Cited by 386Clinical Laboratory Practices and Quality ControlLipoproteins and Cardiovascular HealthScientific Measurement and Uncertainty Evaluation

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Seven Direct Methods for Measuring HDL and LDL Cholesterol Compared with Ultracentrifugation Reference Measurement Procedures

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Abstract

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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Crossref · 10.1373/clinchem.2009.142810

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Research works printed but not linked: 4

  1. 2009, Clin Chem, 55, 88
  2. 1999, Preparation and validation of commutable frozen human serum pools as secondary reference materials for cholesterol measurement procedures; approved guideline. CLSI document C37-A
  3. 1990, Scand J Clin Lab Invest Suppl, 198, 9
  4. 1999, Am J Cardiol, 83, 3F

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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
Venue
Clinical Chemistry
Published
2010-06-01
Volume
56
Issue
6
Pages
977-986
ISSN
  • 0009-9147 (ISSN-L)
  • 1530-8561
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
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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