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Standardisation and harmonisation of thyroid-stimulating hormone measurements : historical, current, and future perspectives

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Abstract
Thyroid-stimulating hormone (TSH) is an important clinical marker in the diagnosis and management of thyroid disease. TSH measurements are reported in milli-International Units per Litre (mIU/L), traceable to a World Health Organisation (WHO) reference material. There is a wide variety of commercial immunoassays for TSH measurements available, which have historically been poorly harmonised due to a lack of commutability of the WHO reference materials with patient samples. This led to the recent development of a serum-based reference panel for TSH, traceable to the WHO reference material, available via the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC), aimed at harmonisation of TSH immunoassays. This report describes recent developments in the TSH reference system, including establishment of the 4th WHO International Standard for TSH, and aims to clarify the relationship between the available reference materials and their intended uses. This 4th WHO IS is widely available and defines the unit of TSH activity, therefore its continued existence is of paramount importance, however it continues to show a lack of commutability with patient in many TSH immunoassays. This makes the C-STFT TSH panel, albeit available in restricted numbers, a critical resource to ensure better TSH assay harmonisation.
Keywords
thyroid-stimulating hormone, standardisation, reference materials, commutability, harmonisation, IMMUNOASSAYS, TSH

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MLA
Cowper, Ben, et al. “Standardisation and Harmonisation of Thyroid-Stimulating Hormone Measurements : Historical, Current, and Future Perspectives.” CLINICAL CHEMISTRY AND LABORATORY MEDICINE, vol. 62, no. 5, 2024, pp. 824–29, doi:10.1515/cclm-2023-1332.
APA
Cowper, B., Lyle, A. N., Vesper, H. W., Van Uytfanghe, K., & Burns, C. (2024). Standardisation and harmonisation of thyroid-stimulating hormone measurements : historical, current, and future perspectives. CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 62(5), 824–829. https://doi.org/10.1515/cclm-2023-1332
Chicago author-date
Cowper, Ben, Alicia N. Lyle, Hubert W. Vesper, Katleen Van Uytfanghe, and Chris Burns. 2024. “Standardisation and Harmonisation of Thyroid-Stimulating Hormone Measurements : Historical, Current, and Future Perspectives.” CLINICAL CHEMISTRY AND LABORATORY MEDICINE 62 (5): 824–29. https://doi.org/10.1515/cclm-2023-1332.
Chicago author-date (all authors)
Cowper, Ben, Alicia N. Lyle, Hubert W. Vesper, Katleen Van Uytfanghe, and Chris Burns. 2024. “Standardisation and Harmonisation of Thyroid-Stimulating Hormone Measurements : Historical, Current, and Future Perspectives.” CLINICAL CHEMISTRY AND LABORATORY MEDICINE 62 (5): 824–829. doi:10.1515/cclm-2023-1332.
Vancouver
1.
Cowper B, Lyle AN, Vesper HW, Van Uytfanghe K, Burns C. Standardisation and harmonisation of thyroid-stimulating hormone measurements : historical, current, and future perspectives. CLINICAL CHEMISTRY AND LABORATORY MEDICINE. 2024;62(5):824–9.
IEEE
[1]
B. Cowper, A. N. Lyle, H. W. Vesper, K. Van Uytfanghe, and C. Burns, “Standardisation and harmonisation of thyroid-stimulating hormone measurements : historical, current, and future perspectives,” CLINICAL CHEMISTRY AND LABORATORY MEDICINE, vol. 62, no. 5, pp. 824–829, 2024.
@article{01HXVN4SD29SFFZWT1SW3EYHDE,
  abstract     = {{Thyroid-stimulating hormone (TSH) is an important clinical marker in the diagnosis and management of thyroid disease. TSH measurements are reported in milli-International Units per Litre (mIU/L), traceable to a World Health Organisation (WHO) reference material. There is a wide variety of commercial immunoassays for TSH measurements available, which have historically been poorly harmonised due to a lack of commutability of the WHO reference materials with patient samples. This led to the recent development of a serum-based reference panel for TSH, traceable to the WHO reference material, available via the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC), aimed at harmonisation of TSH immunoassays. This report describes recent developments in the TSH reference system, including establishment of the 4th WHO International Standard for TSH, and aims to clarify the relationship between the available reference materials and their intended uses. This 4th WHO IS is widely available and defines the unit of TSH activity, therefore its continued existence is of paramount importance, however it continues to show a lack of commutability with patient in many TSH immunoassays. This makes the C-STFT TSH panel, albeit available in restricted numbers, a critical resource to ensure better TSH assay harmonisation.}},
  author       = {{Cowper, Ben and  Lyle, Alicia N. and  Vesper, Hubert W. and Van Uytfanghe, Katleen and  Burns, Chris}},
  issn         = {{1434-6621}},
  journal      = {{CLINICAL CHEMISTRY AND LABORATORY MEDICINE}},
  keywords     = {{thyroid-stimulating hormone,standardisation,reference materials,commutability,harmonisation,IMMUNOASSAYS,TSH}},
  language     = {{eng}},
  number       = {{5}},
  pages        = {{824--829}},
  title        = {{Standardisation and harmonisation of thyroid-stimulating hormone measurements : historical, current, and future perspectives}},
  url          = {{http://doi.org/10.1515/cclm-2023-1332}},
  volume       = {{62}},
  year         = {{2024}},
}

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