ArticleClinical biochemistry2023
Development of an equilibrium dialysis ID-UPLC-MS/MS candidate reference measurement procedure for free thyroxine in human serum.
Article in Clinical biochemistry, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.
- 2026 ETA guideline on interference in immunoassay measurements used in assessment of thyroid function.European thyroid journal · 2026Guideline
- Highly specific ID-UHPLC-MS/MS method for analyzing polar and non-polar steroid hormones.Analytical and bioanalytical chemistry · 2026Article
- Evaluation of the Current State of Thyroid Hormone Testing in Human Serum-Results of the Free Thyroxine and Thyrotropin Interlaboratory Comparison Study.Thyroid : official journal of the American Thyroid Association · 2025Article
- Aptamer-antibody sandwich immunosensor for electrochemical detection of FT4.Mikrochimica acta · 2025Article
- Practical considerations for accurate determination of free thyroxine by equilibrium dialysis.Journal of mass spectrometry and advances in the clinical lab · 2023Article
- Analysis of free, unbound thyroid hormones by liquid chromatography-tandem mass spectrometry: A mini-review of the medical rationale and analytical methods.Analytical science advances · 2023Review
Corrections and comments
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Authors and funding
11 authors at 3 institutions in 3 countries.
Funding
Abstract
backgroundAccurate and reliable measurement of human serum free thyroxine (FT4) is critical for the diagnosis and treatment of thyroid diseases. However, concerns have been raised regarding the performance of FT4 measurements in patient care. Centers for Disease Control and Prevention Clinical Standardization Programs (CDC-CSP) address these concerns by creating a FT4 standardization program to standardize FT4 measurements. The study aims to develop a highly accurate and precise candidate Reference Measurement Procedure (cRMP), as one key component of CDC-CSP, for standardization of FT4 measurements.
methodsSerum FT4 was separated from protein-bound thyroxine with equilibrium dialysis (ED) following the recommended conditions in the Clinical and Laboratory Standards Institute C45-A guideline and the published RMP [20,21,23]. FT4 in dialysate was directly quantified with liquid chromatography-tandem mass spectrometry (LC-MS/MS) without derivatization. Gravimetric measurements of specimens and calibrator solutions, calibrator bracketing, isotope dilution, enhanced chromatographic resolution, and T4 specific mass transitions were used to ensure the accuracy, precision, and specificity of the cRMP.
resultsThe described cRMP agreed well with the established RMP and two other cRMPs in an interlaboratory comparison study. The mean biases of each method to the overall laboratory mean were within ±2.5%. The intra-day, inter-day, and total imprecision for the cRMP were within 4.4%. The limit of detection was 0.90 pmol/L, which was sufficiently sensitive to determine FT4 for patients with hypothyroidism. The structural analogs of T4 and endogenous components in dialysate did not interfere with the measurements.
conclusionOur ED-LC-MS/MS cRMP provides high accuracy, precision, specificity, and sensitivity for FT4 measurement. The cRMP can serve as a higher-order standard for establishing measurement traceability and provide an accuracy base for the standardization of FT4 assays.
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