Newswise — South San Francisco—Tosoh Bioscience is proud to showcase Biotin Interference Free immunoassay testing at AACC 2017 in San Diego, CA from July 30 to August 3. Tosoh’s full AIA-PACK® test menu offers a complete line of immunoassay tests that are all free from biotin interference.

Biotin-based immunoassays are exposed to interference risk because endogenous biotin from supplement intake can compete with biotinylated antibodies or biotinylated analyte analogues for binding sites on streptavidin attached to magnetic particles. Some immunoassays like 25-OH Vitamin D are more susceptible to biotin inference than other assays.1

More than 66 percent of adults in the United States take dietary supplements, which can include biotin,2 an essential vitamin which enhances skin, nerve, and digestive system health as well as embryonic development. This vitamin also supports energy release and the metabolism of proteins, carbohydrates, and fats. Biotin deficiency can lead to neurological disease and affect the growth of hair and skin cells.

Many over-the-counter supplements contain biotin megadoses, up to 10 mg per pill, which is more than 300 times the recommended daily intake.3 Consumption of a 1.5 mg dose of biotin has been linked to an unexpectedly low parathyroid hormone (PTH) level.4 Healthy study participants who consumed 15 mg to 30 mg of biotin daily were shown to have biotin concentrations of over 30 ng/mL; these levels could interfere with biotin-based immunoassays.1

The increasing consumption of biotin megadoses have heightened the risk of laboratories reporting erroneous results that could lead to misdiagnosis. At the decision cut-off value, even very low interference may result in misdiagnosis and possible risk to patient safety. The vitamin megatrend seems likely to continue; perhaps the only definitive mitigation strategy for biotin interference risk is use of biotin-free immunoassay platforms.

Tosoh immunoassays are free from biotin interference!



  1. Clerico A, Plebani M. Biotin interference on immunoassay methods: sporadiccases or hidden epidemic? Clin Chem Lab Med. 2017;55(6):777-779.
  2. Moloughney S. Positioning the supplement market for long‐term success.Nutraceuticals World. 2016.
  3. Paxton A. Beauty fad's ugly downside: test interference. CAP Today Online. 2016.‐fads‐ugly‐downsidetest‐interference/
  4. Waghray A, Milas M, Nyalakonda K, Siperstein AE. Falsely low parathyroid hormone secondary to biotin interference: a case series. Endocrine Practice. 2013;19(3)1-14.




Tosoh Bioscience, Inc. provides highly sophisticated diagnostic systems for immunoassay and HPLC testing to doctor’s offices, hospitals and reference laboratories throughout the Americas. Based in South San Francisco, CA, TBI is a U.S. subsidiary of Tosoh Corporation which is headquartered in Tokyo, Japan. TBI is part of Tosoh Corporation’s Bioscience Division.



Lori Lai

Senior AIA-CL Product Manager

[email protected]

Tosoh Bioscience, Inc.

6000 Shoreline Court, Suite 101

South San Francisco, CA 94080 USA

Tel: +1 (800) 248-6764 Fax: +1 (650) 615-0415

[email protected]