automated chemistry analyzer, thereby facilitating rapid measurement (~10 min) of a large number of samples in a standard clinical laboratory without the need for additional expensive equipment, laboratory space, or specially-trained staff.
血清高密度脂蛋白 2 胆固醇（HDL2-C）浓度低与心血管事件风险增加有关。HDL2-C 通过从总高密度脂蛋白胆固醇（HDL-C）中减去高密度脂蛋白 3 胆固醇（HDL3-C）间接计算。然而，HDL3-C 测量所需的特殊设备和较长的检测时间阻碍了其在临床上的应用。在这里，我们报告了一种简单快速的均相测定法用于 HDL3-C 的验证，该方法适用于临床化学分析仪。
基于涵盖 HDL3-C 生理范围的 2740 份血清标本的方法比较，在单日内分析，以评估和验证新的均相测定法（来自 Denka Seiken）与传统的葡聚糖硫酸盐沉淀法相比。本研究共进行了五天。为了分析五天内的精密度（每天测量 5 次）、线性度和干扰（血红蛋白、胆红素和甘油三酯），制备了血清池。
均相法在 24、36 和 46mg/dl 浓度下具有良好的批内精密度，标准偏差（SD）分别为 0.2（0.9%）、0.4（1.2%）和 0.5（1.1%）。使用相同的血清池在五天内进行批间精密度，SD 分别为 0.3（1.4%）、1.0（2.8%）和 0.9（2.0%）。该测定法在 1 至 100mg/dl 范围内呈线性，与葡聚糖硫酸盐沉淀法相关性非常好。血红蛋白高达 500mg/dl、胆红素高达 25mg/dl 或甘油三酯高达 1500mg/dl 时无干扰。
这种均相 HDL3-C 测定法定量测定血清样本中的 HDL3-C，具有优异的精密度，可在自动化化学分析仪上实施，从而无需额外昂贵的设备、实验室空间或专门的人员，即可快速测量（~10 分钟）大量样品，在标准临床实验室中。
