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Description and validation of an equilibrium dialysis ID-LC-MS/MS candidate reference measurement procedure for free thyroxine in human serum

Heleen I. Jansen, Rob van der Steen, André Brandt, André J. Olthaar, Hubert W. Vesper, Eri Shimizu, Annemieke C. Heijboer, Katleen Van Uytfanghe (UGent) and Antonius E. van Herwaarden
(2023) CLINICAL CHEMISTRY AND LABORATORY MEDICINE. 61(9). p.1605-1611
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Abstract
Objectives Free thyroxine (FT4) in serum is routinely measured in clinical practice to diagnose and monitor thyroid disease. Due to its concentration in picomolar range and the delicate equilibrium of free and protein-bound T4, accurate measurement is challenging. As a consequence, large inter-method differences in FT4 results exists. Optimal method design and standardization of the FT4 measurement is therefore necessary. The IFCC Working Group for Standardization of Thyroid Function Tests proposed a reference system with a conventional reference measurement procedure (cRMP) for FT4 in serum. In this study, we describe our FT4 candidate cRMP and its validation in clinical samples.Methods This candidate cRMP is based on equilibrium dialysis (ED) combined with determination of T4 with an isotope-dilution liquid chromatography tandem mass-spectrometry (ID-LC-MS/MS) procedure and was developed according to the endorsed conventions. Its accuracy, reliability, and comparability was investigated using human sera.Results It was shown that the candidate cRMP adhered to the conventions and its accuracy, precision, and robustness were adequate in serum of healthy volunteers.Conclusions Our candidate cRMP measures FT4 accurately and performs well in serum matrix.
Keywords
conventional reference measurement procedure, free thyroxine, LC-MS, MS, standardization, THYROID-FUNCTION TESTS, MASS-SPECTROMETRY, STANDARDIZATION

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MLA
Jansen, Heleen I., et al. “Description and Validation of an Equilibrium Dialysis ID-LC-MS/MS Candidate Reference Measurement Procedure for Free Thyroxine in Human Serum.” CLINICAL CHEMISTRY AND LABORATORY MEDICINE, vol. 61, no. 9, 2023, pp. 1605–11, doi:10.1515/cclm-2022-1134.
APA
Jansen, H. I., van der Steen, R., Brandt, A., Olthaar, A. J., Vesper, H. W., Shimizu, E., … van Herwaarden, A. E. (2023). Description and validation of an equilibrium dialysis ID-LC-MS/MS candidate reference measurement procedure for free thyroxine in human serum. CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 61(9), 1605–1611. https://doi.org/10.1515/cclm-2022-1134
Chicago author-date
Jansen, Heleen I., Rob van der Steen, André Brandt, André J. Olthaar, Hubert W. Vesper, Eri Shimizu, Annemieke C. Heijboer, Katleen Van Uytfanghe, and Antonius E. van Herwaarden. 2023. “Description and Validation of an Equilibrium Dialysis ID-LC-MS/MS Candidate Reference Measurement Procedure for Free Thyroxine in Human Serum.” CLINICAL CHEMISTRY AND LABORATORY MEDICINE 61 (9): 1605–11. https://doi.org/10.1515/cclm-2022-1134.
Chicago author-date (all authors)
Jansen, Heleen I., Rob van der Steen, André Brandt, André J. Olthaar, Hubert W. Vesper, Eri Shimizu, Annemieke C. Heijboer, Katleen Van Uytfanghe, and Antonius E. van Herwaarden. 2023. “Description and Validation of an Equilibrium Dialysis ID-LC-MS/MS Candidate Reference Measurement Procedure for Free Thyroxine in Human Serum.” CLINICAL CHEMISTRY AND LABORATORY MEDICINE 61 (9): 1605–1611. doi:10.1515/cclm-2022-1134.
Vancouver
1.
Jansen HI, van der Steen R, Brandt A, Olthaar AJ, Vesper HW, Shimizu E, et al. Description and validation of an equilibrium dialysis ID-LC-MS/MS candidate reference measurement procedure for free thyroxine in human serum. CLINICAL CHEMISTRY AND LABORATORY MEDICINE. 2023;61(9):1605–11.
IEEE
[1]
H. I. Jansen et al., “Description and validation of an equilibrium dialysis ID-LC-MS/MS candidate reference measurement procedure for free thyroxine in human serum,” CLINICAL CHEMISTRY AND LABORATORY MEDICINE, vol. 61, no. 9, pp. 1605–1611, 2023.
@article{01HXVN4SD9R6P4XBPJ7CVXQZXH,
  abstract     = {{Objectives Free thyroxine (FT4) in serum is routinely measured in clinical practice to diagnose and monitor thyroid disease. Due to its concentration in picomolar range and the delicate equilibrium of free and protein-bound T4, accurate measurement is challenging. As a consequence, large inter-method differences in FT4 results exists. Optimal method design and standardization of the FT4 measurement is therefore necessary. The IFCC Working Group for Standardization of Thyroid Function Tests proposed a reference system with a conventional reference measurement procedure (cRMP) for FT4 in serum. In this study, we describe our FT4 candidate cRMP and its validation in clinical samples.Methods This candidate cRMP is based on equilibrium dialysis (ED) combined with determination of T4 with an isotope-dilution liquid chromatography tandem mass-spectrometry (ID-LC-MS/MS) procedure and was developed according to the endorsed conventions. Its accuracy, reliability, and comparability was investigated using human sera.Results It was shown that the candidate cRMP adhered to the conventions and its accuracy, precision, and robustness were adequate in serum of healthy volunteers.Conclusions Our candidate cRMP measures FT4 accurately and performs well in serum matrix.}},
  author       = {{Jansen, Heleen I. and  van der Steen, Rob and Brandt, André and Olthaar, André J. and  Vesper, Hubert W. and  Shimizu, Eri and  Heijboer, Annemieke C. and Van Uytfanghe, Katleen and  van Herwaarden, Antonius E.}},
  issn         = {{1434-6621}},
  journal      = {{CLINICAL CHEMISTRY AND LABORATORY MEDICINE}},
  keywords     = {{conventional reference measurement procedure,free thyroxine,LC-MS,MS,standardization,THYROID-FUNCTION TESTS,MASS-SPECTROMETRY,STANDARDIZATION}},
  language     = {{eng}},
  number       = {{9}},
  pages        = {{1605--1611}},
  title        = {{Description and validation of an equilibrium dialysis ID-LC-MS/MS candidate reference measurement procedure for free thyroxine in human serum}},
  url          = {{http://doi.org/10.1515/cclm-2022-1134}},
  volume       = {{61}},
  year         = {{2023}},
}
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