Why should laboratories be worried about Biotin?


Why is Biotin an Issue Now?

Biotin has been a key component of vitamins for years… so why are laboratories being impacted today? Biotin usage and concentration has increased over the last few years due to biotin supplements being utilized to aid healthy hair, skin and nails.

Over the past three years, biotin has seen a significant increase in retail sales. Biotin doses of 10,000 mcg are the number #1 selling supplement on Amazon.

Your laboratory may be unaware of potential biotin interference issues, as the laboratory cannot determine which patients are utilizing biotin supplements. Many of your patients are even unaware that they are taking biotin. The package insert from your biotin-streptavidin laboratory test should provide biotin interference levels, but these levels may not reflect the current doses that patients are taking.

In addition, the metabolism rates of biotin at today’s standard doses is unknown, as biotin binds to proteins and can be present for up to several weeks. Sending patients home or delaying draws is an inconvenience to the patient and the physician, and ultimately biotin may still be in the patient’s system when retested. This issue is further complicated in acute settings where there is an immediate need for laboratory results.

It is important to understand whether biotin interference may impact the tests that your laboratory utilizes.

 
  
 
                                                                                                                
 
 Total Standard Units solid in Europe in 2016*          
                   Biotin Sales in Europe
*Data prepared by IMS Health (now IQVIA) report made in late 2016 for Abbott Gmb H

You can choose tests that are not impacted by BiotinADD-00063620B_BiotinMethod-NotImpacted.png

In blood samples from patients not taking biotin supplements, streptavidin-coated microparticles bind and separate the biotinylated antibodies that have captured the target analyte producing an accurate result.

Immunoassays offered by the Abbott Alinity ci-series and ARCHITECT systems DO NOT utilize the biotin-streptavidin capture method during the sample testing process. Internal testing performed on assays that contain any form of biotin or streptavidin did NOT show any interference due to biotin. 

Biotin-Streptavidin MethodADD-00063620C_BiotinMethod-Impacted.png

In blood samples from patients taking biotin supplements, free biotin molecules can interfere with the ability of streptavidin-coated microparticles to bind and separate the biotinylated antibodies that have captured the target analyte, leading to inaccurate results.

Other considerations for your laboratory

Your laboratory will not know which patients are taking biotin. If your laboratory tests utilize the biotin-streptavidin capture method your results could be impacted. Your laboratory should consider:

  • Educating your physicians on the tests that are potentially impacted by biotin
  • Understanding the impact of biotin interference in the tests that your laboratory utilizes
  • Evaluating critical assays to determine and communicate the impact of biotin on test results that are used for acute care, for example, patients with chest pain
  • Working with key physicians to identify a process to ensure accurate test results

Your laboratory can choose tests not impacted by biotinalinity-ci-series-instrument-image-450x240.png

Have confidence in your laboratory's immunoassay test results and remove the risk of misdiagnosis due to biotin interference… request laboratory tests that are not impacted by biotin, such as the immunoassays offered by the Abbott Alinity ci-series and ARCHITECT systems.

Contact An Abbott Representative

 

                      

  1. Nielsen FDM Data Ending 03/26/16
  2. https://www.amazon.com/s/ref=nb_sb_noss_1?url=search-alias%3Daps&field-keywords=biotin
  3. Google analytics: September 2016
  4. Zempleni J, Kuroishi T. Biotin. Adv Nutr. 2012;3:213-214
  5. Combs GF. Biotin. In: Combs, GF. The Vitamins: Fundamental Aspects in Nutrition and Health. San Diego, CA: Elsevier, Inc.; 2008: 331-3
  6. Grimsey, Paul; Frey, Nicolas; Population pharmacokinetics of exogenous biotin and the relationship between biotin serum levels and in vitro immunoassay interference; Int. J. Pharmacokinet. (2017) 2(4), 247–256
  7. Food and Drug Administration: Biotin (Vitamin 7): Safety Communication- May interfere with Lab tests (November 28th 2017) https://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm586505.htm 
  8. Kummer, S. NEJM August 2016: Biotin Treatment Mimicking Graves’ Disease.
  9. Saint Paul LP, Debruyne D, Bernard D, Mock DM and Defer GL. Pharmacokinetics and pharmacodynamics of MD1003 (high-dose biotin) in the treatment of progressive multiple sclerosis, 2016; Expert Opinion on Drug.
  10. Fernandez-Mejia,  C. Journal of Nutritional Biochemistry 16 (2205) 424-427.
  11. Seaborg, E. January 2016: Thyroid Month: Beware of Biotin, Endocrine News, 2016. 
  12. Paxton A.  Beauty fad’s ugly downside: test interference.  CAP Today, September 20, 2016.

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