Institute for Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, University Hospital, University of Leipzig, Leipzig, Germany.
Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.
Clin Chem Lab Med. 2020 Dec 24;59(6):1013-1023. doi: 10.1515/cclm-2020-1696. Print 2021 May 26.
Results can vary between different free thyroxine (FT4) assays; global standardization would improve comparability of results between laboratories, allowing development of common clinical decision limits in evidence-based guidelines.
We summarize the path to standardization of FT4 assays, and challenges associated with FT4 testing in special populations, including the need for collaborative efforts toward establishing population-specific reference intervals. The International Federation of Clinical Chemistry and Laboratory Medicine Committee for Standardization of Thyroid Function Tests has undertaken FT4 immunoassay method comparison and recalibration studies and developed a reference measurement procedure that is currently being validated. Further studies are needed to establish common reference intervals/clinical decision limits. Standardization of FT4 assays will change test results substantially; therefore, a major education program will be required to ensure stakeholders are aware of the benefits of FT4 standardization, planned transition procedure, and potential clinical impact of the changes. Assay recalibration by manufacturers and approval process simplification by regulatory authorities will help minimize the clinical impact of standardization.
Significant progress has been made toward standardization of FT4 testing, but technical and logistical challenges remain.
Collaborative efforts by manufacturers, laboratories, and clinicians are required to achieve successful global standardization of the FT4 assays.
不同游离甲状腺素（FT4）检测方法的结果可能存在差异；全球标准化将提高实验室间结果的可比性，允许在基于证据的指南中制定共同的临床决策界限。
我们总结了 FT4 检测方法标准化的途径，以及特殊人群中 FT4 检测所面临的挑战，包括需要合作努力建立特定人群的参考区间。国际临床化学和实验室医学联合会甲状腺功能检测标准化委员会已经开展了 FT4 免疫测定方法比较和重新校准研究，并开发了目前正在验证的参考测量程序。还需要进一步的研究来建立共同的参考区间/临床决策界限。FT4 检测方法的标准化将大大改变检测结果；因此，需要进行大规模的教育计划，以确保利益相关者了解 FT4 标准化的益处、计划的过渡程序以及这些变化的潜在临床影响。制造商的检测重新校准和监管机构的简化审批程序将有助于最大程度地减少标准化的临床影响。
FT4 检测的标准化已经取得了重大进展，但仍存在技术和后勤方面的挑战。
制造商、实验室和临床医生需要共同努力，才能成功实现 FT4 检测的全球标准化。
