Biotin interference in assays for thyroid hormones, thyrotropin and thyroglobulin
Open accessAbstract
Background: Biotin has been reported to interfere with several commonly used laboratory assays resulting in misleading values and possible erroneous diagnosis and treatment. This report describes a prospective study of possible biotin interference in thyroid-related laboratory assays, with a comparison of different commonly used assay platforms. Materials and Methods: Thirteen adult subjects (mean age 45 ± 13 years old) were administered biotin 10 mg/day for eight days. Blood specimens were collected at three time points on day 1 and on day 8 (baseline, two, and five hours after biotin ingestion). Thyrotropin (TSH), free triiodothyronine (fT3), free thyroxine (fT4), total triiodothyronine (TT3), total thyroxine (TT4), thyroxine binding globulin (TBG), and thyroglobulin (Tg) levels were analyzed with four different platforms: Abbott Architect, Roche Cobas 6000, Siemens IMMULITE 2000, and liquid chromatography with tandem mass spectrometry (LC-MS/MS). TSH, fT3, fT4, TT3, and TT4 were measured with Abbott Architect and Roche Cobas 6000. fT3, fT4, TT3, and TT4 were also measured by LC-MS/MS. Tg was measured by Siemens IMMULITE 2000. TBG was assessed with Siemens IMMULITE 2000. Results: Significant changes in TSH, fT4, and TT3 measurements were observed after biotin exposure when the Roche Cobas 6000 platform was used. Biotin intake resulted in a falsely lower Tg level when measurements were performed with Siemens IMMULITE 2000. At the time points examined, maximal biotin interference was observed two hours after biotin exposure both on day 1 and day 8. Conclusions: A daily dose of 10 mg was shown to interfere with specific assays for TSH, fT4, TT3, and Tg. Physicians must be aware of the potential risk of erroneous test results in subjects taking biotin supplements. Altered test results for TSH and Tg can be particularly problematic in patients requiring careful titration of levothyroxine therapy such as those with thyroid cancer.
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Biotin may interfere with some T4 assay systems.
“while biotin may interfere with some T4 assay systems (79, 80).”
From ETA guidelines for the use of levothyroxine sodium preparations in monotherapy to optimize the treatment of hypothyroidism (2025) · cites this paper as [80]
Phenytoin, carbamazepine, salsalate, salicylate, furosemide, diclofenac, ethacrynic acid, and heparin have been observed in vitro to displace T4 from distribution proteins, changing the amount of thyroxine bound to plasma protein.
“A number of drugs, such as phenytoin, carbamazepine, salsalate, salicylate, furosemide, diclofenac, ethacrynic acid, and heparin, have been observed in vitro to displace T4 from the distribution proteins, changing the amount of thyroxine bound to plasma protein”
From ETA guidelines for the use of levothyroxine sodium preparations in monotherapy to optimize the treatment of hypothyroidism (2025) · cites this paper as [80]
Assay architecture-specific effects such as biotin interference have been frequently reported.
“Assay architecture-specific effects such as biotin interference have also been frequently reported.126”
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References 33 · Cited by 44
- Authors
- Ylli, D., Soldin, S. J., Stolze, B., Wei, B., Nigussie, G., Nguyen, H., Mendu, D. R., Mete, M., Wu, D., Gomes-Lima, C. J., Klubo-Gwiezdzinska, J., Burman, K. D., & Wartofsky, L.
- Affiliations
- University of Medicine Tirana (AL)
- National Institutes of Health (US)
- Mount Sinai Hospital (US)
- MedStar Washington Hospital Center (US)
- National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, USA.
- Corresponding author
- Wartofsky, Leonard
- ORCID
- Venue
- Thyroid
- Publisher
- SAGE Publications
- Published
- 2021-08
- Volume
- 31
- Issue
- 8
- Pages
- 1160-1170
- ISSN
- 1050-7256 (ISSN-L)
- 1557-9077
- PMC
- PMC8420951
- OpenAlex
- W3165525449
- Cited by
- 44
- References
- 33
- Citations by year
- 2026: 9 · 2025: 8 · 2024: 10 · 2023: 9 · 2022: 4 · 2021: 3
- FWCI
- 4.08
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Thyroid (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Disorders and Treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cell Biology › Biotin and Related Studies
- Keywords
- biotin interference, thyroid function tests, thyroid-stimulating hormone, thyroglobulin, free thyroxine, free triiodothyronine, thyroxine-binding globulin, biotin supplementation, thyroid cancer
- MeSH terms
- Adult, Aged, Biotin, Chromatography, High Pressure Liquid, False Negative Reactions, Female, Humans, Male, Middle Aged, Prospective Studies, Mass Spectrometry, Thyroglobulin, Thyroid Function Tests, Thyroid Hormones, Thyrotropin
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