Real-world impact of transitioning from one lipoprotein(a) assay to another in a clinical setting

Janeni Jeevanathan¹, Sigrid M Blom², Thomas Olsen¹, Kirsten B Holven^{1

3}, Erik K Arnesen¹, Torleif Trydal⁴, Børge G Nordestgaard^{5

6}, Michael Sovershaev⁷, Ying Chen^{7

8}, Kjetil Retterstøl^{1

9}, Jacob J Christensen¹

Affiliations

¹ Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, P.O. Box 1046 Blindern, 0317, Oslo, Norway.
² Novartis Norway AS, Nydalen alle 37, 0484, Oslo, Norway.
³ Norwegian National Advisory Unit on Familial Hypercholesterolemia, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital Aker, P.O. Box 4959 Nydalen, 0424, Oslo, Norway.
⁴ Department of Clinical Research, Sørlandet Hospital, SSHF, P.O. Box 416 Lundsiden, 4604, Kristiansand, Norway.
⁵ The Department of Clinical Biochemistry, Herlev and Gentofte Hospital, Copenhagen University Hospital, Borgmester Ib Juuls Vej 73, opgang 7, 2730, Herlev, Denmark.
⁶ Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.
⁷ Fürst Medical Laboratory, P. O. Box 158 Alnabru, 0614, Oslo, Norway.
⁸ Oslo Metropolitan University, P. O. Box 4, Norway.
⁹ The Lipid Clinic, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital Aker, P. O. Box 4959 Nydalen, 0424, Oslo, Norway.

PMID: 39286651
PMCID: PMC11402909
DOI: 10.1016/j.ajpc.2024.100726

Real-world impact of transitioning from one lipoprotein(a) assay to another in a clinical setting

Janeni Jeevanathan et al. Am J Prev Cardiol. 2024.

. 2024 Aug 25:19:100726.

doi: 10.1016/j.ajpc.2024.100726. eCollection 2024 Sep.

Authors

Affiliations

¹ Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, P.O. Box 1046 Blindern, 0317, Oslo, Norway.
² Novartis Norway AS, Nydalen alle 37, 0484, Oslo, Norway.
³ Norwegian National Advisory Unit on Familial Hypercholesterolemia, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital Aker, P.O. Box 4959 Nydalen, 0424, Oslo, Norway.
⁴ Department of Clinical Research, Sørlandet Hospital, SSHF, P.O. Box 416 Lundsiden, 4604, Kristiansand, Norway.
⁵ The Department of Clinical Biochemistry, Herlev and Gentofte Hospital, Copenhagen University Hospital, Borgmester Ib Juuls Vej 73, opgang 7, 2730, Herlev, Denmark.
⁶ Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.
⁷ Fürst Medical Laboratory, P. O. Box 158 Alnabru, 0614, Oslo, Norway.
⁸ Oslo Metropolitan University, P. O. Box 4, Norway.
⁹ The Lipid Clinic, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital Aker, P. O. Box 4959 Nydalen, 0424, Oslo, Norway.

PMID: 39286651
PMCID: PMC11402909
DOI: 10.1016/j.ajpc.2024.100726

Abstract

Background and aims: Different lipoprotein(a) [Lp(a)] assays may affect risk stratification of individuals and thus clinical decision-making. We aimed to investigate how transitioning between Lp(a) assays at a large central laboratory affected the proportion of individuals with Lp(a) result above clinical thresholds.

Methods: We studied nationwide clinical laboratory data including 185,493 unique individuals (47.7 % women) aged 18-50 years with 272,463 Lp(a) measurements using Roche (2000-2009) and Siemens Lp(a) assay (2009-2019).

Results: While the majority of individuals (66-75 %) had low levels of Lp(a) (<30 mg/dL) independent of the assay used, the Roche assay detected 20 % more individuals with Lp(a) >50 mg/dL, 40 % more individuals with Lp(a) >100 mg/dL and 80 % more individuals with Lp(a) > 180 mg/dL than the currently used Siemens assay, likely due to calibration differences.

Conclusion: Transitioning from one Lp(a) immunoassay to another had significant impact on Lp(a) results, particularly in individuals approaching clinically relevant Lp(a) thresholds.

Keywords: Lipids; Lipoprotein(a); Lipoprotein(a) assay.

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Conflict of interest statement

Jeevanathan has received consultancy fees from Novartis, and had a part time student internship at Novartis organized by the Faculty of Medicine at University of Oslo and the Student Association for Medical Innovation prior to this study. Dr. Blom is an employee of Novartis Norway AS. Dr. Nordestgaard has had consultancies or talks sponsored by Abbott, Akcea, Amarin, Amgen, AstraZeneca, Denka, Esperion, Kowa, Lilly, Mankind, Novartis, Novo Nordisk, Regeneron, Sanofi, Silence Therapeutics, Ultragenyx, and USV. Dr. Retterstøl has received personal fees from Amgen, Mills AS, The Norwegian Medical Association, The Norwegian Directorate of Health, Sanofi, Novo Nordisk, none of which are related to the content of this manuscript. The other authors have no financial relationships relevant to disclose.

Figures

Image, graphical abstract — **Graphical abstract**

Fig 1: — **Fig. 1**
Percentiles of Lp(a) levels in serum samples between 2000 – 2019. Date of Lp(a) measurement was cut into breaks of 30 days. Rolling average of 10^th, 20^th, 30^th, 40^th, 50^th (median), 60^th, 70^th, 80^th and 90^th percentile of Lp(a) on log scale in each break was calculated. X-axis is date on continuous scale but breaks per year is shown here. Lp(a) values are on log scale, and the Y-axis has been back-transformed. Red arrows indicate the most important changes in the methods of analyzing Lp(a). Measuring interval in 2000-2009 was 6.0-354 mg/d, analyzed by the Roche Tina-quant assay. Measuring interval in 2009-2016, 2016-2018 and 2018-2019, analyzed by the Siemens Lipoprotein(a) assay, was 2.5-90 mg/dL, 10-85 mg/dL and 10-340 mg/dL, respectively. Lp(a) = lipoprotein(a).

Fig 2: — **Fig. 2**
Distribution of Lp(a) in this Norwegian study cohort using common thresholds, where 50 mg/dL was determined as the 80^th percentile in Caucasians (1). The graph is based on serum samples from 74,989 individuals between 2000-September 2009 and 123,435 individuals between September 2009-2019 from Fürst Medical Laboratory. Lp(a) = lipoprotein(a).

See this image and copyright information in PMC

References

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Real-world impact of transitioning from one lipoprotein(a) assay to another in a clinical setting

Affiliations

Real-world impact of transitioning from one lipoprotein(a) assay to another in a clinical setting

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

LinkOut - more resources

Full Text Sources

Miscellaneous