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Direct versus indirect strategies for thyroid hormone reference intervals established in a middle-aged and elderly population on an immunoassay analyzer

Year 2010, , 161 - 167, 01.09.2010
https://doi.org/10.5799/ahinjs.01.2010.03.0034

Abstract

Objectives: Establishment of reference values by direct strategy for selection of reference individuals is time-consuming and expensive for laboratories. The aim of this study was to establish reference intervals for thyrotrophin(TSH), free thyroxine (FT4), free triiodothyronine (FT3) in a middle-aged and elderly population (age range; 40-80 years) on an immunoassay analyzer using both direct and indirect strategies, and to compare the results of direct and indirect strategies. Materials and methods: As for direct sampling strategy, healthy reference individuals were randomly selected (129 male, 131 female; age range: 40-80) by questionnaire. As for indirect sampling strategy, the results of TSH, FT3, FT4 measurements of all individuals (male, n=3060-3920; female, n=4090-4520; age range 40-80 years), were selected from laboratory information system. Reference intervals were calculated by nonparametric methods Results: The following 95% reference intervals were determined: For direct sampling group: TSH 0.32-4.38 µIU/mL; FT4 0.75-1.32 ng/dL; FT3 1.98-3.65 pg/mL. For indirect sampling group: TSH 0.29-4.36 µIU/mL; FT4 0.71-1.37 ng/dL; FT3 1.69-3.32 pg/mL. Indirect sampling group showed a good concordance in the reference intervals for TSH and FT4 with direct sampling group. Conclusion: Indirect sampling strategy and nonparametric method may be confidently used to evaluate the reference intervals of serum TSH and FT4 on an analyzer. We suggested the utilization of a very simple and practical way, indirect sampling strategy, for evaluating reference intervals for elderly population.

References

  • Solberg HE. The IFCC recommendation on estimation of refernce intervals. The Referral Program. Clin Chem Lab Med 2004;42:710-4.
  • Gonzales-Sagrado M, Martin-Gil FJ. Population-specific ref- erence values for thyroid hormones on the Abbott ARCHI- TECT i2000 analyzer. Clin Chem Lab Med. 2004;42:540-2.
  • Burtis CA, Ashwood ER, Bruns DE. Establishment and use of reference values.In: Solberg HE. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, fourth ed. Elsevier Saunders, 2005:425-448.
  • International Federation of Clinical Chemistry, Expert Panel on Theory of Reference Values.. Approved recommendation on the theory of reference values. Part 1. The concept of ref- erence values. J Clin Chem Clin Biochem 1987;25:337-42.
  • International Federation of Clinical Chemistry, Expert Panel on Theory of Reference Values. Approved recommendation on the theory of reference values. Part 2. Selection of indi- viduals for the production of reference values. J Clin Chem Clin Biochem. 1987;25:639-44.
  • Solberg HE. International Federation of Clinical Chemistry, Expert Panel on Theory of Reference Values, and Internation- al Committee for standardization in Haematology, Standing Committee for reference values. Approved recommendation on the theory of reference values. Part 5.Statistical treatment of collected reference values. J Clin Chem Clin Biochem 1987; 25:645-56.
  • Kratzsch J, Fiedler GM, Leichtle A, et al. New reference inter- vals for thyrotropin and thyroid hormones based on National Academy of Clinical Biochemistry criteria and regular ultra- sonography of the thyroid. Clin Che. 2005;51:1480-86.
  • Grasbeck R, Alström T. Reference values in laboratory medi- cine. The current state of the art. Chichester, England: John Wiley, 1981.
  • Baadenhuijsen H, Smit JC. Indirect estimation of clinical chemical reference intervals from total hospital patient data: Application of a modified Bhattacharya procedure. J Clin Chem Clin Biochem 1985;23:829-39.
  • Hubl W, Schmieder J, Gladrow E, Demant T. Reference in- tervals for thyroid hormones on the Architect analyzer. Clin Chem Lab Med 2002;40:165-6.
  • Dhatt GS, Griffin G, Agarwal MM. Thyroid hormone refer- ence intervals in an ambulatory Arab population on the Ab- bott Architect i2000 immunoassay analyzer. Clin Chim Acta 2006; 364:226-9.
  • Zöphel K, Wunderlich G, Kotzerke J. Should we really determine a reference population for the definition of thy- roid-stimulating hormone reference interval? Clin Chem 2006;52:329-30.
  • Hershman JM, Pekary AE, Berg L, Solomon DH, Sawin CT. Serum thyrotropin and thyroid hormone levels in el- derly and middle-aged euthyroid persons. J Am Geriatr Soc 1993;41:823-8.
  • Hoogendoorn EH, Hermus AR, Vegt FD, et al. Thyroid func- tion and prevalance of anti-thyroperoxidase antibodies in a population with borderline sufficient iodine intake: Influ- ences of age and sex. Clin Chem 2006;52:104-11.
  • National Committee for Clinical Laboratory Standards. How to define and determine reference intervals in the clinical lab- oratory; approved guideline, 2nd ed.Villanova, PA. NCCLS; 2000. NCCLS Document C28-A2 (ISBN 1-56238-406-6)
  • Enli Y, Aslan D, Akalın N, et al. Determination of Reference intervals for 18-40 years old people living in Denizli by us- ing different methods. Turk J Biochem 2003; 28;228-45.
  • Reed AH, Henry JR, Mason WB. Influence of statistical method used on the resulting estimate of normal range. Clin Chem 1971;17:275-84.
  • Davey R. Thyroxine, thyrotropin, and age in euthyroid hospi- tal patient population. Clin Chem 1997;43:2143-8.
  • d’Herbomez M, Forzy G, Gasser F, Massart C, Beaudonnet A, Sapin R. Clinical evaluation of nine free thyroxine assays: persistent problems in particular populations. Clin Chem Lab Med 2003;41:942-7.
  • Ilcol Y, Aslan D. Determining reference value of blood chem- istry profile in healthy subjects in Bursa. Turk J Biochem 2004;29:183-92.
  • National Committee for Clinical Laboratory Standards. How to define and determine reference intervals in the clinical laboratory; proposed guideline. 1995. NCCLS Document C28-A. Villanova, PA. NCCLS.
  • Ilcol YO, Aslan D. Use of total patient data for indirect es- timation of reference intervals for 40 clinical chemical ana- lytes in Turkey. Clin Chem Lab Med 2006;44:867–76.

Direct versus indirect strategies for thyroid hormone reference intervals established in a middle-aged and elderly population on an immunoassay analyzer

Year 2010, , 161 - 167, 01.09.2010
https://doi.org/10.5799/ahinjs.01.2010.03.0034

Abstract

Amaç: Referans bireylerden direkt yöntemle referans değerleri belirlemek her laboratuvar için hem zaman alıcı hem de maliyetli olmaktadır. Bu çalışmanın amacı, orta ve yaşlı populasyonun (yaş aralığı; 40-80 yaş) tirotropin (TSH), serbest tiroksin (ST4), serbest triiyodotironin (ST3) değerleri için Abbott Architect i2000 immunoassay analizöründe referans aralıklarını belirlemek ve indirekt ve direkt yöntem sonuçlarını birbiriyle karşılaştırmak. Yöntem: Direkt yöntem için referans bireyler (129 erkek, 131 kadın; yaş aralığı: 40-80) anket formuyla seçildi. İndirekt yöntem için TSH, ST4, ST3 ölçüm sonuçları laboratuar bilgi sisteminden [erkek n=(3060-3920), kadın n=(4090-4520) yaş aralığı:40-80 yıl] elde edildi. Referans aralıklar nonparametrik metod ile hesaplandı. Bulgular: %95 merkezi alan temel alınarak referans aralıkları belirlendi. Direkt yöntem grubunda; TSH, 0.32-4.38 µIU/mL; ST4, 0.75-1.32 ng/dL; ST3, 1.98-3.65 pg/mL idi. İndirekt yöntem grubunda; TSH, 0.29-4.36 µIU/mL; ST4, 0.71-1.37 ng/dL; ST3, 1.69-3.32 pg/mL idi. İndirekt yöntem grubu TSH ve ST4 için direkt yöntem grubuyla çok iyi bir uyum gösterdi. Sonuç: İndirekt yöntem ve nonparametrik metod Abbott Architect i2000 analizöründe TSH ve FT4 referans aralıkları belirlemede güvenli olarak kullanılabilir. Biz ilgilenilen bölgesel populasyonun referans aralıklarını belirlemek için indirekt yöntemle basit ve pratik bir yol öneriyoruz.

References

  • Solberg HE. The IFCC recommendation on estimation of refernce intervals. The Referral Program. Clin Chem Lab Med 2004;42:710-4.
  • Gonzales-Sagrado M, Martin-Gil FJ. Population-specific ref- erence values for thyroid hormones on the Abbott ARCHI- TECT i2000 analyzer. Clin Chem Lab Med. 2004;42:540-2.
  • Burtis CA, Ashwood ER, Bruns DE. Establishment and use of reference values.In: Solberg HE. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, fourth ed. Elsevier Saunders, 2005:425-448.
  • International Federation of Clinical Chemistry, Expert Panel on Theory of Reference Values.. Approved recommendation on the theory of reference values. Part 1. The concept of ref- erence values. J Clin Chem Clin Biochem 1987;25:337-42.
  • International Federation of Clinical Chemistry, Expert Panel on Theory of Reference Values. Approved recommendation on the theory of reference values. Part 2. Selection of indi- viduals for the production of reference values. J Clin Chem Clin Biochem. 1987;25:639-44.
  • Solberg HE. International Federation of Clinical Chemistry, Expert Panel on Theory of Reference Values, and Internation- al Committee for standardization in Haematology, Standing Committee for reference values. Approved recommendation on the theory of reference values. Part 5.Statistical treatment of collected reference values. J Clin Chem Clin Biochem 1987; 25:645-56.
  • Kratzsch J, Fiedler GM, Leichtle A, et al. New reference inter- vals for thyrotropin and thyroid hormones based on National Academy of Clinical Biochemistry criteria and regular ultra- sonography of the thyroid. Clin Che. 2005;51:1480-86.
  • Grasbeck R, Alström T. Reference values in laboratory medi- cine. The current state of the art. Chichester, England: John Wiley, 1981.
  • Baadenhuijsen H, Smit JC. Indirect estimation of clinical chemical reference intervals from total hospital patient data: Application of a modified Bhattacharya procedure. J Clin Chem Clin Biochem 1985;23:829-39.
  • Hubl W, Schmieder J, Gladrow E, Demant T. Reference in- tervals for thyroid hormones on the Architect analyzer. Clin Chem Lab Med 2002;40:165-6.
  • Dhatt GS, Griffin G, Agarwal MM. Thyroid hormone refer- ence intervals in an ambulatory Arab population on the Ab- bott Architect i2000 immunoassay analyzer. Clin Chim Acta 2006; 364:226-9.
  • Zöphel K, Wunderlich G, Kotzerke J. Should we really determine a reference population for the definition of thy- roid-stimulating hormone reference interval? Clin Chem 2006;52:329-30.
  • Hershman JM, Pekary AE, Berg L, Solomon DH, Sawin CT. Serum thyrotropin and thyroid hormone levels in el- derly and middle-aged euthyroid persons. J Am Geriatr Soc 1993;41:823-8.
  • Hoogendoorn EH, Hermus AR, Vegt FD, et al. Thyroid func- tion and prevalance of anti-thyroperoxidase antibodies in a population with borderline sufficient iodine intake: Influ- ences of age and sex. Clin Chem 2006;52:104-11.
  • National Committee for Clinical Laboratory Standards. How to define and determine reference intervals in the clinical lab- oratory; approved guideline, 2nd ed.Villanova, PA. NCCLS; 2000. NCCLS Document C28-A2 (ISBN 1-56238-406-6)
  • Enli Y, Aslan D, Akalın N, et al. Determination of Reference intervals for 18-40 years old people living in Denizli by us- ing different methods. Turk J Biochem 2003; 28;228-45.
  • Reed AH, Henry JR, Mason WB. Influence of statistical method used on the resulting estimate of normal range. Clin Chem 1971;17:275-84.
  • Davey R. Thyroxine, thyrotropin, and age in euthyroid hospi- tal patient population. Clin Chem 1997;43:2143-8.
  • d’Herbomez M, Forzy G, Gasser F, Massart C, Beaudonnet A, Sapin R. Clinical evaluation of nine free thyroxine assays: persistent problems in particular populations. Clin Chem Lab Med 2003;41:942-7.
  • Ilcol Y, Aslan D. Determining reference value of blood chem- istry profile in healthy subjects in Bursa. Turk J Biochem 2004;29:183-92.
  • National Committee for Clinical Laboratory Standards. How to define and determine reference intervals in the clinical laboratory; proposed guideline. 1995. NCCLS Document C28-A. Villanova, PA. NCCLS.
  • Ilcol YO, Aslan D. Use of total patient data for indirect es- timation of reference intervals for 40 clinical chemical ana- lytes in Turkey. Clin Chem Lab Med 2006;44:867–76.
There are 22 citations in total.

Details

Primary Language Turkish
Journal Section Research Article
Authors

Sedat Motor This is me

Gönül Erden This is me

Birsen Sahillioğlu This is me

Serpil Erdoğan This is me

Mustafa Metin Yıldırımkaya This is me

Publication Date September 1, 2010
Published in Issue Year 2010

Cite

APA Motor, S., Erden, G., Sahillioğlu, B., Erdoğan, S., et al. (2010). Direct versus indirect strategies for thyroid hormone reference intervals established in a middle-aged and elderly population on an immunoassay analyzer. Journal of Clinical and Experimental Investigations, 1(3), 161-167. https://doi.org/10.5799/ahinjs.01.2010.03.0034
AMA Motor S, Erden G, Sahillioğlu B, Erdoğan S, Yıldırımkaya MM. Direct versus indirect strategies for thyroid hormone reference intervals established in a middle-aged and elderly population on an immunoassay analyzer. J Clin Exp Invest. September 2010;1(3):161-167. doi:10.5799/ahinjs.01.2010.03.0034
Chicago Motor, Sedat, Gönül Erden, Birsen Sahillioğlu, Serpil Erdoğan, and Mustafa Metin Yıldırımkaya. “Direct Versus Indirect Strategies for Thyroid Hormone Reference Intervals Established in a Middle-Aged and Elderly Population on an Immunoassay Analyzer”. Journal of Clinical and Experimental Investigations 1, no. 3 (September 2010): 161-67. https://doi.org/10.5799/ahinjs.01.2010.03.0034.
EndNote Motor S, Erden G, Sahillioğlu B, Erdoğan S, Yıldırımkaya MM (September 1, 2010) Direct versus indirect strategies for thyroid hormone reference intervals established in a middle-aged and elderly population on an immunoassay analyzer. Journal of Clinical and Experimental Investigations 1 3 161–167.
IEEE S. Motor, G. Erden, B. Sahillioğlu, S. Erdoğan, and M. M. Yıldırımkaya, “Direct versus indirect strategies for thyroid hormone reference intervals established in a middle-aged and elderly population on an immunoassay analyzer”, J Clin Exp Invest, vol. 1, no. 3, pp. 161–167, 2010, doi: 10.5799/ahinjs.01.2010.03.0034.
ISNAD Motor, Sedat et al. “Direct Versus Indirect Strategies for Thyroid Hormone Reference Intervals Established in a Middle-Aged and Elderly Population on an Immunoassay Analyzer”. Journal of Clinical and Experimental Investigations 1/3 (September 2010), 161-167. https://doi.org/10.5799/ahinjs.01.2010.03.0034.
JAMA Motor S, Erden G, Sahillioğlu B, Erdoğan S, Yıldırımkaya MM. Direct versus indirect strategies for thyroid hormone reference intervals established in a middle-aged and elderly population on an immunoassay analyzer. J Clin Exp Invest. 2010;1:161–167.
MLA Motor, Sedat et al. “Direct Versus Indirect Strategies for Thyroid Hormone Reference Intervals Established in a Middle-Aged and Elderly Population on an Immunoassay Analyzer”. Journal of Clinical and Experimental Investigations, vol. 1, no. 3, 2010, pp. 161-7, doi:10.5799/ahinjs.01.2010.03.0034.
Vancouver Motor S, Erden G, Sahillioğlu B, Erdoğan S, Yıldırımkaya MM. Direct versus indirect strategies for thyroid hormone reference intervals established in a middle-aged and elderly population on an immunoassay analyzer. J Clin Exp Invest. 2010;1(3):161-7.