Tate J R, Rifai N, Berg K, Couderc R, Dati F, Kostner G M, Sakurabayashi I, Steinmetz A
Department of Chemical Pathology, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.
Clin Chem. 1998 Aug;44(8 Pt 1):1629-40.
A secondary reference material for lipoprotein(a) is required to standardize the measurement of lipoprotein(a) in clinical laboratories worldwide. Towards this aim, the International Federation of Clinical Chemistry Working Group for the Standardization of Lipoprotein(a) Assays has initiated a standardization project involving a total of 33 diagnostic company and clinical chemistry laboratories from 12 countries. In Phase 1, the analytical performance of 40 lipoprotein(a) assay systems was evaluated by testing sera and manufactured lipoprotein(a) calibrator materials for precision, linearity, and parallelism. Twenty test systems were nonoptimized according to the results for a pooled serum, which tested nonlinear in 16 systems and imprecise in 4. Acceptable analytical properties and harmonization of lipoprotein(a) values were shown by some commercial calibrators, suggesting their possible use as reference materials. This study highlights the problems that currently occur for lipoprotein(a) measurement in existing assay systems.
全球临床实验室需要一种脂蛋白(a)的二级参考物质，以规范脂蛋白(a)的测量。为实现这一目标，国际临床化学联合会脂蛋白(a)检测标准化工作组启动了一个标准化项目，共有来自12个国家的33家诊断公司和临床化学实验室参与。在第一阶段，通过检测血清和人工合成的脂蛋白(a)校准物质，评估了40种脂蛋白(a)检测系统的分析性能，包括精密度、线性和并行性。根据混合血清的检测结果，20个检测系统未达到最佳状态，其中16个系统检测呈非线性，4个系统检测不精确。一些商业校准物显示出可接受的分析特性和脂蛋白(a)值的一致性，表明它们有可能用作参考物质。本研究突出了现有检测系统中目前脂蛋白(a)测量存在的问题。
