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Related Experiment Videos

Error in laboratory reference limits as shown in a collaborative quality-assurance program.

P J Compton, M C Stuart, L Lazarus

    Clinical Chemistry
    |May 1, 1986
    PubMed
    Summary
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    Laboratory reference intervals for diagnostic assays like thyroid immunoassays show poor correlation with assay bias. Standardized national or international reference limits could improve diagnostic quality and reduce costs.

    Area of Science:

    • Clinical Chemistry
    • Laboratory Medicine
    • Diagnostic Assays

    Background:

    • Quality assurance programs are crucial for maintaining diagnostic assay quality.
    • However, the quality of reference intervals used in these programs has been overlooked.
    • Thyroid immunoassays (triiodothyronine, thyroxin, thyrotropin) are commonly used diagnostic tests.

    Purpose of the Study:

    • To assess the quality of laboratory reference intervals within a national quality assurance program.
    • To evaluate the relationship between reference interval limits and assay bias in common immunoassays.

    Main Methods:

    • Utilized data from a national quality assurance program.
    • Analyzed reference intervals for triiodothyronine, thyroxin, and thyrotropin immunoassays.

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  • Assessed the correlation between reference limits and laboratory assay bias.

    • Main Results:

    • Reference interval limits showed minimal relationship to laboratory bias (assay "high" or "low" readings).
    • Adjusting assay results using different laboratory reference limits increased, not decreased, interlaboratory variability.
    • The analytical performance of immunoassays surpassed the diagnostic utility of current reference limits.

    Conclusions:

    • Current laboratory-specific reference limits offer limited diagnostic value and do not reflect assay bias.
    • Standardized national or international reference intervals would enhance diagnostic information.
    • Implementing defined reference limits could be more cost-effective than individual laboratory limits.