-
Research funding: None declared.
-
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
-
Competing interests: Authors state no conflict of interest.
-
Informed consent: Not applicable.
-
Ethical approval: Not applicable.
References
1. Park, JYPK. Immunochemical techniques. In: Rifai, NCR, Burnham, CAD, Wittwer, CT, editors. Tietz textbook of laboratory medicine. St. Louis, MO: Elsevier; 2022.Search in Google Scholar
2. Wauthier, L, Plebani, M, Favresse, J. Interferences in immunoassays: review and practical algorithm. Clin Chem Lab Med 2022;60:808–20. https://doi.org/10.1515/cclm-2021-1288.Search in Google Scholar PubMed
3. Favresse, J, Burlacu, MC, Maiter, D, Gruson, D. Interferences with thyroid function immunoassays: clinical implications and detection algorithm. Endocr Rev 2018;39:830–50. https://doi.org/10.1210/er.2018-00119.Search in Google Scholar PubMed
4. Nevraumont, A, Deltombe, M, Favresse, J, Guillaume, L, Chapelle, V, Twerenbold, R, et al.. Interferences with cardiac biomarker assays: understanding the clinical impact. Eur Heart J 2022;43:2286–8. https://doi.org/10.1093/eurheartj/ehab924.Search in Google Scholar PubMed
5. Dasgupta, A, Wahed, A. Biotin interferences with immunoassays. In: Clinical chemistry, immunology and laboratory quality control. St. Louis, MO: Elsevier; 2021:445–55 pp.10.1016/B978-0-12-815960-6.00019-4Search in Google Scholar
6. Food and Drug Administration, Center for Biologics Evaluation and Research and Center for Devices and Radiological Health. UPDATE: the FDA warns that biotin may interfere with lab tests: FDA safety communication. Available from: https://www.fda.gov/medical-devices/safety-communications/update-fda-warns-biotin-may-interfere-lab-tests-fda-safety-communication [Accesed 16 Jan 2023].Search in Google Scholar
7. Li, D, Rooney, MR, Burmeister, LA, Basta, NE, Lutsey, PL. Trends in daily use of biotin supplements among US adults, 1999–2016. JAMA 2020;324:605–7. https://doi.org/10.1001/jama.2020.8144.Search in Google Scholar PubMed PubMed Central
8. Food and Drug Administration. Testing for biotin interference in in vitro diagnostic devices – guidance for industry; 2020. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/testing-biotin-interference-in-vitro-diagnostic-devices [Accessed 2 Feb 2022].Search in Google Scholar
9. Trambas, C, Lu, Z, Yen, T, Sikaris, K. Characterization of the scope and magnitude of biotin interference in susceptible Roche Elecsys competitive and sandwich immunoassays. Ann Clin Biochem 2018;55:205–15. https://doi.org/10.1177/0004563217701777.Search in Google Scholar PubMed
10. Favresse, J, Schiettecatte, J, Wolff, F, Cotton, F, Elsen, M, Eucher, C, et al.. Two-site evaluation of the Roche Elecsys vitamin D total III assay. Clin Chem Lab Med 2022;60:1598–606. https://doi.org/10.1515/cclm-2022-0177.Search in Google Scholar PubMed
11. Aarsand, AK, Fernandez-Calle, P, Webster, C, Coskun, A, Gonzales-Lao, E, Diaz-Garzon, J, et al.. The EFLM biological variation database. Available from: https://biologicalvariation.eu/ [Accessed 2 Feb 2022].Search in Google Scholar
12. Mzougui, S, Favresse, J, Soleimani, R, Fillee, C, Gruson, D. Biotin interference: evaluation of a new generation of electrochemiluminescent immunoassays for high-sensitive troponin T and thyroid-stimulating hormone testing. Clin Chem Lab Med 2020;58:2037–45. https://doi.org/10.1515/cclm-2020-0214.Search in Google Scholar PubMed
13. Mumma, B, Diercks, D, Twerenbold, R, Valcour, A, Ziegler, A, Schützenmeister, A, et al.. Clinical risk assessment of biotin interference with a high-sensitivity cardiac troponin T assay. Clin Chem Lab Med 2020;58:1931–40. https://doi.org/10.1515/cclm-2019-0962.Search in Google Scholar PubMed
14. von Meyer, A, Albert, G, Kunzelmann, S, Rank, C, Zerback, R, Imdahl, R. Evaluating the performance of an updated high-sensitivity troponin T assay with increased tolerance to biotin. Clin Chem Lab Med 2021;59:591–7. https://doi.org/10.1515/cclm-2020-0104.Search in Google Scholar PubMed
15. Evenepoel, A, Schiettecatte, J, Van Dalem, A, Anckaert, E. Biotin interference: evaluation of an updated thyroglobulin electrochemiluminescent immunoassay. Clin Chem Lab Med 2021;60:e46–9. https://doi.org/10.1515/cclm-2021-0969.Search in Google Scholar PubMed
16. Vroemen, WHM, van Doorn, W, Kimenai, DM, Wodzig, W, de Boer, D, Bekers, O, et al.. Biotin interference in high-sensitivity cardiac troponin T testing: a real-world evaluation in acute cardiac care. Cardiovasc Res 2019;115:1950–1. https://doi.org/10.1093/cvr/cvz277.Search in Google Scholar PubMed PubMed Central
17. Holmes, EW, Samarasinghe, S, Emanuele, MA, Meah, F. Biotin interference in clinical immunoassays: a cause for concern. Arch Pathol Lab Med 2017;141:1459–60. https://doi.org/10.5858/arpa.2017-0107-le.Search in Google Scholar
18. Food and Drug Administration. Biotin interference with troponin lab tests – assays subject to biotin interference. Available from: https://www.fda.gov/medical-devices/in-vitro-diagnostics/biotin-interference-troponin-lab-tests-assays-subject-biotin-interference [Accessed 2 Feb 2022].Search in Google Scholar
Supplementary Material
This article contains supplementary material (https://doi.org/10.1515/cclm-2023-0242).
© 2023 Walter de Gruyter GmbH, Berlin/Boston
