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.
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.
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.
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: UGH and BU are Merck Healthcare KGaA employees. All other authors declare no conflict of interest.
Informed consent: Informed consent was obtained from all individuals included in this study.
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.
7. Jonklaas, J, Bianco, AC, Bauer, AJ, Burman, KD, Cappola, AR, Celi, FS, et al.. Guidelines for the treatment of hypothyroidism: prepared by the american thyroid association task force on thyroid hormone replacement. Thyroid 2014;24:1670–751. https://doi.org/10.1089/thy.2014.0028.Search in Google Scholar PubMed PubMed Central
8. Ross, DS, Burch, HB, Cooper, DS, Greenlee, MC, Laurberg, P, Maia, AL, et al.. 2016 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
10. Schols, AM, Dinant, GJ, Cals, JW. Point-of-care testing in general practice: just what the doctor ordered? Br J Gen Pract 2018;68:362–3. https://doi.org/10.3399/bjgp18x698033.Search in Google Scholar PubMed PubMed Central
11. Mitra, P, Sharma, P. POCT in developing countries. EJIFCC 2021;32:195–9.Search in Google Scholar
12. Chesher, D. Evaluating assay precision. Clin Biochem Rev 2008;29:S23–6.Search in Google Scholar
15. Passing, H, Bablok. A new biometrical procedure for testing the equality of measurements from two different analytical methods. Application of linear regression procedures for method comparison studies in clinical chemistry, Part I. J Clin Chem Clin Biochem 1983;21:709–20. https://doi.org/10.1515/cclm.19126.96.36.1999.Search in Google Scholar
16. Passing, H, Bablok, W. Comparison of several regression procedures for method comparison studies and determination of sample sizes. Application of linear regression procedures for method comparison studies in clinical chemistry, part II. J Clin Chem Clin Biochem 1984;22:431–45. https://doi.org/10.1515/cclm.19188.8.131.521.Search in Google Scholar
17. Weigl, BH, Neogi, T, McGuire, H. Point-of-care diagnostics in low-resource settings and their impact on care in the age of the noncommunicable and chronic disease epidemic. J Lab Autom 2014;19:248–57. https://doi.org/10.1177/2211068213515246.Search in Google Scholar
18. 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 (Basel) 2021;11:1590. https://doi.org/10.3390/diagnostics11091590.Search in Google Scholar
19. Joseph, J, Vasan, JK, Shah, M, Sivaprakasam, M, Mahajan, L. iQuant analyser: a rapid quantitative immunoassay reader. Annu Int Conf IEEE Eng Med Biol Soc 2017;2017:3732–6.10.1109/EMBC.2017.8037668Search in Google Scholar
20. Wang, T, Sheng, S, Ruan, M, Yan, J, Gu, J, Jiang, Y, et al.. Clinical evaluation of the immune colloidal gold method for rapid qualitative and quantitative measurement of thyroid-stimulating hormone as an assay for hypothyroidism. Adv Ther 2016;33:2001–11. https://doi.org/10.1007/s12325-016-0401-y.Search in Google Scholar
21. von Lode, P, Hagren, V, Palenius, T, Lovgren, T. One-step quantitative thyrotropin assay for the detection of hypothyroidism in point-of-care conditions. Clin Biochem 2003;36:121–8. https://doi.org/10.1016/s0009-9120(02)00431-9.Search in Google Scholar
22. Znoyko, SL, Orlov, AV, Bragina, VA, Nikitin, MP, Nikitin, PI. Nanomagnetic lateral flow assay for high-precision quantification of diagnostically relevant concentrations of serum TSH. Talanta 2020;216:120961. https://doi.org/10.1016/j.talanta.2020.120961.Search in Google Scholar PubMed
23. You, DJ, Park, TS, Yoon, JY. Cell-phone-based measurement of TSH using Mie scatter optimized lateral flow assays. Biosens Bioelectron 2013;40:180–5. https://doi.org/10.1016/j.bios.2012.07.014.Search in Google Scholar PubMed
24. Jeong, JH, Kim, TK, Oh, SW, Choi, EY. Fluorescence immunochip assay for thyroid stimulating hormone in whole blood. Biochip J 2013;7:408–14. https://doi.org/10.1007/s13206-013-7413-3.Search in Google Scholar
25. Padoan, A, Clerico, A, Zaninotto, M, Trenti, T, Tozzoli, R, Aloe, R, et al.. Percentile transformation and recalibration functions allow harmonization of thyroid-stimulating hormone (TSH) immunoassay results. Clin Chem Lab Med 2020;58:1663–72. https://doi.org/10.1515/cclm-2019-1167.Search in Google Scholar PubMed
26. Mirjanic-Azaric, B, Jerin, A, Radic, Z. Thyroid stimulating hormone values of clinical decisions of hypothyroidism measurement by three different automated immunoassays. Scand J Clin Lab Invest 2020;80:151–5. https://doi.org/10.1080/00365513.2019.1703215.Search in Google Scholar PubMed
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