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Synthesis and Regulation of Thyroid Hormones01:20

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Low blood levels of the thyroid hormones — triiodothyronine (T3) and thyroxine (T4) — signal the hypothalamus to release the thyrotropin-releasing hormone (TRH). TRH then reaches the pituitary gland and stimulates the release of thyroid-stimulating hormone(TSH) into the bloodstream.
Upon reaching the thyroid gland, TSH stimulates the follicular cells' active uptake of iodide ions from the blood. The ions diffuse to the apical surface of the cells and are oxidized to iodine. The...
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Harmonization of thyroid function test measurements across multiple immunoassay platforms for a common reference

Gyu Won Cho1, Min-Jeong Kim2, Min Young Lee3

  • 1Department of Laboratory Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Korea.

Laboratory Medicine
|April 4, 2026
PubMed
Summary

Harmonizing thyroid function test reference intervals using recalibration significantly improved consistency for thyrotropin (TSH) and free thyroxine (FT4). This approach enhances clinical interpretation despite limitations with triiodothyronine (T3).

Keywords:
harmonizationreference intervalthyroid function test

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Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Endocrinology

Background:

  • Thyroid function test reference intervals vary significantly across immunoassay platforms.
  • This variability leads to inconsistent clinical interpretations and potential diagnostic errors.
  • Establishing harmonized reference intervals is crucial for accurate patient assessment.

Purpose of the Study:

  • To establish a harmonized common reference interval for thyroid function tests (thyrotropin, triiodothyronine, free thyroxine).
  • To evaluate the clinical utility and effectiveness of a recalibration method for harmonizing these intervals.
  • To improve interpretive consistency in thyroid function testing.

Main Methods:

  • Serum samples from 283 adults were analyzed on Abbott, Beckman Coulter, and Roche platforms.
  • Percentile transformation with regression-based recalibration was employed to create method-specific and common reference intervals.
  • Agreement was assessed using coefficients of variation, width ratios, overlap percentages, and limit-difference percentages.

Main Results:

  • Recalibration markedly reduced variability for thyrotropin (midpoint CV 10.7% to 2.9%) and free thyroxine (22.7% to 6.1%).
  • Triiodothyronine harmonization showed limited improvement (midpoint CV 5.1% to 9.3%) with significant lower-limit discrepancy.
  • Recalibrated intervals achieved 97% to 99% concordance, a substantial improvement over manufacturer-provided intervals.

Conclusions:

  • Percentile transformation with regression-based recalibration offers a practical and cost-effective method for harmonizing thyrotropin and free thyroxine reference intervals.
  • While triiodothyronine harmonization was limited, the study demonstrates the feasibility and clinical value of common reference intervals.
  • Harmonized intervals enhance interpretive consistency in thyroid function testing.