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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2018: 3.638

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

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1437-4331
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Volume 53, Issue 9

Issues

Establishment of trimester-specific thyroid stimulating hormone and free thyroxine reference interval in pregnant Chinese women using the Beckman Coulter UniCel™ DxI 600

Jing Zhang
  • Corresponding author
  • Department of Laboratory Medicine, Maternity and Child Healthcare Hospital of Nanshan District, Shenzhen, P.R. China
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/ Wei Li
  • Department of Laboratory Medicine, Maternity and Child Healthcare Hospital of Nanshan District, Shenzhen, P.R. China
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/ Qiao-Bin Chen
  • Department of Laboratory Medicine, Maternity and Child Healthcare Hospital of Nanshan District, Shenzhen, P.R. China
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/ Li-Yi Liu
  • Department of Laboratory Medicine, Maternity and Child Healthcare Hospital of Nanshan District, Shenzhen, P.R. China
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/ Wei Zhang
  • Department of Laboratory Medicine, Maternity and Child Healthcare Hospital of Nanshan District, Shenzhen, P.R. China
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/ Meng-Ying Liu
  • Department of Laboratory Medicine, Maternity and Child Healthcare Hospital of Nanshan District, Shenzhen, P.R. China
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/ Yi-Ting Wang
  • Department of Laboratory Medicine, Maternity and Child Healthcare Hospital of Nanshan District, Shenzhen, P.R. China
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/ Wen-Ya Li
  • Department of Laboratory Medicine, Maternity and Child Healthcare Hospital of Nanshan District, Shenzhen, P.R. China
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/ Li-Zhen Zeng
  • Department of Laboratory Medicine, Maternity and Child Healthcare Hospital of Nanshan District, Shenzhen, P.R. China
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Published Online: 2014-12-02 | DOI: https://doi.org/10.1515/cclm-2014-0615

Abstract

Background: Thyroid-stimulating hormone (TSH) and free thyroxine (FT4) reference intervals are essential for screening and diagnosing thyroid dysfunction during pregnancy. The aim of this study was to establish method- and trimester-specific TSH and FT4 reference intervals in pregnant Chinese women using the Beckman Coulter UniCel™ DxI 600.

Methods: A cross-sectional dataset analysis was performed. A total of 3507 participants were recruited, and 2743 were eligible for analysis to set reference intervals. TSH, FT4, and thyroid peroxidase antibody (TPOAb) levels were analyzed with the Beckman Coulter UniCel™ DxI 600 Access® immunoassay system. Ranges between the 2.5th and 97.5th percentiles were defined as reference intervals for TSH and FT4.

Results: The calculated reference intervals for the first, second, and third trimesters were TSH: 0.06–3.13, 0.07–4.13 and 0.15–5.02 mIU/L, respectively, and FT4: 8.72–15.22, 7.10–13.55 and 6.16–12.03 pmol/L, respectively.

Conclusions: Our reference intervals for TSH and FT4 are distinct from the ranges reported in the DxI 600 instruction manual and previously reported data, confirming the importance of method-specific reference intervals.

Keywords: luminescent measurements; pregnancy; reference values; thyroid hormones

References

  • 1.

    Chang DL, Pearce EN. Screening for maternal thyroid dysfunction in pregnancy: a review of the clinical evidence and current guidelines. J Thyroid Res 2013;2013:851326.Google Scholar

  • 2.

    Brenta G, Vaisman M, Sgarbi JA, Bergoglio LM, de Andrada NC, Bravo PP, et al. Clinical practice guidelines for the management of hypothyroidism. Arq Bras Endocrinol Metabol 2013;57:265–91.CrossrefGoogle Scholar

  • 3.

    Bernardi LA, Scoccia B. The effects of maternal thyroid hormone function on early pregnancy. Curr Opin Obstet Gynecol 2013;25:267–73.CrossrefPubMedGoogle Scholar

  • 4.

    Haddow JE, Palomaki GE, Allan WC, Williams JR, Knight GJ, Gagnon J, et al. Maternal thyroid deficiency during pregnancy and subsequent neuropsychological development of the child. N Engl J Med 1999;341:549–55.Google Scholar

  • 5.

    Stagnaro-Green A, Abalovich M, Alexander E, Azizi F, Mestman J, Negro R, et al. Guidelines of the American Thyroid Association for the diagnosis and management of thyroid disease during pregnancy and postpartum. Thyroid 2011;21:1081–125.CrossrefWeb of ScienceGoogle Scholar

  • 6.

    Clinical and Laboratory Standards Institute. User verification of performance for precision and trueness; approved guideline, second edition. CLSI document EP15-A2 [ISBN 1-56238-574-7]. CLSI: Wayne, PA, 2005.Google Scholar

  • 7.

    NCCLS. How to define and determine reference intervals in the clinical laboratory; approved guideline, second edition. NCCLS document C28-A2 [ISBN 1-56238-406-6]. NCCLS: Wayne, PA, 2000.Google Scholar

  • 8.

    Arnold BC, Balakrishnan N, Nagaraja HN. A first course in order statistics. Part of classics in applied mathematics; 54 [ISBN 978-0-89871-648-1]. Philadelphia: Society for Industrial and Applied Mathematics, 2008:303.Google Scholar

  • 9.

    Endocrinology Branch of Chinese Medical Association, Perinatal Medicine Branch of Chinese Medical Association. Pregnancy and postpartum thyroid disease treatment guideline of China. Chin J Endocrinol Metab 2012;28:354–71.Google Scholar

  • 10.

    Santiago P, Berrio M, Olmedo P, Velasco I, Sanchez B, Garcia E, et al. Reference values for thyroid hormones in the population of pregnant women in Jaen [in Spanish]. Endocrinol Nutr 2011;58:62–7.CrossrefPubMedGoogle Scholar

  • 11.

    Haddow JE, Knight GJ, Palomaki GE, McClain MR, Pulkkinen AJ. The reference range and within-person variability of thyroid stimulating hormone during the first and second trimesters of pregnancy. J Med Screen 2004;11:170–4.PubMedCrossrefGoogle Scholar

  • 12.

    Kurioka H, Takahashi K, Miyazaki K. Maternal thyroid function during pregnancy and puerperal period. Endocr J 2005;52:587–91.PubMedCrossrefGoogle Scholar

  • 13.

    Gow SM, Kellett HA, Seth J, Sweeting VM, Toft AD, Beckett GJ. Limitations of new thyroid function tests in pregnancy. Clin Chim Acta 1985;152:325–33.Google Scholar

  • 14.

    Parker JH. Amerlex free triiodothyronine and free thyroxine levels in normal pregnancy. Br J Obstet Gynaecol 1985;92:1234–8.CrossrefPubMedGoogle Scholar

  • 15.

    Gong Y, Hoffman BR. Free thyroxine reference interval in each trimester of pregnancy determined with the Roche Modular E-170 electrochemiluminescent immunoassay. Clin Biochem 2008;41:902–6.Web of ScienceCrossrefPubMedGoogle Scholar

  • 16.

    Stricker R, Echenard M, Eberhart R, Chevailler MC, Perez V, Quinn FA, et al. Evaluation of maternal thyroid function during pregnancy: the importance of using gestational age-specific reference intervals. Eur J Endocrinol 2007;157:509–14.Web of ScienceGoogle Scholar

  • 17.

    Sapin R, d’Herbomez M. Free thyroxine measured by equilibrium dialysis and nine immunoassays in sera with various serum thyroxine-binding capacities. Clin Chem 2003;49:1531–5.Google Scholar

  • 18.

    Lambert-Messerlian G, McClain M, Haddow JE, Palomaki GE, Canick JA, Cleary-Goldman J, et al. First- and second-trimester thyroid hormone reference data in pregnant women: a FaSTER (First- and Second-Trimester Evaluation of Risk for aneuploidy) Research Consortium study. Am J Obstet Gynecol 2008;199:62e1–6.Web of ScienceGoogle Scholar

  • 19.

    La’ulu SL, Roberts WL. Second-trimester reference intervals for thyroid tests: the role of ethnicity. Clin Chem 2007;53:1658–64.CrossrefGoogle Scholar

  • 20.

    Boucai L, Surks MI. Reference limits of serum TSH and free T4 are significantly influenced by race and age in an urban outpatient medical practice. Clin Endocrinol (Oxf) 2009;70:788–93.Web of ScienceGoogle Scholar

About the article

Corresponding author: Jing Zhang, Department of Laboratory Medicine, Maternity and Child Healthcare Hospital of Nanshan District, 93 Taoyuan Road, Nanshan District, Shenzhen 518052, P.R. China. Phone: +86 0755 26557721, Fax: +86 0755 26557742, E-mail:


Received: 2014-06-12

Accepted: 2014-10-21

Published Online: 2014-12-02

Published in Print: 2015-08-01


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 53, Issue 9, Pages 1409–1414, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2014-0615.

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