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[Harmonization of TSH Measurements.]

Keiko Takeoka, Yoh Hidaka, Akira Hishinuma

    Rinsho Byori. the Japanese Journal of Clinical Pathology
    |November 29, 2017
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    Summary

    Thyroid stimulating hormone (TSH) levels vary between assays. This study developed formulas to harmonize TSH measurements, eliminating discrepancies and ensuring accurate clinical decisions until international standardization is achieved.

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    Area of Science:

    • Clinical Chemistry
    • Laboratory Medicine
    • Endocrinology

    Background:

    • Thyroid stimulating hormone (TSH) measurements vary significantly based on the immunoassay reagents used.
    • Clinical practice guidelines rely on absolute TSH decision limits, making assay harmonization critical for accurate patient management.

    Purpose of the Study:

    • To harmonize thyroid stimulating hormone (TSH) measurements across different immunoassays.
    • To develop recalculation formulas to eliminate between-assay discrepancies in TSH concentrations.

    Main Methods:

    • TSH was measured in 146 serum samples using four different immunoassays.
    • The all-procedure trimmed mean method was employed for harmonization.
    • Recalculation formulas were derived for each assay to standardize reported TSH concentrations.

    Main Results:

    • Significant differences in TSH concentrations were observed between the four immunoassays, with E test TOSOH yielding the highest and LUMIPULSE the lowest values.
    • Recalculation using the derived formulas effectively eliminated the observed between-assay discrepancies.
    • Specific formulas were established for E test TOSOH, ECLusys, ARCHITECT, and LUMIPULSE assays.

    Conclusions:

    • The developed recalculation formulas provide a method for harmonizing TSH measurements until international standardization by IFCC is achieved.
    • Accurate and consistent TSH reporting is essential for maintaining the integrity of clinical decision-making in thyroid function testing.