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



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.


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.


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.


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.


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Supplementary Material

The online version of this article offers supplementary material (

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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