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Seven Direct Methods for Measuring HDL and LDL Cholesterol Compared with Ultracentrifugation Reference Measurement Procedures
Open accessAbstract
Background: Methods from 7 manufacturers and 1 distributor for directly measuring HDL cholesterol (C) and LDL-C were evaluated for imprecision, trueness, total error, and specificity in nonfrozen serum samples. Methods: We performed each direct method according to the manufacturer’s instructions, using a Roche/Hitachi 917 analyzer, and compared the results with those obtained with reference measurement procedures for HDL-C and LDL-C. Imprecision was estimated for 35 runs performed with frozen pooled serum specimens and triplicate measurements on each individual sample. Sera from 37 individuals without disease and 138 with disease (primarily dyslipidemic and cardiovascular) were measured by each method. Trueness and total error were evaluated from the difference between the direct methods and reference measurement procedures. Specificity was evaluated from the dispersion in differences observed. Results: Imprecision data based on 4 frozen serum pools showed total CVs <3.7% for HDL-C and <4.4% for LDL-C. Bias for the nondiseased group ranged from −5.4% to 4.8% for HDL-C and from −6.8% to 1.1% for LDL-C, and for the diseased group from −8.6% to 8.8% for HDL-C and from −11.8% to 4.1% for LDL-C. Total error for the nondiseased group ranged from −13.4% to 13.6% for HDL-C and from −13.3% to 13.5% for LDL-C, and for the diseased group from −19.8% to 36.3% for HDL-C and from −26.6% to 31.9% for LDL-C. Conclusions: Six of 8 HDL-C and 5 of 8 LDL-C direct methods met the National Cholesterol Education Program total error goals for nondiseased individuals. All the methods failed to meet these goals for diseased individuals, however, because of lack of specificity toward abnormal lipoproteins.
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“It is important to note that direct LDL-C measurements also have limitations, including systematic bias and inaccuracy in patients with dyslipidaemia, especially for high TG levels [88-90].”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [89]
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“Most discordances in dyslipidemic samples are observed at lower concentration ranges of LDLC (< 1.8 mmol/L) and HDLC (< 1.0 mmol/L) [42].”
From Quantifying atherogenic lipoproteins for lipid-lowering strategies: Consensus-based recommendations from EAS and EFLM (2020) · cites this paper as [42]
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“Direct measurements of dLDLC and dHDLC in normolipidemic samples usually meet the National Cholesterol Education Program (NCEP) total error goals of ≤12% and ≤13%, respectively, but total error ranged from -26% to +32% for dLDLC and -20% to +36% for dHDLC in a comprehensive study of different assays in dyslipidemic samples [42].”
From Quantifying atherogenic lipoproteins for lipid-lowering strategies: Consensus-based recommendations from EAS and EFLM (2020) · cites this paper as [42]
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Metadata
- Authors
- Miller, W. G., Myers, G. L., Sakurabayashi, I., Bachmann, L. M., Caudill, S. P., Dziekonski, A., Edwards, S., Kimberly, M. M., Korzun, W. J., Leary, E. T., Nakajima, K., Nakamura, M., Nilsson, G., Shamburek, R. D., Vetrovec, G. W., Warnick, G. R., & Remaley, A. T.
- Affiliations
- Virginia Commonwealth University (US)
- Centers for Disease Control and Prevention (US)
- Jichi Medical University (JP)
- Virginia Commonwealth University, Richmond, VA
- Pacific Biomarkers (United States) (US)
- Otsuka (Japan) (JP)
- Osaka Medical Center for Health Science and Promotion, Osaka, Japan
- Nilsson Measurement Quality, Uppsala, Sweden
- National Institutes of Health (US)
- Health Diagnostics Laboratory, Richmond, VA
- Corresponding author
- Miller, W Greg
- ORCID
- Venue
- Clinical Chemistry
- Publisher
- Oxford University Press (OUP)
- Published
- 2010-06-01
- Volume
- 56
- Issue
- 6
- Pages
- 977-986
- ISSN
- 0009-9147 (ISSN-L)
- 1530-8561
- PMC
- PMC4687457
- OpenAlex
- W2130132335
- Cited by
- 386
- References
- 23
- Citations by year
- 2026: 22 · 2025: 31 · 2024: 25 · 2023: 31 · 2022: 30 · 2021: 30 · 2020: 31 · 2019: 26 · 2018: 22 · 2017: 21 · 2016: 15 · 2015: 14 · 2014: 27 · 2013: 16 · 2012: 17
- FWCI
- 13.22
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
- Locations
- Clinical Chemistry (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Merck
- Pfizer
- Abbott
- NIH
- Topics
- Health Sciences › Health Professions › Medical Laboratory Technology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
- Physical Sciences › Physics and Astronomy › Instrumentation › Scientific Measurement and Uncertainty Evaluation
- Keywords
- HDL cholesterol, LDL cholesterol, direct measurement method, method comparison, total error, imprecision, trueness, specificity, dyslipidemia, cardiovascular disease
- MeSH terms
- Blood Chemical Analysis, Humans, Cholesterol, HDL, Cholesterol, LDL, Reference Standards, Sensitivity and Specificity, Ultracentrifugation
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