Abstract

The United States Food and Drug Administration issued a warning concerning biotin interference in clinical laboratory testing because of the growing number of adverse events. Many blood-based laboratory tests are immunoassays that exploit the strong binding between biotin and streptavidin. Normally, biotin concentrations in blood samples are too low to cause test interference (1). However, consumption of biotin as a vitamin supplement or high-dose therapy can interfere in many immunoassay designs due to the unnaturally high concentrations of biotin present in blood. For example, 10 mg of biotin supplement is 333-fold higher than the daily recommended …

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