Startseite Evaluation of the AFIAS-1 thyroid-stimulating hormone point of care test and comparison with laboratory-based devices
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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 und Astrid Petersmann
Veröffentlicht/Copyright: 25. April 2022
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Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 60 Heft 7

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.

Keywords: AFIAS-1; point of care; thyroid stimulating hormone
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 (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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https://doi.org/10.1515/cclm-2022-0054
Schlagwörter für diesen Artikel
AFIAS-1; point of care; thyroid stimulating hormone

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. The never-ending quest for antibody assays standardization and appropriate measurement units
  4. Review
  5. Glycated albumin in diabetes mellitus: a meta-analysis of diagnostic test accuracy
  6. Opinion Paper
  7. Ad interim recommendations for diagnosing SARS-CoV-2 infection by the IFCC SARS-CoV-2 variants working group
  8. Guidelines and Recommendations
  9. Recommendations for IVDR compliant in-house software development in clinical practice: a how-to paper with three use cases
  10. General Clinical Chemistry and Laboratory Medicine
  11. Comparison between polynomial regression and weighted least squares regression analysis for verification of analytical measurement range
  12. Transport stability profiling – a proposed generic protocol
  13. Impact of ultra-low temperature long-term storage on the preanalytical variability of twenty-one common biochemical analytes
  14. Development of a liquid chromatography mass spectrometry method for the determination of vitamin K1, menaquinone-4, menaquinone-7 and vitamin K1-2,3 epoxide in serum of individuals without vitamin K supplements
  15. TSH-receptor autoantibodies in patients with chronic thyroiditis and hypothyroidism
  16. Evaluation of the AFIAS-1 thyroid-stimulating hormone point of care test and comparison with laboratory-based devices
  17. Lack of analytical interference of dydrogesterone in progesterone immunoassays
  18. A comprehensive comparison between ISAC and ALEX2 multiplex test systems
  19. Detection of subarachnoid haemorrhage with spectrophotometry of cerebrospinal fluid – a comparison of two methods
  20. Importance of cerebrospinal fluid storage conditions for the Alzheimer’s disease diagnostics on an automated platform
  21. Estimating urine albumin to creatinine ratio from protein to creatinine ratio using same day measurement: validation of equations
  22. An automated, rapid fluorescent immunoassay to quantify serum soluble programmed death-1 (PD-1) protein using testing-on-a-probe biosensors
  23. Hematology and Coagulation
  24. The VES-Matic 5 system: performance of a novel instrument for measuring erythrocyte sedimentation rate
  25. Cancer Diagnostics
  26. Is thyroglobulin a reliable biomarker of differentiated thyroid cancer in patients treated by lobectomy? A systematic review and meta-analysis
  27. Cardiovascular Diseases
  28. The intra-individual variation of cardiac troponin I: the effects of sex, age, climatic season, and time between samples
  29. Infectious Diseases
  30. A cohort analysis of SARS-CoV-2 anti-spike protein receptor binding domain (RBD) IgG levels and neutralizing antibodies in fully vaccinated healthcare workers
  31. Patients with severe COVID-19 do not have elevated autoantibodies against common diagnostic autoantigens
  32. Cerebrospinal fluid markers of inflammation and brain injury in Lyme neuroborreliosis – a prospective follow-up study
  33. Letters to the Editors
  34. Misleading nomenclature of units of WHO materials used for standardization of SARS COv-2 serology
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  40. (In)direct chloride ISE measurements, room for improvement
  41. New concept of interactive academic poster used in medical scientific congress presented in the EuroMedLab 2021 Munich Session
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