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Biotin interference in diagnostic tests

Posted on 28.02.2019

Following FDA and European Competent Authorities communications on possible biotin interference, the Pharmacovigilance Risk Assessment Committee (PRAC) of European Medicines Agency (EMA) has recently published a set of recommendations, such as to provide supplementary information and to highlight special warnings and precautions. The communication can be found here.

Biotin is a water-soluble vitamin B, also called vitamin B7 and is widely distributed in food, dietary supplements and medications. High-levels of ingested biotin can interfere with diagnostic tests which employ a biotin-streptavidin reaction, resulting in incorrect test results, which are easily overlooked, leading to wrong patient management decision.