Alicia N Lyle, Elias N Flores, Clark C Coffman, Alex H Doty, Otoe Sugahara, Florian Kronenberg, L Renee Ruhaak, Christa M Cobbaert, Hubert W Vesper
{"title":"Interlaboratory comparison of serum lipoprotein(a) analytical results across clinical assays-Steps toward standardization.","authors":"Alicia N Lyle, Elias N Flores, Clark C Coffman, Alex H Doty, Otoe Sugahara, Florian Kronenberg, L Renee Ruhaak, Christa M Cobbaert, Hubert W Vesper","doi":"10.1016/j.jacl.2025.02.010","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Lipoprotein(a) [Lp(a)] is an independent risk factor for cardiovascular diseases (CVD). Recent clinical guidelines recommend measuring Lp(a); however, the lack of Lp(a) assay standardization presents challenges to using common clinical decision points. Assay standardization may minimize inter-assay variability. This improves consistency in CVD risk assessment and evaluations of Lp(a) therapeutic efficacy. Genetically determined size variations in the defining apolipoprotein(a) [apo(a)] protein contribute to inter-individual Lp(a) heterogeneity. Individuals who express 2 apo(a) isoforms have 2 sizes of apo(a) in circulation, further contributing to Lp(a) heterogeneity.</p><p><strong>Objective: </strong>The Centers for Disease Control and Prevention's Clinical Standardization Programs (CDC CSP) recently launched an Lp(a) standardization program based on the International Federation of Clinical Chemistry endorsed liquid-chromatography mass spectrometry-based reference measurement procedure (RMP). As part of this program, CDC CSP conducted an interlaboratory comparison study to evaluate current Lp(a) inter-assay variability and to investigate potential factors contributing to measurement variability.</p><p><strong>Methods: </strong>Eight clinical laboratories measured Lp(a) in 40 individual donor serum samples and 3 serum pools. Serum samples were immunophenotyped by Western blot analysis to determine Lp(a) isoform sizes. Sample concentrations were measured in duplicate over 2 independent runs.</p><p><strong>Results: </strong>Assay-specific Lp(a) measurements demonstrated good linear correlation with the RMP. Lp(a) inter-assay measurement variations ranged from 3.3% to 69.1% across individual samples; however, Lp(a) inter-assay coefficients of variation did not increase in a concentration-dependent manner and were not correlated with Lp(a) isoform sizes.</p><p><strong>Conclusion: </strong>This study provides new insights into Lp(a) inter-assay variability and assay performance in clinical laboratories that will guide future standardization efforts.</p>","PeriodicalId":15392,"journal":{"name":"Journal of clinical lipidology","volume":" ","pages":""},"PeriodicalIF":3.6000,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of clinical lipidology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jacl.2025.02.010","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Lipoprotein(a) [Lp(a)] is an independent risk factor for cardiovascular diseases (CVD). Recent clinical guidelines recommend measuring Lp(a); however, the lack of Lp(a) assay standardization presents challenges to using common clinical decision points. Assay standardization may minimize inter-assay variability. This improves consistency in CVD risk assessment and evaluations of Lp(a) therapeutic efficacy. Genetically determined size variations in the defining apolipoprotein(a) [apo(a)] protein contribute to inter-individual Lp(a) heterogeneity. Individuals who express 2 apo(a) isoforms have 2 sizes of apo(a) in circulation, further contributing to Lp(a) heterogeneity.
Objective: The Centers for Disease Control and Prevention's Clinical Standardization Programs (CDC CSP) recently launched an Lp(a) standardization program based on the International Federation of Clinical Chemistry endorsed liquid-chromatography mass spectrometry-based reference measurement procedure (RMP). As part of this program, CDC CSP conducted an interlaboratory comparison study to evaluate current Lp(a) inter-assay variability and to investigate potential factors contributing to measurement variability.
Methods: Eight clinical laboratories measured Lp(a) in 40 individual donor serum samples and 3 serum pools. Serum samples were immunophenotyped by Western blot analysis to determine Lp(a) isoform sizes. Sample concentrations were measured in duplicate over 2 independent runs.
Results: Assay-specific Lp(a) measurements demonstrated good linear correlation with the RMP. Lp(a) inter-assay measurement variations ranged from 3.3% to 69.1% across individual samples; however, Lp(a) inter-assay coefficients of variation did not increase in a concentration-dependent manner and were not correlated with Lp(a) isoform sizes.
Conclusion: This study provides new insights into Lp(a) inter-assay variability and assay performance in clinical laboratories that will guide future standardization efforts.
期刊介绍：
Because the scope of clinical lipidology is broad, the topics addressed by the Journal are equally diverse. Typical articles explore lipidology as it is practiced in the treatment setting, recent developments in pharmacological research, reports of treatment and trials, case studies, the impact of lifestyle modification, and similar academic material of interest to the practitioner.
Sections of Journal of clinical lipidology will address pioneering studies and the clinicians who conduct them, case studies, ethical standards and conduct, professional guidance such as ATP and NCEP, editorial commentary, letters from readers, National Lipid Association (NLA) news and upcoming event information, as well as abstracts from the NLA annual scientific sessions and the scientific forums held by its chapters, when appropriate.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
