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Evaluation of harmonization among thyroid hormone testing systems: A comparative study based on external quality

Lirui Kong^1,2, Yanqun Liu^1,2, Chaoqiong Zhou^1,2

¹Department of Clinical Laboratory, Chengdu Pidu District Hospital of Traditional Chinese Medicine, China.

Practical Laboratory Medicine

|July 24, 2025

Summary

External quality assessment (EQA) data reveal inconsistent harmonization for thyroid hormone tests (T3, T4, FT3, FT4) in laboratories, highlighting areas for quality improvement and better data interoperability.

Keywords:

External quality assessment Harmonization level Peer group Thyroid hormones Total allowable error

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Area of Science:

Clinical Chemistry
Laboratory Medicine
Quality Assurance

Background:

Thyroid hormone testing is crucial for diagnosing and managing endocrine disorders.
Harmonization of thyroid hormone assays is essential for accurate clinical interpretation and inter-laboratory comparisons.
External Quality Assessment (EQA) provides a framework for monitoring laboratory performance and identifying areas for improvement.

Purpose of the Study:

To evaluate the harmonization of thyroid hormone tests (T3, T4, FT3, FT4, TSH) using EQA data.
To guide laboratory quality enhancement initiatives.
To assess the potential for big data interoperability in thyroid hormone testing.

Main Methods:

Collected EQA data for T3, T4, FT3, FT4, and TSH from January 2022 to December 2024.
Calculated total allowable error (TEa) for the laboratory (TEa-Lab) and peer groups (TEa-peer).
Derived harmonization indices (HI) by comparing TEa values against biological variation thresholds (minimum, desirable, optimal).

Main Results:

Thyroid-stimulating hormone (TSH) testing demonstrated desirable harmonization (HI ≤ 1).
Harmonization indices for T3, T4, FT3, and FT4 ranged from 1.1 to 1.9, indicating suboptimal harmonization.
Peer group analyses showed variable coordination among testing systems, with harmonization levels ranging widely.
Harmonization levels between the laboratory and peer groups for thyroid hormones exhibited strong consistency.

Conclusions:

Harmonization indices derived from EQA data quantitatively reflect the consistency of thyroid hormone testing systems.
This approach aids in identifying laboratory-specific issues and implementing corrective actions.
The findings provide a valuable reference for enhancing laboratory big data interoperability and supporting clinical decision-making.