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Licensed Unlicensed Requires Authentication Published by De Gruyter April 25, 2022

Evaluation of the AFIAS-1 thyroid-stimulating hormone point of care test and comparison with laboratory-based devices

Sascha Dierks, Reiner Andag, Friederike Gauss, Kathrin Budde, Paul Francke, Manuela Peschka, Andreas Fischer, Julie Schanz and Astrid Petersmann

Abstract

Objectives

Thyroid-stimulating hormone (TSH) is the routine primary screening test to assess thyroid function and rapid measurement of TSH levels is highly desirable especially in emergency situations. In the present study, we compared the analytical performance of a commercially available point-of-care test (AFIAS-1) and five laboratory-based systems.

Methods

Left over material of 60 patient plasma samples was collected from patient care and used in the respective assay. For statistical analysis of the produced data Bland-Altman and Passing-Bablok regression analysis were applied.

Results

Good correlation (r=0.982 or higher) was found between all devices. Slopes from regression analysis ranged from 0.972 (95% CI: 0.927–1.013) to 1.276 (95% CI: 1.210–1.315). Among the compared devices, imprecision was high in terms of coefficient of variation (CV=10.3%) for low TSH concentrations and lower (CV=7.3%) for high TSH concentrations. Independent of the method used, we demonstrated a poor standardization of TSH assays, which might impact clinical diagnosis e.g. of hyperthyreosis.

Conclusions

This study shows that the point-of-care (POC) test AFIAS-1 can serve as an alternative to laboratory-based assays. In addition the data imply that better standardization of TSH measurements is needed.


Corresponding author: Sascha Dierks, Institute of Clinical Chemistry, University Medical Center Göttingen, Göttingen, Germany, Phone: +49 551 39 65698, E-mail:

  1. Research funding: This study was partly funded by nal von minden GmbH (Goettingen, Germany).

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

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Informed consent was obtained from all individuals included in this study.

  5. Ethical approval: Research involving human subjects complied with all relevant national regulations, institutional policies and is in accordance with the tenets of the Helsinki Declaration (as revised in 2013), and has been approved by the authors’ Institutional Review Board (No.: 24/11/21).

  6. Data availability: The dataset is available in the Supplementary Material.

References

1. Rose, SR, Brown, RS, Foley, T, Kaplowitz, PB, Kaye, CI, Sundararajan, S, et al.. Update of newborn screening and therapy for congenital hypothyroidism. Pediatrics 2006;117:2290–303. https://doi.org/10.1542/peds.2006-0915.Search in Google Scholar PubMed

2. Santos de los, ET, Starich, GH, Mazzaferri, EL. Sensitivity, specificity, and cost-effectiveness of the sensitive thyrotropin assay in the diagnosis of thyroid disease in ambulatory patients. Arch Intern Med 1989;149:526–32.10.1001/archinte.1989.00390030032006Search in Google Scholar

3. Ross, DS, Burch, HB, Cooper, DS, Greenlee, MC, Laurberg, P, Maia, AL, et al.. American thyroid association guidelines for diagnosis and management of hyperthyroidism and other causes of thyrotoxicosis. Thyroid 2016;26:1343–421. https://doi.org/10.1089/thy.2016.0229.Search in Google Scholar PubMed

4. Rhee, CM, Bhan, I, Alexander, EK, Brunelli, SM. Association between iodinated contrast media exposure and incident hyperthyroidism and hypothyroidism. Arch Intern Med 2012;172:153–9. https://doi.org/10.1001/archinternmed.2011.677.Search in Google Scholar PubMed

5. Lee, SY, Rhee, CM, Leung, AM, Braverman, LE, Brent, GA, Pearce, EN. A review: radiographic iodinated contrast media-induced thyroid dysfunction. J Clin Endocrinol Metab 2015;100:376–83. https://doi.org/10.1210/jc.2014-3292.Search in Google Scholar PubMed PubMed Central

6. Dunne, P, Kaimal, N, MacDonald, J, Syed, AA. Iodinated contrast-induced thyrotoxicosis. CMAJ (Can Med Assoc J) 2013;185:144–7. https://doi.org/10.1503/cmaj.120734.Search in Google Scholar PubMed PubMed Central

7. Andreucci, M, Solomon, R, Tasanarong, A. Side effects of radiographic contrast media: pathogenesis, risk factors, and prevention. BioMed Res Int 2014;2014:741018. https://doi.org/10.1155/2014/741018.Search in Google Scholar PubMed PubMed Central

8. Völzke, H, Lüdemann, J, Robinson, DM, Spieker, KW, Schwahn, C, Kramer, A, et al.. The prevalence of undiagnosed thyroid disorders in a previously iodine-deficient area. Thyroid 2003;13:803–10.10.1089/105072503768499680Search in Google Scholar PubMed

9. Soh, SB, Aw, TC. Laboratory testing in thyroid conditions – pitfalls and clinical utility. Ann Lab Med 2019;39:3–14. https://doi.org/10.3343/alm.2019.39.1.3.Search in Google Scholar PubMed PubMed Central

10. Spencer, CA, Hollowell, JG, Kazarosyan, M, Braverman, LE. National Health and Nutrition Examination Survey III thyroid-stimulating hormone (TSH)-thyroperoxidase antibody relationships demonstrate that TSH upper reference limits may be skewed by occult thyroid dysfunction. J Clin Endocrinol Metab 2007;92:4236–40. https://doi.org/10.1210/jc.2007-0287.Search in Google Scholar PubMed

11. Brabant, G, Beck-Peccoz, P, Jarzab, B, Laurberg, P, Orgiazzi, J, Szabolcs, I, et al.. Is there a need to redefine the upper normal limit of TSH? Eur J Endocrinol 2006;154:633–7. https://doi.org/10.1530/eje.1.02136.Search in Google Scholar

12. Biondi, B. The normal TSH reference range: what has changed in the last decade? J Clin Endocrinol Metab 2013;98:3584–7. https://doi.org/10.1210/jc.2013-2760.Search in Google Scholar

13. Langén, VL, Niiranen, TJ, Mäki, J, Sundvall, J, Jula, AM. Thyroid-stimulating hormone reference range and factors affecting it in a nationwide random sample. Clin Chem Lab Med 2014;52:1807–13.10.1515/cclm-2014-0287Search in Google Scholar

14. Gross, J, Dirzus, I. Die Laborzentralisierung und die Entwicklung der Pathologischen und Klinischen Biochemie an der Charité. Z Med Labdiagn 1989;30:83–9.Search in Google Scholar

15. Plebani, M. Clinical laboratories: production industry or medical services? Clin Chem Lab Med 2015;53:995–1004. https://doi.org/10.1515/cclm-2014-1007.Search in Google Scholar

16. Wickham, H. ggplot2. Cham: Springer International Publishing; 2016.10.1007/978-3-319-24277-4Search in Google Scholar

17. RStudio Team. RStudio: Integrated Development Environment for R Studio. Boston, Ma: PBC; 2020.Search in Google Scholar

18. Conn, JJ, Sebastian, MJ, Deam, D, Tam, M, Martin, FI. A prospective study of the effect of nonionic contrast media on thyroid function. Thyroid 1996;6:107–10. https://doi.org/10.1089/thy.1996.6.107.Search in Google Scholar

19. Martin, FI, Tress, BW, Colman, PG, Deam, DR. Iodine-induced hyperthyroidism due to nonionic contrast radiography in the elderly. Am J Med 1993;95:78–82. https://doi.org/10.1016/0002-9343(93)90235-h.Search in Google Scholar

20. Zhang, S, Cheng, F, Wang, H, Wen, J, Zeng, J, Zhang, C, et al.. Comparability of thyroid-stimulating hormone immunoassays using fresh frozen human sera and external quality assessment data. PLoS One 2021;16:e0253324. https://doi.org/10.1371/journal.pone.0253324.Search in Google Scholar PubMed PubMed Central

21. Di Cerbo, A, Quagliano, N, Napolitano, A, Pezzuto, F, Iannitti, T, Di Cerbo, A. Comparison between an emerging point-of-care tool for TSH evaluation and a centralized laboratory-based method in a cohort of patients from Southern Italy. Diagnostics 2021;11:1590. https://doi.org/10.3390/diagnostics11091590. 34573932.Search in Google Scholar PubMed PubMed Central

22. Reference Institute for Bioanalytics. Surveys Hormones Group 1 2021: TSH [Internet]. RfB; 2021. Available from: https://rfb.bio/cgi/results?rv_type=HM&rvTypeForDetails=HM&year=2021&rv_num=2&analyte=all&searchType=rv_type.Search in Google Scholar

23. Walger, M. Publication of the English version of the Rili-BAEK guideline – the diagnostics industry’s view on the Rili-BAEK guideline and its ramifications on laboratory medicine in Germany. LaboratoriumsMedizin 2015;39:21. https://doi.org/10.1515/labmed-2015-0012.Search in Google Scholar

24. Bolodeoku, J, Bains, S, Pinkney, S, Coker, O, Kim, TK, Anyaeche, C. An evaluation of the Boditech i-CHROMATM thyroid-stimulating hormone(TSH) method: precision and accuracy. Ann Clin Lab Res 2019;7:302.Search in Google Scholar

25. Männistö, T, Surcel, H-M, Bloigu, A, Ruokonen, A, Hartikainen, A-L, Järvelin, M-R, et al.. The effect of freezing, thawing, and short- and long-term storage on serum thyrotropin, thyroid hormones, and thyroid autoantibodies: implications for analyzing samples stored in serum banks. Clin Chem 2007;53:1986–7. https://doi.org/10.1373/clinchem.2007.091371.Search in Google Scholar PubMed


Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2022-0054).


Received: 2022-01-20
Accepted: 2022-03-31
Published Online: 2022-04-25
Published in Print: 2022-06-27

© 2022 Walter de Gruyter GmbH, Berlin/Boston

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