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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 EMAIL logo , Wei Li , Qiao-Bin Chen , Li-Yi Liu , Wei Zhang , Meng-Ying Liu , Yi-Ting Wang , Wen-Ya Li and Li-Zhen Zeng
Published/Copyright: December 2, 2014
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 53 Issue 9

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
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:

Acknowledgments

The authors are grateful to all study participants.

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Financial support: This work is part of a program in Nanshan technology development and creative design projects of Shenzhen China, health class, grant number 201205.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Received: 2014-6-12
Accepted: 2014-10-21
Published Online: 2014-12-2
Published in Print: 2015-8-1

©2015 by De Gruyter

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  3. New trends in the long and puzzling history of HbA1c
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  33. Letters to the Editors
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https://doi.org/10.1515/cclm-2014-0615
Keywords for this article
luminescent measurements; pregnancy; reference values; thyroid hormones

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. New trends in the long and puzzling history of HbA1c
  4. Review
  5. Thyroglobulin measurement by highly sensitive assays: focus on laboratory challenges
  6. Opinion Paper
  7. Possible role of fructosamine 3-kinase genotyping for the management of diabetic patients
  8. EFLM Original Article
  9. Compliance of blood sampling procedures with the CLSI H3-A6 guidelines: An observational study by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PRE)
  10. Genetics and Molecular Diagnostics
  11. Quantitative-fluorescent-PCR versus full karyotyping in prenatal diagnosis of common chromosome aneuploidies in southern Spain
  12. HIF1A and MIF as potential predictive mRNA biomarkers of pre-eclampsia: a longitudinal prospective study in high risk population
  13. General Clinical Chemistry and Laboratory Medicine
  14. Evidence of Crohn’s disease-related anti-glycoprotein 2 antibodies in patients with celiac disease
  15. Myocardial interleukin-6 in the setting of left ventricular mechanical assistance: relation with outcome and C-reactive protein
  16. Different methods to estimate serum free cortisol: a comparison during cortisol tetracosactide testing
  17. Automated immunoassays for the autoantibodies to carbamylated or citrullinated telopeptides of type I and II collagens
  18. Relevance of correction for drift and day-to-day variation in cystatin C measurement: a post-hoc analysis of the PREVEND cohort, with independent replication in the ESTHER cohort
  19. Laboratory utilization improvement through a computer-aided algorithm developed with general practitioners
  20. Quantitation of 1α,25-dihydroxyvitamin D by LC-MS/MS using solid-phase extraction and fixed-charge derivitization in comparison to immunoextraction
  21. Reference Values and Biological Variations
  22. Establishment of trimester-specific thyroid stimulating hormone and free thyroxine reference interval in pregnant Chinese women using the Beckman Coulter UniCel™ DxI 600
  23. Cancer Diagnostics
  24. Expression of vascular endothelial factor-A, gelatinases (MMP-2, MMP-9) and TIMP-1 in uterine leiomyomas
  25. Influence of ABO type on global coagulation assay results: effect of coagulation factor VIII
  26. Diabetes
  27. Benchmarking by HbA1c in a national diabetes quality register – does measurement bias matter?
  28. Comparing HbA1c, fasting and 2-h plasma glucose for screening for abnormal glucose regulation in patients undergoing coronary angiography
  29. Erroneous HbA1c measurements in the presence of β-thalassemia and common Chinese hemoglobin variants
  30. Using the likelihood ratio to evaluate allowable total error – an example with glycated hemoglobin (HbA1c)
  31. Two novel haemoglobin variants that affect haemoglobin A1c measurement by ion-exchange chromatography
  32. Analytical performances of the D-100TM hemoglobin testing system (Bio-Rad) for HbA1c assay
  33. Letters to the Editors
  34. Glycation rate of haemoglobins S, C, D, E, J and G, and analytical interference on the measurement of HbA1c with affinity chromatography and capillary electrophoresis
  35. Hemoglobin Valme HBB:c.124T>G: a new hemoglobin variant with diminished oxygen affinity causes interference in hemoglobin A1c measurement in an automated ion-exchange HPLC method
  36. Hemoglobin A1c reported in units and diagnostic cut-offs in relation to the international recommendations
  37. Hemoglobin measurements in samples containing hemoglobin-based oxygen carriers
  38. Serologic false-positive reactions for syphilis in children of allergic purpura
  39. Exploration of the pre-analytical stability of β-lactam antibiotics in plasma and blood – implications for therapeutic drug monitoring and pharmacokinetic studies
  40. Fungal contamination of hyaluronidase solution mimicking fungal joint infection: a preanalytical pitfall in synovial fluid analysis
  41. Stroke and inherited thrombophilia in a Tunisian girl with sickle cell anemia
  42. Faecal haemoglobin concentrations do vary across geography as well as with age and sex: ramifications for colorectal cancer screening
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