Seven direct methods for measuring HDL and LDL cholesterol compared with ultracentrifugation reference measurement procedures
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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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Most discordances in dyslipidemic samples are observed at lower concentration ranges of LDLC (<1.8 mmol/L) and HDLC (<1.0 mmol/L).
“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]
The Results (Trueness and Total Error) say that nearly all discordant results occurred in the diseased group and that, for most methods, they occurred mostly below HDL-C 1.0 mmol/L and LDL-C 2.5 mmol/L. The claimed LDL-C cutoff of 1.8 mmol/L is not the reported discordance range; the Discussion mentions 1.8 mmol/L as a treatment target instead. The Results also note an exception for the UMA methods. (LLM, conf=0.91)
Experimental — accuracy not yet measuredDirect measurements of dLDLC and dHDLC in normolipidemic samples usually meet the 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.
“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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Experimental — accuracy not yet measuredDirect LDL-C measurements have limitations, including systematic bias and inaccuracy in patients with dyslipidaemia, especially at high triglyceride levels.
“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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Self-citationStatin use and all-cause and cancer mortality: BioBank Japan cohort
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Self-citationProgress in the care of common inherited atherogenic disorders of apolipoprotein B metabolism
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- 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 › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › 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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