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Related Experiment Videos

External quality control survey for alpha-fetoprotein assay.

G C Zucchelli, A Pilo, M Ferdeghini

    The Journal of Nuclear Medicine and Allied Sciences
    |July 1, 1989
    PubMed
    Summary
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    This study evaluated 11 kits for alpha-fetoprotein (AFP) tumor marker testing across 100-150 labs from 1984-1988. Results showed consistent assay variability, validating consensus means as reliable reference values.

    Area of Science:

    • Clinical Chemistry
    • Immunoassays
    • Tumor Marker Detection

    Background:

    • Alpha-fetoprotein (AFP) is a key tumor marker.
    • Interlaboratory variability in AFP assays necessitates quality control.
    • Standardization of AFP measurements is crucial for accurate clinical interpretation.

    Purpose of the Study:

    • To assess the analytical performance of commonly used AFP testing kits.
    • To evaluate the effectiveness of an interlaboratory quality control (QC) survey for AFP assays.
    • To establish a reliable reference value for AFP determination.

    Main Methods:

    • An interlaboratory QC survey involving 100-150 laboratories over seven cycles (1984-1988).
    • Evaluation of 11 AFP kits utilizing Enzyme Immunoassay (EIA), Radioimmunoassay (RIA), and Immunoradiometric Assay (IRMA) methods.

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  • Participants converted results to UI/ml using the WHO 1st IRP 72/225 standard.

    • Main Results:

    • Total variability (CV%) for AFP assays remained consistent, ranging from 19.9% to 24.7% throughout the QC period.
    • Recovery experiments confirmed the validity of consensus means as reference values, showing strong agreement with added AFP.
    • Analytical performance data for popular methods/kits were documented.

    Conclusions:

    • The interlaboratory QC survey effectively monitored AFP assay performance.
    • Consensus means derived from the survey serve as a valid reference for AFP measurements.
    • Standardization efforts improved the reliability of AFP tumor marker testing.