Cited by 342Clinical Laboratory Practices and Quality ControlScientific Measurement and Uncertainty EvaluationLipoproteins and Cardiovascular Health

International Federation of Clinical Chemistry standardization project for measurements of apolipoproteins A-I and B. III. Comparability of apolipoprotein A-I values by use of international reference material

Marcovina, S M, Albers, J J, Henderson, L O, Hannon, W H·1993·Clinical Chemistry

Abstract

In the third phase of the International Federation of Clinical Chemistry (IFCC) study for the standardization of apolipoprotein (apo) measurements, the preparation SP1-01, selected as the candidate international reference material for apo A-I, was investigated for its ability to transfer an accuracy-based value to the immunoassay calibrators and to produce comparability of the values for patients' samples. An apo A-I value of 1.50 g/L (SD 0.08 g/L) was assigned to SP1-01 by a highly standardized RIA calibrated with purified apo A-I for which the mass value had been determined by amino acid analysis. According to a common detailed protocol, the participants transferred the mass value from SP1-01 to the calibrator of each method. To confirm that uniformity of calibration ensures comparability of the values over a wide range of apo A-I values, each laboratory analyzed 50 fresh-frozen samples from individual donors, using an approach similar to that adopted by the Cholesterol Reference Laboratory Network. The consensus mean value for each sample was in excellent agreement with the value assigned by the Northwest Lipid Research Laboratories, with the average absolute bias between assigned and consensus value being 0.01 g/L. The among-laboratory CV on each of the 50 samples ranged from 2.1% to 5.6% (mean 3.6%), demonstrating that comparable apo A-I results can be obtained by a variety of immunochemical methods through the use of certified reference material. Based on the results obtained in these studies, SP1-01 has been approved as Apolipoprotein A-I International Reference Material by the World Health Organization.

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Crossref · 10.1093/clinchem/39.5.773

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Authors
Marcovina, S. M., Albers, J. J., Henderson, L. O., & Hannon, W. H.
Affiliations
University of Washington (US)
Venue
Clinical Chemistry
Published
1993-05-01
Volume
39
Issue
5
Pages
773-781
ISSN
  • 0009-9147 (ISSN-L)
  • 1530-8561
OpenAlex
W1922558941
Cited by
342
References
0
Citations by year
2026: 2 · 2025: 4 · 2023: 4 · 2022: 3 · 2021: 4 · 2020: 6 · 2019: 5 · 2018: 9 · 2017: 9 · 2016: 5 · 2015: 6 · 2014: 17 · 2013: 12 · 2012: 14
FWCI
4.92
Type
journal article
Language
en
Open access
closed
Locations
  • Clinical Chemistry (publishedVersion)
  • PubMed (publishedVersion)
Funders
National Heart, Lung, and Blood Institute (R01HL044105, HL44105)
Topics
  • Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Scientific Measurement and Uncertainty Evaluation
  • Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
Keywords
apolipoprotein A-I, apolipoprotein B, international reference materials, immunoassay calibration, method comparability, interlaboratory agreement, certified reference materials
MeSH terms
Apolipoproteins B, Calibration, Chemistry, Clinical, Drug Stability, Hot Temperature, Humans, Reference Standards, Sensitivity and Specificity, Time Factors, Apolipoprotein A-I

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