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Gestational age-specific reference ranges from different laboratories misclassify pregnant women's thyroid status

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Authors:
  • Bliddal, Sofie ;
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    Department of Endocrinology, Section 2132, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark.
  • Feldt-Rasmussen, Ulla ;
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    Department of Clinical Medicine, Department of Clinical Medicine, Faculty of Health and Medical Sciences, Københavns Universitet
  • Boas, Malene ;
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    unknown
  • Faber, Jens ;
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    Department of Clinical Medicine, Department of Clinical Medicine, Faculty of Health and Medical Sciences, Københavns Universitet
  • Juul, Anders ;
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    Orcid logo0000-0002-0534-4350
    Department of Clinical Medicine, Department of Clinical Medicine, Faculty of Health and Medical Sciences, Københavns Universitet
  • Larsen, Torben ;
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    Department of Clinical Medicine, Department of Clinical Medicine, Faculty of Health and Medical Sciences, Københavns Universitet
  • Precht, Dorthe Hansen
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    unknown
Subtitle:
comparison of two longitudinal prospective cohort studies
DOI:
10.1530/EJE-13-0672
Abstract:
OBJECTIVES: Correct interpretation of thyroid status during pregnancy is vital to secure fetal development. Pregnancy-related changes in maternal thyroid status necessitate the use of gestational age-specific reference ranges. In this study, we investigated between-laboratory reproducibility of thyroid reference ranges in pregnant women. DESIGN: Comparison of two longitudinal prospective cohort studies including 255 (cohort 1) and 101 (cohort 2) healthy antibody-negative Danish pregnant women attending prenatal care at Copenhagen University Hospital. METHODS: Different immunoassays were used to measure thyroid hormone levels in the two cohorts. Thyroid hormone reference ranges were established for every 5 weeks of gestation. Differences between cohorts were explored through mixed-model repeated measures regression analyses. By applying reference ranges from one cohort to the other, the proportion of women who would be misclassified by doing so was investigated. RESULTS: TSH increased and free thyroxine (FT4) decreased as pregnancy progressed. Results indicated highly significant differences between cohorts in free triiodothyronine (F=21.3, P<0.001) and FT4 (F=941, P<0.001). TSH levels were comparable (P=0.09). Up to 90.3% of the women had FT4 levels outside their laboratory's nonpregnant reference range, and up to 100% outside the other cohort's gestational-age-specific reference ranges. Z-score-based reference ranges markedly improved comparison between cohorts. CONCLUSION: Even in the same region, the use of gestational-age-specific reference ranges from different laboratories led to misclassification. Up to 100% of maternal FT4 levels fell outside the other cohort's reference range despite similar TSH levels. In clinical practice, thyroid testing of pregnant women without adding method specificity to gestational age-dependent reference ranges will compromise patient safety.
Type:
Journal article
Language:
English
Published in:
European Journal of Endocrinology, 2014, Vol 170, Issue 2, p. 329-339
Keywords:
Adult; Diagnostic Errors; Female; Fluoroimmunoassay; Gestational Age; Humans; Longitudinal Studies; Luminescent Measurements; Pregnancy; Prospective Studies; Reference Values; Reproducibility of Results; Thyroid Diseases; Thyroid Function Tests; Thyroid Gland; Thyrotropin; Thyroxine; Triiodothyronine; Comparative Study; Journal Article; Research Support, Non-U.S. Gov't
Main Research Area:
Medical science
Publication Status:
Published
Review type:
Peer Review
Submission year:
2014
Scientific Level:
Scientific
ID:
256935607

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