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Vitamin B12 quality control trials

D W Dawson, D I Fish, I D Frew

    Clinical and Laboratory Haematology
    |January 1, 1981
    PubMed
    Summary
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    Regional quality control trials for vitamin B12 assays revealed issues with method linearity and kit precision. Improved performance identification was achieved using a target coefficient of variation and reference serum.

    Area of Science:

    • Clinical Chemistry
    • Laboratory Medicine
    • Analytical Toxicology

    Background:

    • Vitamin B12 assays are crucial for diagnosing deficiencies and monitoring treatment.
    • External quality assessment schemes are vital for ensuring assay reliability and comparability.
    • Previous quality control initiatives highlighted variability in vitamin B12 measurement.

    Purpose of the Study:

    • To evaluate the performance of laboratories conducting vitamin B12 assays.
    • To assess the suitability of materials for quality control trials.
    • To identify areas for improvement in vitamin B12 assay methodology and quality control.

    Main Methods:

    • Analysis of results from regional quality control trials.
    • Assessment of technical and clinical performance of participating laboratories.

    Related Experiment Videos

  • Evaluation of different vitamin B12 assay methods and commercially available kits.
  • Utilisation of a reference serum for inter-method comparison.
  • Implementation of a target coefficient of variation for performance assessment.

    • Main Results:

    • The introduction of a target coefficient of variation improved the identification of laboratory performance.
    • A reference serum enabled effective comparison between assays employing different methods.
    • Most methods exhibited questionable linearity, necessitating reference sera with diverse concentrations.
    • The adoption of assay kits did not consistently enhance precision.
    • Significant inter-laboratory variation indicated potential for improved kit utilization.

    Conclusions:

    • Quality control trials are essential for identifying and addressing performance issues in vitamin B12 assays.
    • Standardized reference materials and performance metrics are crucial for reliable assay comparison.
    • Further optimization of assay methods, particularly regarding linearity, and kit usage is required.
    • Continuous monitoring and improvement of laboratory practices are necessary to ensure accurate vitamin B12 measurements.