Compliance & Safety

Biotin Alert

Biotin is widely used in immunoassay type laboratory methods over a wide range of instruments at numerous clinical laboratories throughout the world (including Spectrum Health).

With the expansion of biotin – also known as vitamin B7 – supplementation and treatments (“over the counter” and prescription, respectively); an associated interference with many clinical laboratory tests has been identified, confirmed and documented. Unfortunately, magnitude and type (falsely increased/decreased) of interference varies with dose and assay; however, it has been confirmed that as dose increases so does the magnitude of the response. In late November 2017, the Food and Drug Administration (FDA) published a safety alert warning that biotin can interfere with certain lab tests and cause incorrect test results.

Spectrum Health Regional Laboratory and the Regional Hospital Laboratories strongly recommends that patients scheduled for ANY LAB TEST; abstain from anything listing biotin as an ingredient such as, but not limited to, vitamins, multivitamins, dietary supplements, drinks and cosmetic (hair, skin, nail etc) for at least 12 hours prior to testing. 

Patients receiving prescription biotin treatment (e.g. inherited biotin deficiency disorders, basal ganglia disorders and multiple sclerosis (experimental)) need to have their results reviewed in light of the treatment.

It is also recommended that providers evaluate their patients for biotin interference if lab results are inconsistent with clinical presentation.

Questions may be directed to Dr. David Alter using the “Contact Us” link above.

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