Abstract
The biotin: streptavidin complex is an enduring feature of modern immunoassay design. Although offering distinct performance benefits, the Achilles' heel of such immunoassays is potential interference from high concentrations of exogenous biotin. Once rare, biotin interference is an increasingly reported cause of erroneous results, potentially leading to incorrect diagnosis and inappropriate therapy, or missed diagnosis and failure to adequately treat. This Chapter will outline the properties of biotin and streptavidin that underlie their near ubiquity in clinical diagnostics and biotechnology. It will also explore the pathophysiology of biotin in human health and disease, its therapeutic use, trends of supplementation in the general community, as well as newly reported pharmacokinetic findings. The history of biotin interference will be chronicled and its characteristic features described. Finally, the current options for risk mitigation will be explicated. The unique features of biotin as an interferent, coupled with the increased use of high dose biotin therapy, have significantly changed the risk profile of assays long in use and there is a clear need for active measures to prevent clinical harm.
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