Skip to content
Licensed Unlicensed Requires Authentication Published by De Gruyter July 13, 2021

The new Roche Elecsys TSH assay conforms with current IFCC C-STFT standards

  • Juergen Kratzsch , Nikola A. Baumann , Ferruccio Ceriotti ORCID logo , Zhong X. Lu , Matthias Schott , Antonius E. van Herwaarden , José Gilberto Henriques Vieira , Holger Lehmann , Dusanka Kasapic and Luca Giovanella ORCID logo EMAIL logo

Corresponding author: Prof. Dr. Med. Luca Giovanella, Clinic for Nuclear Medicine and Competence Centre for Thyroid Diseases, Ente Ospedaliero Cantonale, Via Athos Gallino 12, 6501, Bellinzona, Switzerland; and Clinic for Nuclear Medicine and Thyroid Centre, University Hospital, University of Zurich, Zurich, Switzerland, Phone: +41 918 118 672, Fax: +41 918 118 250, E-mail:

Funding source: Roche Diagnostics

Acknowledgments

The authors would like to thank Michael Rottmann of Roche Diagnostics for his help with the study design and data collection, and Martin Weiss of Roche Diagnostics for his assistance with data curation and analysis. Medical writing support was provided by Angela Corstorphine and Sian-Marie Lucas of Kstorfin Medical Communications Ltd, and Clair Clowes of inScience Communications, Springer Healthcare Ltd, and funded by Roche Diagnostics International Ltd. COBAS, COBAS E, and ELECSYS are trademarks of Roche. All other product names and trademarks are the property of their respective owners.

  1. Research funding: The study was funded by Roche Diagnostics International Ltd.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: All authors participated in an advisory board for Roche Diagnostics. J.G.H.V. holds stocks in Group Fleury. J.K. has received grants for presentations from Roche and Novartis and a research grant from PES. L.G. has received research grants from Roche Diagnostics, speaker honoraria from Roche Diagnostics, Brahms GmbH, Eisai, Siemens Healthcare and Sanofi-Genzyme, and serves on an advisory board for Roche Diagnostics. N.A.B. has received an honorarium for serving on an advisory board for Roche Diagnostics. M.S. has received an honorarium from Roche for an oral presentation. A.E.V.H has received an honorarium to his institution for serving on an advisory board for Roche Diagnostics. H.L. and D.K. and are employees of Roche Diagnostics. No further competing financial interests exist for F.C. and Z.X.L.

  4. Informed consent: The study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. Written informed patient consent was received for all sample collections in the method comparison study.

  5. Ethical approval: Bioethics Committee approval was received for all sample collections in the method comparison study. Data for the lot-to-lot consistency study were anonymized and collected according to data safety regulations.

References

1. Schneider, C, Feller, M, Bauer, DC, Collet, TH, da Costa, BR, Auer, R, et al.. Initial evaluation of thyroid dysfunction – are simultaneous TSH and fT4 tests necessary? PloS One 2018;13:e0196631. https://doi.org/10.1371/journal.pone.0196631.Search in Google Scholar

2. Thienpont, LM, Van Uytfanghe, K, Beastall, G, Faix, JD, Ieiri, T, Miller, WG, et al.. Report of the IFCC working Group for standardization of thyroid function tests; part 1: thyroid-stimulating hormone. Clin Chem 2010;56:902–11. https://doi.org/10.1373/clinchem.2009.140178.Search in Google Scholar

3. Beckett, G, MacKenzie, F. Thyroid guidelines – are thyroid-stimulating hormone assays fit for purpose? Ann Clin Biochem 2007;44:203–8. https://doi.org/10.1258/000456307780480945.Search in Google Scholar

4. Rawlins, ML, Roberts, WL. Performance characteristics of six third-generation assays for thyroid-stimulating hormone. Clin Chem 2004;50:2338–44. https://doi.org/10.1373/clinchem.2004.039156.Search in Google Scholar

5. Owen, WE, Gantzer, ML, Lyons, JM, Rockwood, AL, Roberts, WL. Functional sensitivity of seven automated thyroid stimulating hormone immunoassays. Clin Chim Acta 2011;412:2336–9. https://doi.org/10.1016/j.cca.2011.08.002.Search in Google Scholar

6. Barth, JH, Luvai, A, Jassam, N, Mbagaya, W, Kilpatrick, ES, Narayanan, D, et al.. Comparison of method-related reference intervals for thyroid hormones: studies from a prospective reference population and a literature review. Ann Clin Biochem 2018;55:107–12. https://doi.org/10.1177/0004563217691549.Search in Google Scholar

7. Gaines Das, RE, Bristow, AF. The second international reference preparation of thyroid-stimulating hormone, human, for immunoassay: calibration by bioassay and immunoassay in an international collaborative study. J Endocrinol 1985;104:367–79. https://doi.org/10.1677/joe.0.1040367.Search in Google Scholar

8. Thienpont, LM, Van Uytfanghe, K, Van Houcke, S, Das, B, Faix, JD, MacKenzie, F, et al.. A progress report of the IFCC committee for standardization of thyroid function tests. Eur Thyroid J 2014;3:109–16. https://doi.org/10.1159/000358270.Search in Google Scholar

9. Thienpont, LM, Van Uytfanghe, K, De Grande, LAC, Reynders, D, Das, B, Faix, JD, et al.. Harmonization of serum thyroid-stimulating hormone measurements paves the way for the adoption of a more uniform reference interval. Clin Chem 2017;63:1248–60. https://doi.org/10.1373/clinchem.2016.269456.Search in Google Scholar

10. Passing, H, Bablok. A new biometrical procedure for testing the equality of measurements from two different analytical methods. Application of linear regression procedures for method comparison studies in clinical chemistry, Part I. J Clin Chem Clin Biochem 1983;21:709–20. https://doi.org/10.1515/cclm.1983.21.11.709.Search in Google Scholar

11. Bland, JM, Altman, DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986;1:307–10. https://doi.org/10.1016/s0140-6736(86)90837-8.Search in Google Scholar

12. CLSI. Defining, establishing, and verifying reference intervals in the clinical laboratory – CLSI document EP28-A3C:2010, 3rd ed. Wayne, Pennsylvania: CLSI – Clinical and Laboratory Standards Institute; 2010.Search in Google Scholar

13. Lee, GR, Griffin, A, Halton, K, Fitzgibbon, MC. Generating method-specific Reference Ranges – a harmonious outcome? Pract Lab Med 2017;9:1–11. https://doi.org/10.1016/j.plabm.2017.06.001.Search in Google Scholar


Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2021-0352).


Received: 2021-03-23
Accepted: 2021-06-29
Published Online: 2021-07-13
Published in Print: 2021-11-25

© 2021 Walter de Gruyter GmbH, Berlin/Boston

Downloaded on 18.4.2024 from https://www.degruyter.com/document/doi/10.1515/cclm-2021-0352/html
Scroll to top button