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Endocrinology and Metabolism |
1 Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, 2 Institute of Transfusion Medicines, and 3 Clinics for Nuclear Medicine, University Hospital Leipzig; Leipzig, Germany.
aAddress correspondence to this author at: Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, University Hospital Leipzig; Paul-List-Strasse 13-15, D-04103 Leipzig, Germany. Fax 49-341-9722249; e-mail kraj{at}medizin.uni-leipzig.de.
Background: The aim of our present study was to establish new reference intervals for thyrotropin (TSH) and thyroid hormones based on National Academy of Clinical Biochemistry (NACB) criteria and regular thyroid ultrasonography. We also assessed the effect of potentially confounding factors to modulate the limits of these intervals.
Methods: We investigated 870 apparently healthy persons and excluded, step by step, those with a family history of thyroid disease, pathologic thyroid ultrasonography results, and increased anti-thyroid peroxidase or anti-thyroglobulin antibodies. Accordingly, only 453 of the 870 persons in the entire group were finally included as reference collective. We measured serum concentrations of TSH, total and free thyroxine (T4 and FT4), and total and free triiodothyronine (T3 and FT3) of the whole and the reference collective on the ELECSYS system assays (Roche Diagnostics) and calculated the 2.5th and 97.5th percentiles for comparison.
Results: The calculated lower limit for TSH differed significantly between the reference intervals for healthy persons with an assessed normal thyroid gland vs the nonselected group of healthy blood donors. Age was the only independent factor and was significantly inversely associated with TSH (P <0.0001). Use of oral contracep-tives was a significant predictor for variation in T4 concentrations (P <0.001). Age and oral contraceptives were independently associated with T3 variations (P <0.05). For FT4 vs FT3 variation, gender and (inversely) age (P <0.01) were independent modulating factors.
Conclusions: The selection of healthy persons according to NACB criteria combined with sonographic confirmation of a normal thyroid gland provide a valid basis for the reference interval for TSH. Factors indicating a preclinical disease state, such as family history, pathologic ultrasonography result, or increased anti-thyroid peroxidase and anti-thyroglobulin antibodies, can be associated with normal hormone concentrations. Additionally, patient age and gender as well as use of contraceptives should be considered in diagnostic evaluation of thyroid diseases.
The following articles in journals at HighWire Press have cited this article:
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  T. E. Hamilton, S. Davis, L. Onstad, and K. J. Kopecky Thyrotropin Levels in a Population with No Clinical, Autoantibody, or Ultrasonographic Evidence of Thyroid Disease: Implications for the Diagnosis of Subclinical Hypothyroidism J. Clin. Endocrinol. Metab., April 1, 2008; 93(4): 1224 - 1230. [Abstract] [Full Text] [PDF]
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M. R. Haymart, D. J. Repplinger, G. E. Leverson, D. F. Elson, R. S. Sippel, J. C. Jaume, and H. Chen Higher Serum Thyroid Stimulating Hormone Level in Thyroid Nodule Patients Is Associated with Greater Risks of Differentiated Thyroid Cancer and Advanced Tumor Stage J. Clin. Endocrinol. Metab., March 1, 2008; 93(3): 809 - 814. [Abstract] [Full Text] [PDF]
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 B. Biondi and D. S. Cooper The Clinical Significance of Subclinical Thyroid Dysfunction Endocr. Rev., February 1, 2008; 29(1): 76 - 131. [Abstract] [Full Text] [PDF]
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M. I. Surks and J. G. Hollowell Age-Specific Distribution of Serum Thyrotropin and Antithyroid Antibodies in the U.S. Population: Implications for the Prevalence of Subclinical Hypothyroidism J. Clin. Endocrinol. Metab., December 1, 2007; 92(12): 4575 - 4582. [Abstract] [Full Text] [PDF]
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C. A. Spencer, J. G. Hollowell, M. Kazarosyan, and L. E. Braverman National Health and Nutrition Examination Survey III Thyroid-Stimulating Hormone (TSH)-Thyroperoxidase Antibody Relationships Demonstrate That TSH Upper Reference Limits May Be Skewed by Occult Thyroid Dysfunction J. Clin. Endocrinol. Metab., November 1, 2007; 92(11): 4236 - 4240. [Abstract] [Full Text] [PDF]
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 E. Jensen, O. Blaabjerg, P. H. Petersen, and L. Hegedus Sampling Time Is Important but May Be Overlooked in Establishment and Use of Thyroid-Stimulating Hormone Reference Intervals Clin. Chem., February 1, 2007; 53(2): 355 - 356. [Full Text] [PDF]
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 G Brabant, P Beck-Peccoz, B Jarzab, P Laurberg, J Orgiazzi, I Szabolcs, A P Weetman, and W M Wiersinga Is there a need to redefine the upper normal limit of TSH? Eur. J. Endocrinol., May 1, 2006; 154(5): 633 - 637. [Abstract] [Full Text] [PDF]
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K. Zophel, G. Wunderlich, and J. Kotzerke Should We Really Determine a Reference Population for the Definition of Thyroid-Stimulating Hormone Reference Interval? Clin. Chem., February 1, 2006; 52(2): 329 - 330. [Full Text] [PDF]
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D. Giavarina, R. M. Dorizzi, and G. Soffiati Indirect Methods for Reference Intervals Based on Current Data Clin. Chem., February 1, 2006; 52(2): 335 - 337. [Full Text] [PDF]
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E. Grossi, R. Colombo, S. Cavuto, and C. Franzini Indirect Methods for Reference Intervals Based on Current Data: The authors of the article cited above respond: Clin. Chem., February 1, 2006; 52(2): 337 - 338. [Full Text] [PDF]
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