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用于测定血浆中总同型半胱氨酸的酶免疫测定法的验证

Validation of an enzyme immunoassay for the determination of total homocysteine in plasma.

作者信息

Quintana I, Freeman D, Galarza C, Murua A, Spence J D, Kordich L

机构信息

Department of Biological Chemistry, School of Exact and Natural Sciences, Buenos Aires University, Argentina.

出版信息

Blood Coagul Fibrinolysis. 2000 Apr;11(3):235-8.

PMID:10870802
Abstract

In recent years, the determination of homocysteine (Hcy) has become increasingly important, since high levels of Hcy in plasma or serum represent an independent risk factor for occlusive vascular diseases. Nowadays, clinical laboratories use several analytical techniques to measure Hcy, of which high-performance liquid chromatography (HPLC) is the most popular. Recently, assays for Hcy quantification based on enzyme immunoassays (EIA) have become commercially available. Our group carried out the validation of the Axis method and compared results with those obtained by an established HPLC assay. Intra- and inter-assay coefficients of variation were < or = 8.5%. Compared with HPLC, linear regression analysis showed r=0.984, slope=0.952, intercept = 1.24 /mol/l; Bland-Altman procedure, the mean of the difference EIA-HPLC results = 0.5 micromol/l. Our results suggest that Hcy determinations by both methods are equivalent, and that the Axis assay provides reproducible and reliable data.

摘要

近年来,同型半胱氨酸(Hcy)的测定变得越来越重要,因为血浆或血清中高水平的Hcy是闭塞性血管疾病的一个独立危险因素。如今,临床实验室使用多种分析技术来测量Hcy,其中高效液相色谱法(HPLC)最为常用。最近,基于酶免疫分析(EIA)的Hcy定量检测方法已商业化。我们小组对Axis方法进行了验证,并将结果与通过既定的HPLC检测方法获得的结果进行了比较。批内和批间变异系数≤8.5%。与HPLC相比,线性回归分析显示r = 0.984,斜率 = 0.952,截距 = 1.24 μmol/L;Bland-Altman方法显示,EIA - HPLC结果差异的平均值 = 0.5 μmol/L。我们的结果表明,两种方法测定Hcy的结果相当,并且Axis检测方法能提供可重复且可靠的数据。

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