A caution regarding high-dose biotin therapy: misdiagnosis of hyperthyroidism in euthyroid patients

Christina M Trambas, Kenneth A Sikaris and Zhong X Lu
Med J Aust 2016; 205 (4): . || doi: 10.5694/mja16.00544
Published online: 15 August 2016

High-dose biotin therapy is finding favour as a promising novel agent in the treatment of multiple sclerosis.1 We feel compelled to alert clinicians to an easily overlooked aspect of biotin therapy that has the potential to cause significant harm: it causes profound interference with immunoassays that are based on streptavidin–biotin technology.2,3 Such assays are widely used in routine laboratories. Depending on the method principle, biotin interference may cause falsely high results (typically in competitive immunoassays) or falsely low results (typically in sandwich immunoassays).4 This interference may produce a pattern of results that closely resembles disease, leading to false diagnoses, inappropriate treatment and risk of complications.

  • 1 Melbourne Pathology, Melbourne, VIC
  • 2 Monash University, Melbourne, VIC


Competing interests:

No relevant disclosures.

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  • 2. Henry JG, Sobki S, Arafat N. Interference by biotin therapy on measurement of TSH and FT4 by enzyme immunoassay on Boehringer Mannheim ES700 analyser. Ann Clin Biochem 1996; 33: 162-163.
  • 3. Wijeratne NG, Doery JCG, Lu ZX. Positive and negative interference in immunoassays following biotin ingestion: a pharmacokinetic study. Pathology 2012; 44: 674-675.
  • 4. Barbesino G. Misdiagnosis of Graves’ disease with apparent severe hyperthyroidism in a patient taking biotin megadoses. Thyroid 2016; 26: 860-863.
  • 5. Peyro Saint Paul L, Debruyne D, Bernard D, et al. Pharmacokinetics and pharmacodynamics of MD1003 (high-dose biotin) in the treatment of progressive multiple sclerosis. Expert Opin Drug Metab Toxicol 2016; 12: 327-344.


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