Biotin Interference

ARUP’s Commitment

On November 28, 2017, the FDA issued a Safety Communication warning that “Biotin May Interfere with Lab Tests.”

ARUP sent an announcement to clients regarding the FDA warning on December 6, 2017. ARUP has also identified the tests that can potentially be affected by high levels of biotin and has started contacting kit manufacturers to investigate biotin interference.

Please be assured that ARUP is responding to the FDA notification in a manner that is consistent with our commitment to quality and patient care. At this time, ARUP encourages healthcare providers to interpret associated clinical results for patients that are taking high levels of biotin with caution.

For additional questions, please contact ARUP Client Services at (800) 522-2787, and refer to the key word: Biotin Interference.

About Biotin

Biotin (vitamin B7) is a water-soluble B vitamin that helps turn carbs, fats, and proteins into energy. The recommended daily intake (RDI) varies based on age (adults: 30 µg/day). Biotin can be found in various foods, as well as multivitamins, prenatal vitamins, and dietary supplements.2 However, dietary supplements marketed for hair, skin, and nail growth may contain biotin concentrations up to 650 times (5–10 mg) the RDI. High dose supplementation of biotin (>10 mg/day) may be recommended for patients with certain inherited metabolic deficiencies/diseases or conditions such as multiple sclerosis (MS). 1,3

Potential Effect(s) on Testing

While standard intake levels of biotin do not typically cause interference, higher levels may cause significant interference with certain immunoassays that use biotin-streptavidin technology and affect corresponding test results.1,3 This interference can cause false highs and false lows, potentially leading to misdiagnosis.

Patients may be unaware they are taking higher-than-recommended levels of biotin, so it is important for physicians to be diligent in obtaining a full list of supplements for testing accuracy. This information should then be communicated with the lab(s) conducting the test(s). For suspicious or inconsistent patient results, biotin interference may be considered. Consult with testing laboratory to discuss potential impact.1

References

  1. U.S. Food and Drug Administration. Biotin (vitamin B7): safety communication—may interfere with lab tests. www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586641.htm (accessed on December 20, 2017).
  2. National Institutes of Health. Biotin fact sheet for consumers. ods.od.nih.gov/factsheets/Biotin-Consumer/ (accessed on December 20, 2017).
  3. Roche Diagnostics. Biotin facts. biotinfacts.roche.com (accessed on December 20, 2017).

Additional Resources