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Licensed Unlicensed Requires Authentication Published by De Gruyter August 12, 2022

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



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).


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).


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.


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.

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


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 (

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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