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WU Meiran, HAN Liqiao, ZHANG Qiaoxuan. Current situation of thyroid function test standardization[J]. Metrology Science and Technology. doi: 10.12338/j.issn.2096-9015.2024.0132
Citation: WU Meiran, HAN Liqiao, ZHANG Qiaoxuan. Current situation of thyroid function test standardization[J]. Metrology Science and Technology. doi: 10.12338/j.issn.2096-9015.2024.0132

Current situation of thyroid function test standardization

doi: 10.12338/j.issn.2096-9015.2024.0132
  • Received Date: 2024-04-18
  • Accepted Date: 2024-07-01
  • Rev Recd Date: 2024-06-20
  • Available Online: 2024-08-02
  • The clinical indicators for detecting thyroid function include triiodothyronine, thyroxine, free triiodothyronine, free thyroxine, thyroid stimulating hormone, thyroid peroxidase antibodies, anti-thyrotropin receptor antibody, and thyroglobulin antibodies. Thyroid illness diagnosis and therapy benefit from the standardization and consistency of thyroid function testing programs. At present, some small-molecule hormone items can already achieve standardization, but for protein detection items, due to the complexity of the measurement, there are still difficulties and challenges to achieving standardization. This article summarizes the detection methods of thyroid function examination indicators, the reasons that affect the comparability of results between different methods, and the standardization progress and problems of different detection items.
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  • [1]
    Miller WG, Greenberg N. Harmonization and Standardization: Where Are We Now?[J]. J Appl LabMed, 2021, 6(2): 510-521. doi: 10.1093/jalm/jfaa189
    [2]
    Johnson JL, Felicetta JV. Hyperthyroidism: a comprehensive review[J]. J Am Acad Nurse Pract, 1992, 4(1): 8-14. doi: 10.1111/j.1745-7599.1992.tb01105.x
    [3]
    Persani L. Clinical review: Central hypothyroidism: pathogenic, diagnostic, and therapeutic challenges[J]. J Clin Endocrinol Metab, 2012, 97(9): 3068-78. doi: 10.1210/jc.2012-1616
    [4]
    Li Y, Teng D, Ba J, et al. Efficacy and Safety of LongTerm Universal Salt lodization on Thyroid Disorders Epidemiolodical Evidence from 31 Provinces of Mainland China[J]. Thvroid, 2020, 30(4): 568-579.
    [5]
    Caturegli P, De Remigis A, Rose NR. Hashimoto thyroiditis: clinical and diagnostic criteria[J]. Autoimmun Rev, 2014, 13(4-5): 391-7. doi: 10.1016/j.autrev.2014.01.007
    [6]
    Wong R, Farrell SG, Grossmann M. Thyroid nodules: diagnosis and management[J]. Med J Aust, 2018, 209(2): 92-98. doi: 10.5694/mja17.01204
    [7]
    Brent GA. Mechanisms of thyroid hormone action[J]. J Clin Invest, 2012, 122(9): 3035-43. doi: 10.1172/JCI60047
    [8]
    Mullur R, Liu YY, Brent GA. Thyroid hormone regulation of metabolism[J]. Physiol Rev, 2014, 94(2): 355-82. doi: 10.1152/physrev.00030.2013
    [9]
    Zoeller RT, Tan SW, Tyl RW. General background on the hypothalamic-pituitary-thyroid (HPT) axis[J]. Crit Rev Toxicol, 2007, 37(1-2): 11-53. doi: 10.1080/10408440601123446
    [10]
    Schussler GC. The thyroxine-binding proteins[J]. Thyroid, 1990, 1(1): 25-34. doi: 10.1089/thy.1990.1.25
    [11]
    Midgley JE. The free thyroid hormone hypothesis and measurement of free hormones[J]. Clin Chem, 1993, 39(6): 1342-4. doi: 10.1093/clinchem/39.6.1342
    [12]
    宋立军. 促甲状腺激素(TSH)检测方法小析[J]. 科技创新导报, 2012(19): 4-5,8. doi: 10.3969/j.issn.1674-098X.2012.19.003
    [13]
    王婷婷, 陆汉魁. 促甲状腺激素检测研究现状及进展[J]. 医学综述, 2016, 22(24): 4895-4898. doi: 10.3969/j.issn.1006-2084.2016.24.029
    [14]
    周静, 蒋志建, 孙奇真. 放射免疫分析法与自动化学发光免疫分析法对甲状腺抗体检测结果的比较[J]. 安徽预防医学杂志, 2018, 24(1): 71-73.
    [15]
    朱俊辉, 韩东, 刘凤林, 等. 定量检测抗甲状腺球蛋白抗体的磁微粒吖啶酯化学发光免疫检测方法的建立与初步应用[J]. 检验医学与临床, 2022, 19(22): 3073-3076,3080. doi: 10.3969/j.issn.1672-9455.2022.22.013
    [16]
    彭鸣亚, 徐龙宝, 邓民斌, 等. ECLIA法与RRA法检测血清促甲状腺激素受体抗体的对比研究[J]. 中国医药指南, 2011, 9(20): 186-187. doi: 10.3969/j.issn.1671-8194.2011.20.136
    [17]
    李金义, 刘朝基, 赵洁, 等. 不同免疫检测系统测定促甲状腺激素的差异及符合率评估[J]. 检验医学与临床, 2016, 13(22): 3250-3252. doi: 10.3969/j.issn.1672-9455.2016.22.050
    [18]
    Steele BW, Wang E, Klee GG, et al. Analytic bias of thyroid func- tion tests: analysis ofa College of American Pathologists fresh fro-zen serum pool by 3900 clinical laboratories[J]Arch Pathol Lab Med, 2005, 129(3): 310-7.
    [19]
    刘岩, 薛建军, 高蕊, 等. 不同免疫检测系统对TSH检测结果的差异性及原因初探[J]. 标记免疫分析与临床, 2021, 28(1): 41-45.
    [20]
    陈逗逗, 李田田, 刘坤钰, 等. 两种方法检测促甲状腺激素受体抗体的定量对比研究[J]. 南京医科大学学报(自然科学版), 2022, 42(1): 125-128. doi: 10.7655/NYDXBNS20220124
    [21]
    张明, 王喜青, 汪静. 两种检测方法测定抗甲状腺球蛋白抗体和抗甲状腺过氧化物酶抗体结果的比较[J]. 标记免疫分析与临床, 2014, 21(6): 722-725.
    [22]
    ISO 17511. In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned tocalibrators, trueness control materials and human samples[S]. International Organization for Standardization, 2020.
    [23]
    ISO 21151. In vitro diagnostic medical devices - Requirements for international harmonization protocols establishing metrological traceability of values assigned to calibrators and human samples[S]. International Organization for Standardization, 2020.
    [24]
    郑铁生, 鄢盛恺. 临床生物化学检验[M]. 北京: 中国医药科技出版社, 2020.
    [25]
    Thienpont LM, Van Uytfanghe K, Beastall G, et al. Report of the IFCC Working Group for Standardization of Thyroid Function Tests; part 2: free thyroxine and free triiodothyronine[J]. Clin Chem, 2010, 56(6): 912-20. doi: 10.1373/clinchem.2009.140194
    [26]
    Tai SS, Bunk DM, White E 5th, et al. Development and evaluation of a reference measurement procedure for the determination of total 3, 3', 5-triiodothyronine in human serum using isotope-dilution liquid chromatography-tandem mass spectrometry[J]. Anal Chem, 2004, 76(17): 5092-6. doi: 10.1021/ac049516h
    [27]
    Thienpont LM, Fierens C, De Leenheer AP, et al. Isotope dilution-gas chromatography/mass spectrometry and liquid chromatography/electrospray ionization-tandem mass spectrometry for the determination of triiodo-L-thyronine in serum[J]. Rapid Commun Mass Spectrom, 1999, 13(19): 1924-31. doi: 10.1002/(SICI)1097-0231(19991015)13:19<1924::AID-RCM734>3.0.CO;2-U
    [28]
    Tai SS, Sniegoski LT, Welch MJ. Candidate reference method for total thyroxine in human serum: use of isotope-dilution liquid chromatography-mass spectrometry with electrospray ionization[J]. Clin Chem, 2002, 48(4): 637-42. doi: 10.1093/clinchem/48.4.637
    [29]
    Hopley CJ, Stokes P, Webb KS, et al. The analysis of thyroxine in human serum by an 'exact matching' isotope dilution method with liquid chromatography/tandem mass spectrometry[J]. Rapid Commun Mass Spectrom, 2004, 18(10): 1033-8. doi: 10.1002/rcm.1441
    [30]
    Siekmann L. Measurement of thyroxine in human serum by isotope dilution mass spectrometry. Definitive methods in clinical chemistry, V[J]. Biomed Environ Mass Spectrom, 1987, 14(11): 683-8. doi: 10.1002/bms.1200141120
    [31]
    Thienpont LM, De Brabandere VI, Stöckl D, et al. Development of a new method for the determination of thyroxine in serum based on isotope dilution gas chromatography mass spectrometry[J]. Biol Mass Spectrom, 1994, 23(8): 475-82. doi: 10.1002/bms.1200230804
    [32]
    Midgley JE. Direct and indirect free thyroxine assay methods: theory and practice[J]. Clin Chem, 2001, 47(8): 1353-63. doi: 10.1093/clinchem/47.8.1353
    [33]
    Sterling K, Hegedus A. Measurement of free thyroxine concentration in human serum[J]. J Clin Invest, 1962, 41(5): 1031-40. doi: 10.1172/JCI104553
    [34]
    Yue B, Rockwood AL, Sandrock T, et al. Free thyroid hormones in serum by direct equilibrium dialysis and online solid-phase extraction--liquid chromatography/tandem mass spectrometry[J]. Clin Chem, 2008, 54(4): 642-51.
    [35]
    Holm SS, Hansen SH, Faber J, et al. Reference methods for the measurement of free thyroid hormones in blood: evaluation of potential reference methods for free thyroxine[J]. Clin Biochem, 2004, 37(2): 85-93. doi: 10.1016/j.clinbiochem.2003.09.009
    [36]
    Clinical Laboratory and Standards Institute (CLSI). Measurement of Free Thyroid Hormones; Approved Guideline: CLSI document C45-A [S]. USA: Clinical Laboratory and Standards Institute, 2004.
    [37]
    Van Houcke SK, Van Uytfanghe K, Shimizu E, et al. IFCC international conventional reference procedure for the measurement of free thyroxine in serum: International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group for Standardization of Thyroid Function Tests (WG-STFT)(1)[J]. Clin Chem Lab Med, 2011, 49(8): 1275-1281. doi: 10.1515/CCLM.2011.639
    [38]
    Ribera A, Zhang L, Dabbs-Brown A, et al. Development of an equilibrium dialysis ID-UPLC-MS/MS candidate reference measurement procedure for free thyroxine in human serum[J]. Clin Biochem, 2023, 116: 42-51. doi: 10.1016/j.clinbiochem.2023.03.010
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