Cobbaert C, Zwang L, Ceriotti F, Modenese A, Cremer P, Herrmann W, Hoss G, Jarausch J, Türk R, März W, Nauck M
Academic Hospital Rotterdam, The Netherlands.
Clin Chem. 1998 Apr;44(4):779-89.
A homogeneous HDL-c assay (HDL-H), which uses polyethylene glycol-modified enzymes and sulfated alpha-cyclodextrin, was assessed for precision, accuracy, and cholesterol and triglyceride interference. In addition, its analytical performance was compared with that of a phosphotungstic acid (PTA)/MgCl2 precipitation method (HDL-P). Within-run CVs were < or = 1.87%; total CVs were < or = 3.08%. Accuracy was evaluated in fresh normotriglyceridemic sera using the Designated Comparison Method (HDL-H = 1.037 Designated Comparison Method + 4 mg/L; n = 63) and in moderately hypertriglyceridemic sera by using the Reference Method (HDL-H = 1.068 Reference Method - 17 mg/L; n = 41). Mean biases were 4.5% and 2.2%, respectively. In hypertriglyceridemic sera (n = 85), HDL-H concentrations were increasingly positively biased with increasing triglyceride concentrations. The method comparison between HDL-H and HDL-P yielded the following equation: HDL-H = 1.037 HDL-P + 15 mg/L; n = 478. We conclude that HDL-H amply meets the 1998 NCEP recommendations for total error; its precision is superior compared with that of HDL-P, and its average bias remains below +/-5% as long as triglyceride concentrations are < or = 10 g/L and in case of moderate hypercholesterolemia.
一种使用聚乙二醇修饰酶和硫酸化α-环糊精的均相高密度脂蛋白胆固醇（HDL-c）检测方法（HDL-H），对其精密度、准确性以及胆固醇和甘油三酯干扰情况进行了评估。此外，还将其分析性能与磷钨酸（PTA）/氯化镁沉淀法（HDL-P）进行了比较。批内变异系数（CV）≤1.87%；总变异系数≤3.08%。采用指定比较法在新鲜正常甘油三酯血症血清中评估准确性（HDL-H = 1.037指定比较法 + 4 mg/L；n = 63），并在中度高甘油三酯血症血清中采用参考方法评估（HDL-H = 1.068参考方法 - 17 mg/L；n = 41）。平均偏差分别为4.5%和2.2%。在高甘油三酯血症血清（n = 85）中，HDL-H浓度随甘油三酯浓度升高而出现越来越大的正偏差。HDL-H与HDL-P之间的方法比较得出以下方程：HDL-H = 1.037 HDL-P + 15 mg/L；n = 478。我们得出结论，HDL-H完全符合1998年美国国家胆固醇教育计划（NCEP）对总误差的建议；其精密度优于HDL-P，并且只要甘油三酯浓度≤10 g/L以及在中度高胆固醇血症情况下，其平均偏差仍保持在±5%以下。
