用阴离子交换高效液相色谱法测定的低密度脂蛋白胆固醇水平与β定量参考测量程序的比较验证。

Verification of Low-Density Lipoprotein Cholesterol Levels Measured by Anion-Exchange High-Performance Liquid Chromatography in Comparison with Beta Quantification Reference Measurement Procedure.

机构信息

Bioscience Division, Tosoh Corporation, Kanagawa, Japan.

Department of Laboratory Medicine, The Jikei University Kashiwa Hospital, Chiba, Japan.

出版信息

J Appl Lab Med. 2021 Apr 29;6(3):654-667. doi: 10.1093/jalm/jfaa144.

DOI:10.1093/jalm/jfaa144

PMID:33147343

Abstract

BACKGROUND

A new lipoprotein testing method based on anion-exchange HPLC (AEX-HPLC) was recently established. We verified the accuracy of LDL-C levels, a primary therapeutic target for the prevention of cardiovascular disease (CVD), measured by AEX-HPLC comparing with LDL-C levels measured by beta quantification-reference measurement procedure (BQ-RMP), homogenous assays, and calculation methods.

METHODS

We compared LDL-C levels measured by AEX-HPLC (adLDL-Ch: LDL-Ch and IDL-Ch) and BQ-RMP using blood samples from 52 volunteers. AdLDL-Ch levels were also compared with those measurements by homogeneous assays and calculation methods (Friedewald equation, Martin equation, and Sampson equation) using blood samples from 411 participants with dyslipidemia and/or type 2 diabetes.

RESULTS

The precision and accuracy of adLDL-Ch were verified by BQ-RMP. The mean percentage bias [bias (%)] for LDL-C was 1.2%, and the correlation was y = 0.990x + 3.361 (r = 0.990). These results met the acceptable range of accuracy prescribed by the National Cholesterol Education Program. Additionally, adLDL-Ch levels were correlated with LDL-C levels measured by the 2 homogeneous assays (r > 0.967) and the calculation methods (r > 0.939), in serum samples from patients with hypertriglyceridemia.

CONCLUSIONS

AEX-HPLC is a reliable method for measuring LDL-C levels for CVD risk in daily clinical laboratory analyses.

摘要

背景

最近建立了一种基于阴离子交换高效液相色谱（AEX-HPLC）的新型脂蛋白检测方法。我们通过与 LDL-C 水平测量的β定量参考测量程序（BQ-RMP）、均相测定法和计算方法进行比较，验证了 AEX-HPLC 测量 LDL-C 水平（主要是心血管疾病（CVD）预防的治疗靶点）的准确性。

方法

我们比较了 52 名志愿者的血液样本中 AEX-HPLC（adLDL-Ch：LDL-Ch 和 IDL-Ch）和 BQ-RMP 测量的 LDL-C 水平。使用来自 411 名血脂异常和/或 2 型糖尿病患者的血液样本，还比较了 adLDL-Ch 水平与均相测定法和计算方法（Friedewald 方程、Martin 方程和 Sampson 方程）的测量结果。

结果

BQ-RMP 验证了 adLDL-Ch 的精密度和准确性。LDL-C 的平均偏倚百分比（bias%）为 1.2%，相关性为 y=0.990x+3.361（r=0.990）。这些结果符合国家胆固醇教育计划规定的可接受准确性范围。此外，在高甘油三酯血症患者的血清样本中，adLDL-Ch 水平与 2 种均相测定法（r>0.967）和计算方法（r>0.939）测量的 LDL-C 水平相关。