How Does Biotin Supplementation Impact Laboratory Results, and Influence Diagnosis and Treatment of Endocrine Disorders?

In assessing results of endocrine hormone levels, clinicians are cautioned to verify biotin supplementation to avoid false lab results, and a misdiagnosis of thyroid disorders.

Written by Tamara Khutorskoy MD, David Bleich MD

Our experts respond to a very timely concern about the evident interference of biotin in laboratory testings.1

Biotin, also known as B7, or water-soluble vitamin H, is a cofactor in enzymatic carboxylation reactions of fatty acid and branched chain amino acid metabolism, gluconeogenesis, and the Kreb’s cycle.2,3 While the recommended daily intake of biotin is 30 mcg for adults, the average intake of this micronutrient in Western diets is about 35-70 mcg daily.4

Approximately 15-20% of US adults take supraphysiologic doses of biotin-containing supplements for common hair and skin problems, weight loss, enhanced glucose metabolism, and to boost energy.4 Biotin also has pharmacologic indications for multiple sclerosis, malabsorption syndrome, dysregulation of mitochondrial energy metabolism, biotin-thiamin responsive basal ganglia disease, and genetic biotin deficiency.It is also used in alleviating muscle cramps in hemodialysis patients.

Unfortunately, when consumed in high doses typically found in over the counter supplements, biotin interferes with the biotin-streptavidin system used in many immunoassays.The biotin-streptavidin complex is reliable for its strong non-covalent bond. The strong affinity of biotin to streptavidin makes it resistant to organic solvents, denaturants, detergents, proteolytic enzymes, as well as extremes of temperature and pH.

Impact of Biotin on Immunoassays

An excess biotin intake may adversely effect immunoassays in two different ways:

For a list of common endocrine-related competitive and sandwich assays that may return inaccurate findings in the presence of biotin supplementation see Table 1.

Potential for Clinical Misdiagnosis 

There are many erroneous biochemical diagnoses that may occur in patients taking high dosages of supplemental biotin.

Imagine, for example, a case in which lab results on a patient indicate elevated free thyroxine, elevated free triiodothyronine, elevated TSH receptor antibodies as well as a low TSH. A clinician would view this constellation of findings as indicative of possible Graves’ disease.

Alternatively, the same constellation of laboratory findings may be obtained for a euthyroid patient taking excessive biotin. Similarly, the laboratory findings for patients treated with testosterone replacement may show a false low or normal PSA levels in the presence of excess biotin supplementation.

Likewise, primary hyperparathyroidism would be difficult to diagnose in patients with hypercalcemia and falsely low PTH. It is of utmost importance to obtain a comprehensive history of biotin use when conducting an initial intake of all medications taken, and again before bloods are drawn to assess endocrine hormone levels to avoid the potential for misdiagnosing a patient without assurance that biotin is not a contributory factor to the results.

Need for More Assertive Interaction with Patients

Clinicians are cautioned to act decisively given the risk of inaccurate or missed diagnosis and in light of the urgency that prompted a Food and Drug Administration (FDA) Safety Communication on this very topic.  

The FDA recommends1 that clinicians take the following precautions:

  • Talk to your patients about any biotin supplements they may be taking, including supplements marketed for hair, skin, and nail growth
  • Be aware that many lab tests, including but not limited to cardiovascular diagnostic tests and hormone tests, that use biotin technology are potentially affected, and incorrect test results may be generated if there is biotin in the patient’s specimen
  • Communicate to the lab conducting the testing if your patient is taking biotin
  • If a lab test result doesn’t match the clinical presentation of your patient, consider biotin interference as a possible source of error
  • Know that biotin is found in multivitamins, including prenatal multivitamins, biotin supplements, and dietary supplements for hair, skin, and nail growth in levels that may interfere with lab tests
  • Report to the lab test manufacturer and the FDA if you become aware of a patient experiencing an adverse event following potentially incorrect laboratory test results due to biotin interference.

The FDA reports taking the following actions—working with stakeholders to better understand biotin interference with laboratory tests in order to develop recommendations for more accurate testing in patients who have taken high levels of biotin in advance of laboratory testing.1

For specific directives in the FDA Safety Communication, go to: FDA.

 

 

Sources

  1. Mock DM. Biotin. In: Ross AC, Caballero B, Cousins RJ, Tucker KL, Ziegler TR, eds. Modern Nutrition in Health and Disease. 11th ed. Baltimore, MD: Lippincott Williams & Wilkins; 2014:390-398.
  2. Food and Drug Administration. The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication. November 28, 2017. Available at: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm586505.htm. Accessed January 2, 2018.
  3. Khutorskoy T. The Effects of Biotin Supplementation on Immunoassays. Presented at: New Jersey-American Association of Clinical Endocrinologists. November 1, 2017. Bridgewater, New Jersey.
  4. “Office of Dietary Supplements - Biotin.” NIH Office of Dietary Supplements, U.S. Department of Health and Human Services. Available at: www.ods.od.nih.gov/factsheets/Biotin-HealthProfessional/#h2. Accessed October 2, 2017.
  5. National Research Council. Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline. Washington, DC: National Academy Press; 1998. 

Continue Reading

Selection and Timing of Assay Enhances Post-Surgery Thyroid Cancer Care