Ueda Yasuki, Matsui Masahiko, Hayashi Sadao, Yamaguchi Yoshihisa, Kanakura Yuzuru
Laboratory for Clinical Investigation, Osaka University Hospital, Osaka, Japan.
J Clin Lab Anal. 2003;17(6):201-8. doi: 10.1002/jcla.10101.
Homogeneous HDL-cholesterol assays have been developed and used widely in routine analysis, but they have been reported to give inaccurate results in patients with hypertriglyceridemia. Recently, a new assay based on a new principle without the influence of triglycerides has also been developed and commercialized. We evaluated the basic performance of this new homogeneous HDL-cholesterol assay and compared it with the conventional polyethylene glycol/cyclodextrin-modified enzyme (PEGME) method using high-triglyceride (TG) samples (TG>8000 mg/L). For samples showing a discrepancy with the conventional method, other precipitation and ultracentrifugation (UC) methods were also used to confirm the values. This new homogeneous assay is based on the selective solubilizing effect of detergent on the different lipoproteins. First, non-HDL free cholesterol is consumed by enzyme and is cleared as a colorless reactant. Then. HDL-cholesterol is selectively solubilized by lipoprotein-specific detergent and reacted with the enzyme. As a result, the precision of this new homogeneous assay was good (CV<2%) over the wide range, and the measurement range was 0 to 2000 mg/L. This method correlated well with the PEGME method, which is a conventional method for normolipidemic samples (y=0.97x-3.1, r=0.994, n=424). It also correlated well with the UC method (y=0.99x+0.3, r=0.989, n=53). Fourteen high-TG samples showed different results from those obtained by the PEGME method. Among these samples, one contained abnormal lipoproteins (probably due to the influence of drug therapy) and gave a significantly different result from that obtained by the PEGME method. However, the values obtained by other methods (precipitation and ultracentrifugation) agreed well with those obtained by this new method. In conclusion, this method shows a good basic performance and is useful for high-TG samples without any interference. Therefore, it is considered to be very practical for a routine test.
均相高密度脂蛋白胆固醇检测方法已被开发并广泛应用于常规分析，但据报道，它们在高甘油三酯血症患者中会给出不准确的结果。最近，一种基于新原理且不受甘油三酯影响的新检测方法也已被开发并商业化。我们评估了这种新的均相高密度脂蛋白胆固醇检测方法的基本性能，并使用高甘油三酯（TG）样本（TG>8000mg/L）将其与传统的聚乙二醇/环糊精修饰酶（PEGME）方法进行比较。对于与传统方法结果不一致的样本，还使用了其他沉淀和超速离心（UC）方法来确认数值。这种新的均相检测方法基于去污剂对不同脂蛋白的选择性增溶作用。首先，非高密度脂蛋白游离胆固醇被酶消耗，并作为无色反应物被清除。然后，高密度脂蛋白胆固醇被脂蛋白特异性去污剂选择性增溶，并与酶发生反应。结果，这种新的均相检测方法在很宽的范围内精密度良好（CV<2%），测量范围为0至2000mg/L。该方法与PEGME方法（一种用于血脂正常样本的传统方法）相关性良好（y = 0.97x - 3.1，r = 0.994，n = 424）。它与UC方法也相关性良好（y = 0.99x + 0.3，r = 0.989，n = 53）。14个高TG样本的结果与PEGME方法得到的结果不同。在这些样本中，一个含有异常脂蛋白（可能是由于药物治疗的影响），其结果与PEGME方法得到的结果有显著差异。然而，其他方法（沉淀和超速离心）得到的值与这种新方法得到的值非常一致。总之，这种方法显示出良好的基本性能，对于高TG样本没有任何干扰，非常有用。因此，它被认为对于常规检测非常实用。
