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For IVD manufacturers, FDA issues new draft guidance document on Biotin interference.


Author: Alex Chang


Biotin (or vitamin B7) is a water-soluble B-complex that helps metabolize proteins, fats and carbohydrates and to process glucose. The human body cannot synthesize biotin and as such it needs to be supplied in your diet. Since it aids in processing glucose, researchers believe that it plays a part in controlling diabetes. Biotin also contributes to healthy nails, skin and hair and as such, biotin supplements have been used frequently aesthetically. As I am a "man of certain age" or approaching that age, biotin supplements sounds like a great idea to stay looking rejuvenated.


Back in November 2017, the FDA warned that high doses of biotin can interfere with hundreds of common lab tests, such as TSH and troponin. Many of these tests use biotin technology due to its ability to bond with specific proteins which can be measured to detect certain health conditions, therefore having the potential to interfere with the results. Too much biotin in lab tests for thyroid hormones can lead doctors to misdiagnose Grave’s disease in children and adults. There was one incidence where one patient died from a heart attack after a blood test showed falsely low levels of troponin. The Institute of Medicine recommends that people get 0.03 mg of biotin daily, however some supplement contain 30 mg which is 650 times more than the recommended intake.


Patients and physicians may be unaware of biotin interference in lab tests and patients may not be disclosing the use of biotin products when ordering tests. The onus is on the IVD manufacturers need to make sure that biotin interference is considered when developing their diagnostic tests.


FDA has issued a draft guidance document for commenting entitled “Testing for Biotin Interference in In Vitro Diagnostic Devices”. It simply recommended the following to IVD Manufacturers:

  • Consistent with the recommendations in the CLSI standard, concentrations of biotin that reflect current trends in biotin consumption should be evaluated, up to 3500 ng/mL.

  • The test samples should include analyte levels near the medical decision point(s) of the device.

  • For assays that are susceptible to biotin interference at concentrations less than 3500 ng/mL, the concentration of biotin at which no interference is detected should be determined.

  • The results of the testing should be communicated to end-users, including clinical laboratories and clinicians. Therefore, information on biotin interference should be included in the labeling1 of the device, including the percent difference or bias at each concentration tested for both qualitative and quantitative assays and the consequence of biotin interference (e.g., falsely elevated, falsely depressed), if observed.

What’s not stated in the guidance document is that the potential for false positives and false negatives resulting from high levels of biotin should also be captured in your risk management documents.


References:

  1. Nordqvist, C. (last updated 07 Feb 2017) ‘Why do we need biotin, or Vitamin B7?” retrieved from: https://www.medicalnewstoday.com/articles/219718.php

  2. “The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication” retrieved from: https://www.fda.gov/medical-devices/safety-communications/fda-warns-biotin-may-interfere-lab-tests-fda-safety-communication; last accessed: 18 June 2019.

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