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AACC Issues Guidance on Biotin Interference in Lab Tests

NEW YORK – The American Association for Clinical Chemistry has issued a guidance instructing clinicians, lab professionals, and patients how to prevent biotin from interfering with test results.

The guidance highlights the need for good communication between clinicians and labs to ensure doctors and patients understand what tests might be affected by patient biotin use and to keep labs informed about patients' biotin intake. It follows recommendations issued by the US Food and Drug Administration in November 2019.

Biotin is a key component of many immunoassays, but it has also become commonly used in products like beauty supplements and multivitamins as well as in certain drugs. According to the AACC, at least 20 percent of Americans take biotin in some form, and this intake can interfere with the results of certain clinical tests.

The AACC guidance instructs clinicians to inform labs if a patient has taken a dose of biotin larger than 5 mg and to consider biotin interference when test results don't match patient symptoms. Additionally, it calls for labs to use tests without biotin for samples suspected of containing biotin. In cases when this is not possible, patients should abstain from biotin for eight to 72 hours before giving blood for testing.

"The recent increase in the use of high-dose biotin supplements requires that laboratorians and clinicians be mindful of the potential for biotin interference in biotinylated immunoassay-based laboratory tests," said the guidance document authors Danni Li, Angela Ferguson, Mark Cervinski, Kara Lynch, and Patrick Kyle in a statement. "Ideally, manufacturers will reformulate assays that are sensitive to biotin. Given that the timeline from initial assay design to reformulation and governmental approval requires months to years, laboratorians and clinicians will have to remain mindful of this issue for some time to come … [and] should work together to ensure accurate laboratory results."