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
Journal of Atherosclerosis and Thrombosis, vol. 32, pp. 580–595
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: , 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.
Authors 13
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Affiliation as printed
Department of Clinical Laboratory Medicine, Juntendo University Graduate School of Medicine
Department of Clinical Laboratory Technology, Faculty of Medical Science, Juntendo University
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Tokyo Gakugei University · Juntendo University
Affiliation as printed
Department of Clinical Laboratory Medicine, Juntendo University Graduate School of Medicine
Health Care Center, Tokyo Gakugei University
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Affiliation as printed
Department of Clinical Laboratory Medicine, Juntendo University Graduate School of Medicine
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Affiliation as printed
Department of Clinical Laboratory Technology, Faculty of Medical Science, Juntendo University
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Affiliation as printed
Clinical Laboratory, Juntendo University Hospital
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Affiliation as printed
Clinical Laboratory, Juntendo University Hospital
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Affiliation as printed
Clinical Laboratory, Juntendo University Hospital
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Affiliation as printed
Juntendo Advanced Research Institute for Health Science
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Affiliation as printed
Department of Sports Medicine and Sportology, Juntendo University Graduate School of Medicine
Sportology Center, Juntendo University Graduate School of Medicine
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Affiliation as printed
Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine
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Affiliation as printed
Sportology Center, Juntendo University Graduate School of Medicine
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Centers for Disease Control and Prevention · Centers for Disease Control and Prevention · Centers for Disease Control and Prevention
Affiliation as printed
Protein Biomarker and Lipid Reference Laboratory, Clinical Chemistry Branch, Division of Laboratory Sciences, Centers for Disease Control and Prevention
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Leiden University Medical Center
Affiliation as printed
Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center
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