Harmonization of Lipoprotein(a) Immunoassays Using A Serum Panel Value Assigned with The IFCC-Endorsed Mass Spectrometry-Based Reference Measurement Procedure as A First Step Towards Apolipoprotein Standardization.

IF 3 2区 医学 Q2 PERIPHERAL VASCULAR DISEASE
Takashi Miida, Satoshi Hirayama, Yoshifumi Fukushima, Atsushi Hori, Satomi Ito, Masanobu Hinata, Mitsuru Wakita, Hiroki Tabata, Yoshifumi Tamura, Hirotaka Watada, Ryuzo Kawamori, Hubert W Vesper, Christa M Cobbaert
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Abstract

Aim: Lipoprotein (a) [Lp(a)] is a well-established risk factor for cardiovascular disease independent of low-density lipoprotein-cholesterol (LDL-C). The Lp(a) concentrations were inconsistent between the immunoassays. This study aimed to investigate whether harmonization of Lp(a) measurements can be achieved using a serum panel value assigned with the IFCC-endorsed mass spectrometry-based reference measurement procedure (IFCC-MS-RMP).

Methods: We measured the Lp(a) concentrations using five Lp(a) immunoassays in 40 panel sera provided by the Centers for Disease Control and Prevention (CDC), and 500 Japanese subjects enrolled in the Bunkyo Health Study. Of the five immunoassays, only the Roche Lp(a) assay was traceable to the WHO-IFCC reference material SRM2B. Lp(a) concentrations in CDC samples were also determined by IFCC-MS-RMP, provisionally calibrated to SRM2B. Lp(a) concentrations were expressed in mass units (mg/dL) for most reagents, but in SI units (nmol/L) for Roche's reagent and IFCC-MS-RMP.

Results: In the CDC panel sera, all immunoassays, including Roche's reagent, showed good correlations with IFCC-MS-RMP. In the Bunkyo Health Study samples, all immunoassays showed good correlations with Roche's reagent (rs, 0.986-0.998) although the slopes of the regression lines ranged from 0.292 to 0.579. After recalibration with the CDC's panel sera, Lp(a) results of Bunkyo Health Study samples were converted to the equivalent values determined by the IFCC-MS-RMP, thus resulting in a marked reduction in the intermethod CV among the assays.

Conclusion: We achieved harmonization of Lp(a) measurements with five immunoassays using a serum panel value assigned with the IFCC-MS-RMP.

统一脂蛋白(a)免疫测定,使用 IFCC 认可的基于质谱的参考测量程序分配的血清面板值,作为实现载脂蛋白标准化的第一步。
目的:脂蛋白(a)[Lp(a)]是一种独立于低密度脂蛋白胆固醇(LDL-C)的公认的心血管疾病风险因素。不同免疫测定方法的脂蛋白(a)浓度不一致。本研究旨在探讨是否可以使用 IFCC 认可的基于质谱的参考测量程序(IFCC-MS-RMP)分配的血清面板值来统一脂蛋白(a)的测量:我们使用五种脂蛋白(a)免疫测定方法测量了由美国疾病控制与预防中心(CDC)提供的 40 份血清样本和参加文京健康研究的 500 名日本受试者的脂蛋白(a)浓度。在这五种免疫测定方法中,只有罗氏公司的脂蛋白(a)测定可追溯到世界卫生组织-国际癌症研究中心参考材料 SRM2B。疾病预防控制中心样本中的脂蛋白(a)浓度也是通过 IFCC-MS-RMP 测定的,暂时校准为 SRM2B。大多数试剂的脂蛋白(a)浓度以质量单位(毫克/分升)表示,而罗氏试剂和 IFCC-MS-RMP 的脂蛋白(a)浓度则以 SI 单位(毫摩尔/升)表示:在疾病预防控制中心小组血清中,包括罗氏试剂在内的所有免疫测定与 IFCC-MS-RMP 都显示出良好的相关性。在文京健康研究样本中,尽管回归线的斜率从 0.292 到 0.579 不等,但所有免疫测定与罗氏试剂都显示出良好的相关性(rs,0.986-0.998)。在用中国疾病预防控制中心的小组血清重新校准后,文京健康研究样本的脂蛋白(a)结果被转换成了 IFCC-MS-RMP 确定的等效值,从而显著降低了检测方法间的变异系数:我们使用 IFCC-MS-RMP 指定的血清面板值实现了五种免疫测定法对脂蛋白(a)测量结果的统一。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
6.60
自引率
15.90%
发文量
271
审稿时长
1 months
期刊介绍: JAT publishes articles focused on all aspects of research on atherosclerosis, vascular biology, thrombosis, lipid and metabolism.
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