Direct Estimation of Reference Intervals for Thyroid Parameters in the Republic of Srpska
- PMID: 28680357
- PMCID: PMC5471646
- DOI: 10.1515/jomb-2017-0008
Direct Estimation of Reference Intervals for Thyroid Parameters in the Republic of Srpska
Abstract
Background: The aim of this study was to determine the reference values for thyrotropin (TSH), thyroid hormones (total and free thyroxine, T4 and fT4; total and free triiodothyronine, T3 and fT3), thyroglobulin (Tg) and thyroid antibodies (thyroid peroxidase, TPOAb and thyroglobulin antibody, TgAb) in the population of the Republic of Srpska.
Methods: A total of 250 euthyroid subjects were enrolled in this study. A direct method for choosing reference subjects was used to establish reference intervals. The hormones and thyroid antibodies were measured by an electrochemiluminescence immunoassay method (ECLIA, Roche Diagnostics, Mannheim, Germany). We calculated the reference intervals by MedCalc, version 12.1.4.0 (MedCalc software, Belgium) as recommended by the IFCC (CLSI C28-A3).
Results: Using guidelines recommended by the National Academy of Clinical Biochemistry (NACB) and based on standard statistical approaches, the reference intervals derived for TSH, fT4, T4, fT3, T3 were 0.75-5.32 mIU/L, 12.29-20.03 pmol/L, 73.49-126,30 nmol/L, 4.11-6.32 pmol/L, 1.15-2.32 nmol/L and for Tg, TPOAb, TgAb were 3.63-26.00 μg/L, <18.02 mIU/L, < 98.00 mIU/L, respectively. We found a significant difference (p<0.05) in TSH and fT3 values between different age groups as well as in T4, fT4 and fT3 values between ge nder groups.
Conclusions: The established reference values for the population of the Republic of Srpska were significantly different from the values recommended by the manufacturer of reagents (Roche Diagnostics). Our results showed that a laboratory needs to establish its own reference values in order to set up a proper diagnosis, as well as to treat patients successfully.
Uvod: Cilj ovog rada bio je da se utvrde referentne vrednosti tireotropnog hormona (TSH), tireoidnih hormona (ukupni tiroksin, T4 i slobodni tiroksin, fT4; ukupni trijodtironin, T3 i slobodni trijodtironin, fT3), tireoglobulina (Tg) i anti tela štitne žlezde (antitela na tireoperoksidazu, TPO-At i tireoglobulinska antitela, Tg-At) kod stanovništva Republike Srpske.
Metode: Ukupno 250 eutireoidnih ispitanika bilo je uključeno u ovo istraživanje. Korišćen je direktan način izbora referentnih osoba za utvrđivanje referentnog intervala. Hormoni i antitela štitne žlezde određivani su u serumu elektrohemiluminiscentnom metodom (ECLIA, Roche Diagnostics, Mannheim, Germany). Referentne granice su određene korištenjem programa MedCalc, verzija 12.1.4.0 (MedCalc software, Belgium) po preporuci IFCC (CLSI C28-A3).
Rezultati: Koristeći smernice Nacionalne akademije za kliničku biohemiju (NACB) i na temelju standardnih statistiČkih pristupa utvrđeni referentni intervali za TSH, fT4, T4, fT3, T3 bili su 0,75–5,32 mIU/L, 12,29–20,03 pmol/L, 73,49– 126,30 nmol/L, 4.11–6.32 pmol/L, 1,15–2,32 nmol/L kao i za Tg, TPOAt, TgAt 3, 63–26,00 μg/L, <18,02 mIU/L, < 98,00 mIU/L. Takođe, postojala je i značajna razlika između različitih starosnih grupa za TSH i fT3 vrednosti, kao i razlika za T4, fT4 i fT3 vrednosti između žena i muškaraca.
Zaključak: Dobijene referentne vrednosti za populaciju Republike Srpske znatno su se razlikovale od vrednosti preporučenih od strane proizvođača reagensa (Roche Diagnostics). Rezultati su ukazali da laboratorije moraju da izrade sopstvene referentne vrednosti sa ciljem postavljanja prave dijagnoze, kao i uspešnog lečenja pacijenata.
Keywords: TSH; reference values; thyroid hormones.
Conflict of interest statement
Conflict of interest statement: The authors stated that they have no conflicts of interest regarding the publication of this article.
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References
-
- Demers LM, Spencer CA.. Laboratory Medicine Practice guidelines: laboratory support for the diagnosis and monitoring of thyroid disease. Thyroid. 2003;13:3–126. - PubMed
-
- Prummel MF, Wiersinga WM.. Thyroid peroxidase autoantibodies in euthyroid subjects. Best Pract Res Clin Endo crinol Metab. 2005;19:1–5. - PubMed
-
- Hollowell JG, Staehling NW, Flanders WD, Hannon WH, Gunter EW, Spencer CA. et al. Serum TSH, T4, and thyroid antibodies in the United States population (1988 to 1994): National Health and Nutrition Examination Survey (NHANES III) J Clin Endocrinol Metab. 2002;87:489–99. - PubMed
-
- Dong YH, Fu DG.. Autoimmune thyroid disease: mechanism, genetics and current knowledge. Eur Rev Med Pharmacol Sci. 2014;18:3611–8. - PubMed
-
- Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory, Approved Guideline. ed 3. Villanova, PA: CLSI; 2008. Clinical Laboratory Standards Institute.
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