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A novel point-of-care device accurately measures thyrotropin in whole blood, capillary blood and serum

  • George J. Kahaly EMAIL logo , Johannes Lotz , Sara Walder , Cara Hammad , Rebecca Krämer , Lara Frommer , Jochem König , Jan Wolf , Ulrike Gottwald-Hostalek , Bogumila Urgatz and Karl J. Lackner
Published/Copyright: August 12, 2022
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 60 Issue 10

Abstract

Objectives

Point-of-care (POC) measurement of thyrotropin (TSH) may facilitate prompt diagnosis of thyroid dysfunction. We evaluated the analytical performance of a new POC TSH assay (Wondfo).

Methods

TSH measurements were made from 730 consecutive, unselected subjects in an outpatient setting, using Wondfo in whole blood, capillary blood and serum or automated reference equipment (serum only).

Results

TSH measurements were user-independent. Total intra-and inter-assay variation (CV%) was 12.1 and 16.2%, respectively. Total CV% was 10.6–22.6% and 14.5–21.6% in serum and whole blood, respectively. Linearity was very good. Recovery rate was 97–127%. Prolongation of incubation time increased TSH results of 12% (13%) and 33% (35%) after 2 and 5 additional minutes in serum (blood), respectively. When measured simultaneously in two Wondfo devices, the slope of the regression line was 1.03 (serum) and 1.02 (blood), with Spearman’s correlation of 0.99 for both. TSH measurements between Wondfo and reference correlated strongly (r=0.93–0.96), though TSH measurements were lower with Wondfo (slopes of plots of measurements made using the two devices were 0.94 [serum vs. serum]; 0.83 [whole blood vs. serum] and 0.64 [capillary blood vs. serum]). Depending on sample material, TSH in capillary blood was lower vs. whole blood (slope: 0.82) and for whole blood vs. serum (Wondfo and reference method; slope: 0.69 and 0.83). Total haemolysis, but not elevated bilirubin or lipemia, disrupted TSH measurement.

Conclusions

The Wondfo system was straightforward to use without need for specialist technicians and demonstrated analytic performance suitable for clinical use for the diagnosis of thyroid dysfunction.

Keywords: hyperthyroidism; hypothyroidism; point-of-care testing; thyrotropin
Corresponding author: Prof. George J. Kahaly, Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz 55101, Germany, Phone: +49 6131 17 3460 (2290), Fax: +49 6131 17 3460 (2290), E-mail:
George J. Kahaly and Johannes Lotz contributed equally to this work and share first authorship.

Funding source: WONDFO Biotech Co., Guangzhou, China

Funding source: Merck Healthcare KGaA, Darmstadt, Germany

Acknowledgments

The authors are grateful to the Thyroid Lab Team of the JGU Medical Center, Mainz, Germany for the fruitful discussions during the study. This manuscript encompasses parts of the PhD theses of SW, CH and RK.

  1. Research funding: The JGU Medical Center received research-associated funding and logistical material from Merck Healthcare KGaA, Darmstadt, Germany and Wondfo Biotech Co., Guangzhou, China, respectively. A medical writer (Dr. Mike Gwilt, GT Communications) provided editorial assistance, funded by Merck Healthcare KGaA. All experimental work, analysis and interpretation of data were conducted solely at the Johannes Gutenberg University (JGU) Medical Center, Mainz, Germany. Merck Healthcare KGaA reviewed the manuscript for factual accuracy, according to their regulatory requirements.

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

  3. Competing interests: UGH and BU are Merck Healthcare KGaA employees. All other authors declare 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). The local Institutional Review Board deemed the study exempt from review.

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2022-0525).

Received: 2022-05-30
Accepted: 2022-07-22
Published Online: 2022-08-12
Published in Print: 2022-09-27

© 2022 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2022-0525
Keywords for this article
hyperthyroidism; hypothyroidism; point-of-care testing; thyrotropin

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. The relevance of establishing method-dependent decision thresholds of serum folate in pregnancy and lactation: when the laboratory stewardship meets the health-care needs
  4. Reviews
  5. Strategies to minimise the current disadvantages experienced by women in faecal immunochemical test-based colorectal cancer screening
  6. What is the impact of circulating histones in COVID-19: a systematic review
  7. Mini Review
  8. Diagnostic utility of pleural cell-free nucleic acids in undiagnosed pleural effusions
  9. Guidelines and Recommendations
  10. Evaluation of the cardiovascular risk in patients undergoing major non-cardiac surgery: role of cardiac-specific biomarkers
  11. Genetics and Molecular Diagnostics
  12. Detection of DNA copy number alterations by matrix-assisted laser desorption/ionization time-of-flight mass spectrometric analysis of single nucleotide polymorphisms
  13. General Clinical Chemistry and Laboratory Medicine
  14. Fifty years of newborn screening for congenital hypothyroidism: current status in Australasia and the case for harmonisation
  15. Commutability assessment of reference materials for homocysteine
  16. External quality assessment for detection of methylated Syndecan 2 (SDC2) in China
  17. Patient-based real-time quality control for quantitative hepatitis B virus DNA test using moving rate of positive and negative patient results
  18. Performance of HDL-C measurements assessed by a 4-year trueness-based EQA/PT program in China
  19. Two-site evaluation of the Roche Elecsys Vitamin D total III assay
  20. A novel point-of-care device accurately measures thyrotropin in whole blood, capillary blood and serum
  21. IgA rheumatoid factor in rheumatoid arthritis
  22. Reference Values and Biological Variations
  23. Reference intervals of 14 biochemical markers for children and adolescence in China: the PRINCE study
  24. Chinese normotensive and essential hypertensive reference intervals for plasma aldosterone and renin activity by liquid chromatography-tandem mass spectrometry
  25. Biological variation estimates obtained from Chinese subjects for 32 biochemical measurands in serum
  26. Cancer Diagnostics
  27. Testosterone analysis in castrated prostate cancer patients: suitability of the castration cut-off and analytical accuracy of the present-day clinical immunoassays
  28. Cardiovascular Diseases
  29. Point-of-care high-sensitivity troponin-I analysis in capillary blood for acute coronary syndrome diagnostics
  30. Platelet count and clinical outcomes among ischemic stroke patients with endovascular thrombectomy in DIRECT-MT
  31. Infectious Diseases
  32. Measurement of anti SARS-CoV-2 RBD IgG in saliva: validation of a highly sensitive assay and effects of the sampling collection method and correction by protein
  33. Letters to the Editors
  34. The simple reproducibility of a measurement result does not equal its overall measurement uncertainty
  35. Complexity of serological assays and misunderstandings of WHO International Units
  36. Ct values of different SARS CoV2 variants: a single center observational study from Innsbruck, Austria
  37. Alignment of the new generation of Abbott Alinity γ-glutamyltransferase assay to the IFCC reference measurement system should be improved
  38. Thermal and chronological stability of monocyte distribution width (MDW), the new biomarker for sepsis
  39. Two comments for the current commutability assessment
  40. Plasma neurofilament light chain in Chinese children with later-onset spinal muscular atrophy
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