检验医学 ›› 2017, Vol. 32 ›› Issue (7): 555-560.DOI: 10.3969/j.issn.1673-8640.2017.07.001

• 脂蛋白(a)检测方法进展专题 •    下一篇

脂蛋白(a)检测的标准化

冯仁丰   

  1. 上海市临床检验中心,上海 200126
  • 收稿日期:2017-03-24 出版日期:2017-08-08 发布日期:2017-08-09
  • 作者简介:null

    作者简介:冯仁丰,男,1942年生,主任技师。

Standardization for the determination of lipoprotein(a)

FENG Renfeng   

  1. Shanghai Center for Clinical Laboratory,Shanghai 200126,China
  • Received:2017-03-24 Online:2017-08-08 Published:2017-08-09

摘要:

脂蛋白(a)[Lp(a)]是重要的心血管疾病风险预示因子,但各临床实验室间Lp(a)检测结果缺乏可比性限制了其在临床上的广泛应用。尽管在2003年就已建立了Lp(a)的参考方法并确定了参考物质,但直到最近才在市场上出现了真正以nmol/L表达检测结果的商品化试剂,其结果可溯源至世界卫生组织(WHO)/国际临床化学和检验医学联合会(IFCC) SRM 2B。文章简述了Lp(a)检测结果不一致的原因以及Lp(a)的标准化工作,同时介绍了罗氏公司在美国华盛顿大学西北脂类与糖尿病研究实验室(NWLRL)Marcovina教授的指导下,消除了Lp(a)内载脂蛋白(a)[apo(a)]环饼(kringle)结构对检测的影响,使常规检测系统可溯源至WHO/IFCC SRM 2B,从而使Lp(a)检测结果具有可比性。这也是在临床实验室免疫学检测方法设计中很少见的一个示例。

关键词: 脂蛋白(a), 参考物质, 溯源性

Abstract:

Lipoprotein(a)[Lp(a)] is a predictive factor for evaluating the risk of cardiovascular diseases. However,there is no comparability for the results of Lp(a) determinations. So,Lp(a) determination can not be applied widely. Although its reference method and reference materials have been established in 2003,until now,commercial reagents expressing the results as nmol/L just appear. Then,determination results can be traced to World Health Organization (WHO)/ the International Federation of Clinical Chemistry and Laboratory Medicine(IFCC)standard reference material(SRM)2B. This article introduces the causes of result inconsistency,the progress of Lp(a) determination standardization and a valuable example about Roche research. In the guidance of Professor Marcovina from the Northwest Lipid Research Laboratories(NWLRL)at the University of Washington,Roche overcomes the influence of apolipoprotein (apo)(a) kringle structure on the determination of Lp(a),which makes routine determination system being traceable to WHO/IFCC SRM 2B and related results with comparability.

Key words: Lipoprotein(a), Reference materials, Traceability

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