Free thyroid hormone: Methods and standardization

IF 3.2 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Clinica Chimica Acta Pub Date : 2024-09-06 DOI:10.1016/j.cca.2024.119944
Zijia Ma , Zhenni Liu , Yuhang Deng , Xuanchang Bai , Weiyan Zhou , Chuanbao Zhang
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Abstract

Free thyroid hormone (FTH) serves as the preferred indicator for the clinical assessment of thyroid function, mainly encompassing free thyroxine and free triiodothyronine. The immunoassay commonly employed in the clinical setting exhibits certain unresolvable deficiencies. The results of over 5,500 clinical laboratories for FTH from China in 2024 demonstrated that the outcomes of immunoassay were not comparable, with robust CVs calculated in accordance with ISO 13528 ranging from 13.82% to 21.42%. Establishing reference methods is an important tool to achieve accurate and comparable results of free hormones. Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) holds a distinct advantage in the precise detection of small molecules, and two reference methods for free thyroxine based on LC-MS/MS are included in the JCTLM list. This article conducts a comprehensive review of the detection methods and standardization of FTH. It presents the metabolism of thyroid hormones, the significance of detection, the techniques, and application examples of free thyroid hormone assays, and deliberates on the current status, prospects, and recommendations for the standardization of FTH assays. Immunoassay and LC-MS/MS, as significant techniques for FTH detection, are predominantly emphasized in the case references. Ultrafiltration and equilibrium dialysis, which are utilized to separate FTH, are also addressed. This article aims to discuss the status quo of FTH detection and clarify the advantages of LC-MS/MS in FTH detection, propose that LC-MS/MS can be utilized as an auxiliary validation method or alternative method in clinical applications, and offer suggestions for the standardization of testing results.

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游离甲状腺激素:方法和标准化。
游离甲状腺激素(FTH)是临床评估甲状腺功能的首选指标,主要包括游离甲状腺素和游离三碘甲状腺原氨酸。临床上常用的免疫测定方法存在一些无法解决的缺陷。2024 年中国 5500 多家临床实验室的 FTH 检测结果表明,免疫测定的结果不具可比性,按照 ISO 13528 标准计算的稳健 CV 为 13.82% 至 21.42%。建立参考方法是实现游离激素检测结果准确性和可比性的重要工具。液相色谱-串联质谱法(LC-MS/MS)在精确检测小分子方面具有明显的优势,两种基于 LC-MS/MS 的游离甲状腺素参考方法已被列入 JCTLM 列表。本文对 FTH 的检测方法和标准化进行了全面综述。文章介绍了甲状腺激素的代谢、检测的意义、技术以及游离甲状腺激素检测的应用实例,并对 FTH 检测的现状、前景和标准化建议进行了探讨。免疫测定和 LC-MS/MS 作为 FTH 检测的重要技术,在案例参考中得到了重点强调。超滤和平衡透析也被用于分离 FTH。本文旨在探讨 FTH 检测的现状,阐明 LC-MS/MS 在 FTH 检测中的优势,提出 LC-MS/MS 在临床应用中可作为辅助验证方法或替代方法,并对检测结果的标准化提出建议。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Clinica Chimica Acta
Clinica Chimica Acta 医学-医学实验技术
CiteScore
10.10
自引率
2.00%
发文量
1268
审稿时长
23 days
期刊介绍: The Official Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Clinica Chimica Acta is a high-quality journal which publishes original Research Communications in the field of clinical chemistry and laboratory medicine, defined as the diagnostic application of chemistry, biochemistry, immunochemistry, biochemical aspects of hematology, toxicology, and molecular biology to the study of human disease in body fluids and cells. The objective of the journal is to publish novel information leading to a better understanding of biological mechanisms of human diseases, their prevention, diagnosis, and patient management. Reports of an applied clinical character are also welcome. Papers concerned with normal metabolic processes or with constituents of normal cells or body fluids, such as reports of experimental or clinical studies in animals, are only considered when they are clearly and directly relevant to human disease. Evaluation of commercial products have a low priority for publication, unless they are novel or represent a technological breakthrough. Studies dealing with effects of drugs and natural products and studies dealing with the redox status in various diseases are not within the journal''s scope. Development and evaluation of novel analytical methodologies where applicable to diagnostic clinical chemistry and laboratory medicine, including point-of-care testing, and topics on laboratory management and informatics will also be considered. Studies focused on emerging diagnostic technologies and (big) data analysis procedures including digitalization, mobile Health, and artificial Intelligence applied to Laboratory Medicine are also of interest.
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