WASHINGTON – Biotin’s upsurge in popularity has led to a parallel rise in incidents of this health supplement interfering with critical medical tests. A new guidance document from AACC urges clinicians and laboratory experts to collaborate to prevent this potentially harmful test interference, and to ensure that patients taking biotin receive high quality care.
In recent years, the danger of biotin interfering with laboratory tests has grown serious enough that the Food and Drug Administration issued two safety communications warning about this phenomenon—one of which just came out in November 2019. At least a fifth of Americans take biotin, either as a beauty supplement, as part of an over-the-counter multivitamin, or as a treatment for medical conditions such as multiple sclerosis. However, biotin is also a key ingredient in a clinical testing method known as the immunoassay, which labs use to detect a broad range of conditions, from heart failure and prostate cancer to thyroid disease and pregnancy. If a patient takes biotin supplements, the biotin in his or her blood sample competes with the biotin used in immunoassays and can falsely increase or decrease the results of these tests. This in turn can lead to inappropriate treatment and subsequent patient harm, and has so far caused one reported death.
AACC’s guidance document, developed by experts in the association’s Academy, gives recommendations to clinicians, laboratory medicine professionals, and patients about steps they can take to ensure that biotin does not interfere with crucial test results. First and foremost, the guidance emphasizes that open communication between laboratories and clinicians is key to tackling this problem. Labs should keep both clinicians and patients informed about which tests could be affected by biotin interference. Clinicians should also contact the lab if they know a patient has taken a dose of biotin >5 mg, as well as to see if biotin interference could be at play when test results don’t fit with a patient’s symptoms.
If a patient sample is suspected of containing biotin, ideally, the lab should analyze it with a testing method that does not use biotin as an ingredient. Because this isn’t always possible, though, labs can also request a new specimen after the patient has abstained from biotin. Unless medically contraindicated, AACC’s guidance recommends that patients abstain for a minimum of either 8 or 72 hours before blood collection, respectively, depending on whether they are taking a lower (5-10 mg/day) or high (≥100 mg/day) dose of biotin.
“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 Drs. Danni Li, Angela Ferguson, Mark A. Cervinski, Kara L. Lynch, and Patrick B. Kyle. “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.”
About AACC
Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.myadlm.org.