Retrospective determination of reference intervals of thyroid-stimulating hormone for Russian population
https://doi.org/10.33667/2078-5631-2019-3-22(397)-71-77
Abstract
Among all hormonal studies, thyroid-stimulating hormone (TSH) remains the most often deviating from reference intervals (RI), despite the fact that the analytical characteristics of methods for assessing its concentration are improved from year to year, and the functional sensitivity of each subsequent generation is improved compared to the previous one. Currently, there is no consensus in the world community on the clinically justified limit of the upper TSH value for healthy people and, in fact, the current RI combines two ranges: the zone of almost ‘complete well-being’ (0.4–2.5 μMU/ml) and the one of latent pathology and/or ‘highly normal’ values (2.5–4.0 [5.0] μIU/ml). Considering the fact that each laboratory should determine the RI for measured analytes on the basis of the characteristics of the examined population, the characteristics of the used analytical systems, the achievement of the necessary diagnostic efficiency of the technique, its own practical and economic possibilities, the aim of this work was to retrospectively determine the TSH RI for the Russian population based on the analysis of 400 394 orders, including TSH, made during one year of observation. Consistent complication of exclusion criteria and calculation algorithms allowed to conditionally distinguish seven analyzed groups and stages of determining RI, based on the results of each of which intermediate and final results of the study were determined.
About the Authors
A. Yu. Olkhovik
Helix Laboratory Services
Russian Federation
Saint-Petersburg
Russian Federation
Saint-Petersburg
D. A. Pavlov
GIGA-Neurosciences, University of Liège, Liège, Belgium; Moscow State University n. a. M. V. Lomonosov
Russian Federation
Moscow
Russian Federation
Moscow
A. V. Vasilyev
Helix Laboratory Services
Russian Federation
Saint-Petersburg
Russian Federation
Saint-Petersburg
P. S. Sadovnikov
Helix Laboratory Services
Russian Federation
Saint-Petersburg
Russian Federation
Saint-Petersburg
V. L. Emanuel
First Saint Petersburg State Medical University n. a. I. P. Pavlov
Russian Federation
Saint Petersburg
Russian Federation
Saint Petersburg
References
1. Zimmermann M., Boelaert K. Iodine deficiency and thyroid disorders. The Lancet Diabetes & Endocrinology. 2015, 3 (4), 286–295. DOI: 10.1016/s2213–8587(14)70225–6.
2. Clinical and Laboratory Standards Institute (CLSI). Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory — Approved Guideline — Third Edition — CLSI Document EP28-A3c. (ISBN 1–56238–682–4) Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA, 19087–1898, USA, 2010.
3. Теряева Н. Б., Мошкин А. В. Граница референсного диапазона ТТГ: многолетняя дискуссия и возможности современной постаналитики. Клиническая лабораторная диагностика. 2016, 61 (11).
4. Jensen E., Hyltoft Petersen P., Blaabjerg O., Hansen P. S., Brix T. H., Hegeds L. Establishment of a serum thyroid stimulating hormone (TSH) reference interval in health adults. The importance of environmental factors, including thyroid antibodies. Clin Chem Lab Med. 2004; 42 (7): 824–832.
5. Zöphel K., Wunderlich G., Kotzerke J. Should we really determine a reference population for the definition of thyroid-stimulating hormone reference interval. Clin Chem. 2006; 52 (2): 329–330.
6. Fatourechi V. Editorial: upper limit of normal serum thyroid hormone: a moving and now an aging target? // Journal of Clinical Endocrinology & Metabolism. 2007; 92 (12): 4560–4562.
7. Farrell C., Nguyen L., Carter A. Data mining for age-related TSH reference intervals in adulthood. Clinical Chemistry And Laboratory Medicine (CCLM). 2017, 55 (10). DOI: 10.1515/cclm-2016–1123.
8. Surks M. I., Boucai L. Ageand race-based serum thyrotropin reference limits. J Clin Endocrinol Metab. 2010; 95(2): 496–502.
9. Hollowell J. G., Staehling N. W., Flanders W. D., Hannon W. H., Gunter E. W., Spencer C. A., Braverman LE. Serum TSH T(4), and thyroid antibodies in the United States population (1988–1994): National Health and Nutrition Examination Survey (NHANES III). J Clin Endocrinol Metab. 2002; 87: 489–99.
10. Kratzsch J., Fiedler G. M., Leichtle A., Brigel M., Buchbinder S., Otto L. et al. New reference intervals for thyrotropin and thyroid hormones based on National Academy of Clinical Biochemistry criteria and regular ultrasonography of the thyroid. Clin Chem. 2005; 51: 1480–1486.
11. Hamilton T. E., Davis S., Onstad L., Kopecky K. J. 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. 2008; 93: 1224–1230.
12. Völzke H., Alte D., Kohlmann T., L?demann J., Nauck M., John U., Meng W. Reference intervals of serum thyroid function tests in a previously iodine-defi cient area. Thyroid. 2005. 15: 279–85.
13. Baloch Z., Carayon P., Conte-Devoix B., Demers L. M., Feldt-Rasmussen U., Henry J. F. et al. Laboratory medicine practice guidelines: laboratory support for the diagnosis and monitoring of thyroid disease. Thyroid. 2003; 13: 3–126.
14. Baskin H. J., Cobin R. H., Duick D. S., Gharib H., Guttler R. B., Kaplan M. M., Segal R. L. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the evaluation and treatment of hyperthyroidism and hypothyroidism. Endocr Pract. 2002; 8 (6): 457–469.
15. А. В. Подзолков, В. В. Фадеев. Гипотиреоз, субклинический гипотиреоз, высоконормальный уровень ТТГ. Клиническая и экспериментальная тиреоидология. 2009, том 5, № 2.
16. Desirable Biological Variation Database specifications — Westgard. Retrieved from westgard.com/biodatabase1.htm.
17. ГОСТ Р 53133.2–2008 «Технологии лабораторные клинические. Контроль качества клинических лабораторных исследований. Часть 2. Правила проведения внутрилабораторного контроля качества количественных методов клинических лабораторных исследований с использованием контрольных материалов». [Ссылка активна на 16.04.2018]. Доступно по ссылке: docs.cntd.ru/document/1200072567 (11).
18. ГОСТ ISO 17511–2011 «Изделия медицинские для диагностики in vitro. Измерение величин в биологических пробах. Метрологическая прослеживаемость значений, приписанных калибраторам и контрольным материалам». [Ссылка активна на 16.04.2018]. Доступно по ссылке: docs.cntd.ru/document/1200098671 (12).
19. Grossi, E. The RELAB Project: a new method for the formulation of reference intervals based on current data. / E. Grossi, R. Colombo, S. Cavuta, C. Franzini // Clin Chem. 2005; 51: 1232–40. 10.1373/clinchem.2005.047787.
20. Фадеев В. В. Нормативы уровня ТТГ: нужны ли изменения. Клиническая тиреоидология. 2004, 2 (3): 5–9.
21. Подзолков А. В., Фадеев В. В. Гипотиреоз, субклинический гипотиреоз, высоконормальный уровень ТТГ. Клиническая и экспериментальная тиреодология. 2009; 5 (2): 4–16.
22. Spencer. Clinical implications of the new TSH reference range. AACC Expert Access. August 15, 2006. aacc.org/events/expert_access/2006/tshrange/pages/default.aspx.
23. Bhattacharya C. A simple method of resolution of a distribution into Gaussian components. / C. G. Bhattacharya // Biometrics. 1967; 23: 115–35. 10.2307/2528285.
24. Sarkar R. TSH comparison between chemiluminescence (Architect) and electrochemiluminescence (Cobas) immunoassays: an Indian population perspective. Indian journal of clinical biochemistry. 2014; 29 (2): 189–195.
Review
For citations:
Olkhovik A.Yu., Pavlov D.A., Vasilyev A.V., Sadovnikov P.S., Emanuel V.L. Retrospective determination of reference intervals of thyroid-stimulating hormone for Russian population. Medical alphabet. 2019;3(22):71-77. (In Russ.) https://doi.org/10.33667/2078-5631-2019-3-22(397)-71-77
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