Biotin Supplementation and Possible Interference with Specific Laboratory Tests
The Food and Drug Administration has recently published a warning regarding the possible interference of biotin supplementation with specific laboratory tests. While only a few types of biological tests are affected, the potential ramifications of erroneous test results for patients’ health outcomes are non-negligible. Laboratories are currently working on using alternative tests to avoid this issue.
What is the issue?
Biotin-based immunoassays (using biotin-streptavidin technology) are typically used for the evaluation of endocrine function, as well as for other tests such as troponin, serum folate, vitamin D, hepatitis A & B antibodies, and others. Some of these tests are at risk of producing falsely decreased or increased results when biotin is present in the tested sample. Depending on the test method, biotin concentrations in biological samples as low as 8.6 ng/mL could trigger a difference greater than +/-10% in test results.1,2
What recommendations should you make for your patients?
Biotin has a short half-life of approximately 2 hours, so recommending that they stop taking biotin at least 8 hours before a blood test may be sufficient to minimize interference. However, it is highly recommended that patients taking high doses of biotin abstain for 72 hours before having blood specimens drawn for laboratory tests.
Also remind your patients that if they need to have a blood test done in an emergency situation, it is important to inform the medical team in charge if they have taken biotin in the days preceding the test, especially if the dose of biotin is high.
Regardless, it is always good to remind your patients to list all medications and supplements they are taking when they are getting laboratory tests done.
At what doses can biotin interfere with laboratory tests?
According to the FDA, biotin intakes higher than the recommended daily allowance may cause interference with laboratory tests. For reference, the average daily recommended amounts for biotin is 30 mcg for adults.
Protocol For Life Balance® has several products containing biotin with a serving size of over 30 mcg/day:
Nutri-Dose™ B-12 (P0453 and P0455)
Ortho Multi™ Softgels for Women
Is there a list of test methods that are known to be impacted by biotin intakes?
Yes, the FDA has established a list of test methods know to be impacted by biotin intakes. This list is available at: https://www.fda.gov/medical-devices/vitro-diagnostics/biotin-interference-troponin-lab-tests-assays-subject-biotin-interference
As a practitioner, what should I do if I suspect there is interference with biotin and a laboratory test for one of my patients?
According to the FDA, if you suspect a problem with a laboratory test for a patient taking biotin that was responsible for the occurrence of adverse events, you are encouraged to report the adverse event(s) to the lab test manufacturer and the FDA.
Where can patients find more information about biotin?
The National Institutes for Health provides reliable information about biotin and potential interference with lab tests.