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The evaluation of imprecision in collaborative immunoassay quality-assessment programmes.

P Compton, B Cole, M Stuart

    Annals of Clinical Biochemistry
    |November 1, 1984
    PubMed
    Summary

    This study introduces a new method for calculating within-laboratory imprecision in quality assessment programs. It better represents laboratory performance by assuming a linear relationship between standard deviation and analyte concentration.

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    Area of Science:

    • Clinical Chemistry
    • Laboratory Medicine
    • Quality Assurance

    Background:

    • Current methods for calculating within-laboratory imprecision in quality assessment (QA) programs often use average standard deviation (SD) or coefficient of variation.
    • These traditional parameters are concentration-independent, which is problematic for immunoassays where imprecision varies with analyte concentration.

    Purpose of the Study:

    • To describe a novel method for calculating within-laboratory imprecision in QA programs.
    • To address the limitations of concentration-independent imprecision parameters in immunoassays.

    Main Methods:

    • Proposed a method assuming a linear relationship between standard deviation (SD) and analyte concentration.
    • Applied this method in QA programs by the Australian Joint Working Party for Quality Control in Immunoassay.

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  • Validated the method's robustness using Monte Carlo simulation.

    • Main Results:

    • The linear relationship method better represents differences in imprecision across analytes, methods, and laboratories compared to single imprecision parameters.
    • This approach allows for precise imprecision calculation at the limits of the reference range.

    Conclusions:

    • The proposed method offers a more accurate representation of within-laboratory imprecision in QA programs for immunoassays.
    • Inappropriate calculation of single imprecision parameters may explain significant differences in laboratory performance across QA programs.