Startseite Medizin A novel point-of-care device accurately measures thyrotropin in whole blood, capillary blood and serum
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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 und Karl J. Lackner
Veröffentlicht/Copyright: 12. August 2022
Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 60 Heft 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.

References

1. Gottwald-Hostalek, U, Schulte, B. Low awareness and under-diagnosis of hypothyroidism. Curr Med Res Opin 2022;38:59–64. https://doi.org/10.1080/03007995.2021.1997258.Suche in Google Scholar PubMed

2. Leo, DS, Lee, SY, Braverman, LE. Hyperthyroidism. Lancet 2016;388:906–18. https://doi.org/10.1016/s0140-6736(16)00278-6.Suche in Google Scholar

3. Kahaly, GJ. 70 years of levothyroxine. Basel, Switzerland AG: Springer Nature; 2021.10.1007/978-3-030-63277-9Suche in Google Scholar PubMed

4. Brenta, G. Levothyroxine in children. In: Kahaly, GJ, editor. 70 years of levothyroxine. Basel, Switzerland AG: Springer Nature; 2021:61–72 pp.10.1007/978-3-030-63277-9_5Suche in Google Scholar PubMed

5. Biondi, B. Levothyroxine in the heart. In: Kahaly GJ, editor. 70 years of levothyroxine. Basel, AG: Springer Nature; 2021:85–96 pp.10.1007/978-3-030-63277-9_7Suche in Google Scholar PubMed

6. Teng, W. Levothyroxine and bone. In: Kahaly, GJ, editor. 70 years of levothyroxine. Basel, Switzerland AG: Springer Nature; 2021:97–108 pp.10.1007/978-3-030-63277-9_8Suche in Google Scholar PubMed

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.Suche 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.Suche in Google Scholar PubMed

9. Price, CP. Point of care testing. BMJ 2001;322:1285–8. https://doi.org/10.1136/bmj.322.7297.1285.Suche in Google Scholar PubMed PubMed Central

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.Suche in Google Scholar PubMed PubMed Central

11. Mitra, P, Sharma, P. POCT in developing countries. EJIFCC 2021;32:195–9.Suche in Google Scholar

12. Chesher, D. Evaluating assay precision. Clin Biochem Rev 2008;29:S23–6.Suche in Google Scholar

13. Bablok, W, Passing, H. Application of statistical procedures in analytical instrument testing. J Automat Chem 1985;7:74–9. https://doi.org/10.1155/s1463924685000177.Suche in Google Scholar PubMed PubMed Central

14. Bilic-Zulle, L. Comparison of methods: passing and Bablok regression. Biochem Med 2011;21:49–52. https://doi.org/10.11613/bm.2011.010.Suche in Google Scholar PubMed

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.1983.21.11.709.Suche in Google Scholar PubMed

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.1984.22.6.431.Suche in Google Scholar PubMed

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.Suche in Google Scholar PubMed

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.Suche in Google Scholar PubMed PubMed Central

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.2017.8037668Suche in Google Scholar PubMed

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.Suche in Google Scholar PubMed

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.Suche in Google Scholar PubMed

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.Suche 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.Suche 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.Suche 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.Suche 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.Suche in Google Scholar PubMed

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
Schlagwörter für diesen Artikel
hyperthyroidism; hypothyroidism; point-of-care testing; thyrotropin

Artikel in diesem Heft

  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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