Verification of the reference range for examination of thyroid parameters (TSH, fT3 a fT4) on the analyzer DxI 800 from Beckman Coulter
Authors:
S. Vaingátová 1,2; J. Franeková 1,2; A. Jabor 1,2
Authors‘ workplace:
Oddělení klinické biochemie, Pracoviště laboratorních metod, Institut klinické a experimentální medicíny, Praha
1; 3. lékařská fakulta UK, Praha
2
Published in:
Klin. Biochem. Metab., 27, 2019, No. 1, p. 4-8
Overview
Objective: Verification of the reference ranges given by the manufacturer for the determination of thyrotropin (TSH), free triiodothyronine (fT3), and free thyroxine (fT4) by immunoanalytical methods on a Beckman Coulter DxI 800 analyzer.
Design: Original Article.
Settings: Institute for Clinical and Experimental Medicine, Vídeňská 1958/9, 140 21 Praha 4
Materials and methods: A total of 110 samples of healthy volunteer sera (55 men and 55 women) were measured to verify the reference interval for Beckman Coulter’s Access TSH (3rd IS), Access Free T3, and Access Free T4 methods. To exclude an unmanifested thyroid disease, proband sera were tested for the presence of thyroid peroxidase antibodies by the Access TPO Antibody method (Beckman Coulter). The resulting values were statistically evaluated using the robust CLSI C28-A3 method and the Box-Cox transformation in the MedCalc Statistical Software version 17.2.
Results: For the TSH method, a reference interval of 0.67 - 4.31 mIU/l (company figures 0.38 - 5.33 mIU/l) was established, for the fT3 method 4.99 - 7.49 pmol/l (company figures 3.8 - 6.0 pmol/l) and for the fT4 method 7.46 - 13.04 pmol/l (company figures 7.86 - 14.41 pmol/l).
Conclusion: The reference interval specified for the TSH method by the reagents´ manufacturer can be considered as verified and valid. The reference interval we determined for the fT3 method does not match the reference interval recommended by the manufacturer - we found higher values for both the lower and upper reference limits. We would recommend adjusting this interval according to the measured data prior to routine implementation. As for the fT4 determination method, we would suggest to shift the recommended reference interval towards lower values.
Keywords:
TSH – fT3 – fT4 – DxI 800 – reference interval (RI)
Sources
1. Thienpont, L. M., Faix, J. D., Beastall, G. Standardization of Free thyroxine and Harmonization of Thyrotropin Measurements: A Request for Input from Endocrinologist and Other Physicians. Thyroid, 2015, 25(12), p. 1379-80
2. Beckman Coulter Inc., Návod k použití B77706 B - Příbalový leták k metodě Access TSH (3 rd IS), česká verze, prosinec 2015, 13 s.
3. Beckman Coulter Inc., Návod k použití A33730 H - Příbalový leták k metodě Access Free T3, česká verze, prosinec 2016, 13 s.
4. Beckman Coulter Inc., Návod k použití B01902 D - Příbalový leták k metodě Access Free T4, česká verze, prosinec 2015, 12 s.
5. Beckman Coulter Inc., Návod k použití B77707 B - Příbalový leták ke kalibrátoru Access TSH (3rd IS), česká verze, prosinec 2015, 5 s.
6. Beckman Coulter Inc., Návod k použití B50142 C - Příbalový leták ke kalibrátoru Access Free T3, česká verze, prosinec 2016, 4 s.
7. Beckman Coulter Inc. Návod k použití B50143 C - Příbalový leták ke kalibrátoru Access Free T4, česká verze, leden 2016, 5 s.
8. Beckman Coulter Inc., Návod k použití A83813 D - Příbalový leták k metodě Access TPO Antibody, česká verze, prosinec 2015, 11 s.
9. MedCalc Statistical Software version 17.2, MedCalc Software bvba, Ostend, Belgium; http://www.medcalc.org; 2017
10. Límanová, Z., Pikner, R., Springer, D. Doporučení pro laboratorní diagnostiku funkčních a autoimunitních onemocnění štítné žlázy. Klin. Biochem. Metab., 2011, 19(40), č. 1, p. 48–61
11. Thienpont L.M., Van Uytfanghe, K., Beastall, G. et al. Report of the IFCC Working Group for Standardization of Thyroid Function Tests; Part 2: Free Thyroxine and Free Triiodothyronine. Clin. Chem., 2010, 56(6): p. 912-920
12. Van Houcke, S.K., Van Uytfanghe, K., Shimizu, E., Tani, W., Umemoto, M., Thienpont, L.M. IFCC international conventional reference procedure for the measurement of free thyroxine in serum. International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group for Standardization of Thyroid Function Tests (WG-STFT). Clin. Chem. Lab. Med., 2011 49(8), p. 1275-81
13. De Grande, L.A.C., Van Uytfanghe, K., Reynders, D. et al. Standardization of Free Thyroxine Measurements Allows the Adoption of a More Uniform Reference Interval. Clin. Chem., 2017, 63(10), p. 1642-52
14. Thienpont, L.M., Van Uytfanghe, K., De Grande, L.A.C. et al. Harmonization of Serum Thyroid-Stimulating Hormone Measurements Paves the Way for the Adoption of a More Uniform Reference Interval. Clin. Chem., 2017, 63(7), p. 1248-1260
15. Thomas L. Clinical Laboratory Diagnostics: Use and Assessment of Clinical Laboratory Results. Frankfurt/Main: TH-Books, 1. vydání, 1998, 1527 s. ISBN 3-9805215-4-0.
16. Röcker, L., Janiszewski, Ch., Hopfenmüller, W. Determination of reference ranges for thyroid hormones in serum for the population of Berlin (West) with special emphasis of age- and gender- dependence. Lab. Med., 1988, 12, p. 213-22
17. Liappis, N., v Bernstorff, W., Schlebusch H. Refe-rence values for the concentration of free triiodothyronine, triiodothyronine, free thyroxine, thyroxine, thyrotropin and thyroxin-binding globulin in serum of euthyroid adults. Influence of oral contraceptives. Method: luminiscence-enhanced enzyme immunoassay. Ärztl Lab, 1990, 36, p. 8-11
18. Mrázová, K. et al. Referenční hodnoty laboratorních vyšetření. In Zima, T. et al. Laboratorní diagnostika, Praha: Galén, 2013, s. 1100-1101
19. Kratzsch, J., Fiedler, G.M., Leichtle, A. 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(8), p.1480-86
20. Cyklus EHK E11/18 – Endokrinologie 1, Souhrnná statistika – kvantitativní výsledky, SEKK s r.o., březen 2018, 11 s.
Labels
Clinical biochemistry Nuclear medicine Nutritive therapistArticle was published in
Clinical Biochemistry and Metabolism
2019 Issue 1
Most read in this issue
- Measurement uncertainty and error in medical laboratories
- Diabetes mellitus – laboratorní diagnostika a sledování stavu pacientů
- Utilization of Prostate Health Index in prediction of prostate cancer aggressiveness
- Verification of the reference range for examination of thyroid parameters (TSH, fT3 a fT4) on the analyzer DxI 800 from Beckman Coulter