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Apolipoprotein assays: standardization and quality control.

S M Marcovina1, J J Albers

  • 1Department of Medicine, University of Washington School of Medicine, Seattle 98104-2499.

Scandinavian Journal of Clinical and Laboratory Investigation. Supplementum
|January 1, 1990
PubMed
Summary

Standardizing apolipoprotein A-I (apo A-I) and apolipoprotein B (apo B) requires accurate methods and quality assurance. This ensures reliable international reference intervals by minimizing preanalytical and analytical variations.

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Area of Science:

  • Clinical Chemistry
  • Biomarker Standardization
  • Laboratory Medicine

Background:

  • Variability in apolipoprotein A-I (apo A-I) and apolipoprotein B (apo B) measurements impacts clinical utility.
  • Preanalytical and analytical variations contribute significantly to assay result discrepancies.
  • Standardized international reference intervals are crucial for accurate diagnosis and monitoring.

Purpose of the Study:

  • To outline a framework for the standardization of apo A-I and apo B measurements.
  • To emphasize the importance of accuracy-based methods and quality assurance programs.
  • To detail a calibration system traceable to a primary standard for reliable results.

Main Methods:

  • Establishing a primary standard with accurately determined absolute mass.

Related Experiment Videos

  • Utilizing a reference method to assign target values to reference materials.
  • Employing reference materials that mimic patient samples immunochemically across methods.
  • Developing and distributing reference and quality control materials free from matrix effects.

    • Main Results:

    • A traceable calibration system ensures all assay results link back to the primary standard.
    • Standardized protocols reduce inter-method variation in apo A-I and apo B determinations.
    • Minimizing preanalytical and analytical errors is key to defining accurate reference intervals.
    • Consistent reference materials are fundamental for successful laboratory standardization.

    Conclusions:

    • A robust standardization approach, including primary standards and traceable reference materials, is essential for accurate apo A-I and apo B reference intervals.
    • Minimizing variability through standardized methods and quality control is critical for reliable clinical chemistry.
    • This framework supports the development of globally accepted reference intervals for apolipoproteins.