By Victor Leung, Dana Nyholt-Bailey, IQMH Endocrinology and Immunology Scientific Committee and Staff
Recent years have seen a significant increase in the number of cases of biotin interference with streptavidin-biotin (SB)-based immunoassays reported in the literature. Biotin interference with laboratory tests, specifically SB-based immunoassays, is potentially dangerous, as it may cause spurious test results leading to misdiagnosis and patient mismanagement.
The U.S. Food and Drug Administration (FDA) recently reported increased adverse events related to biotin interference of SB-dependent immunoassays including a falsely low troponin and subsequent death1, whereas Health Canada has published at least nine Recalls & Safety Alerts since 2017 related to biotin interference of lab tests in commonly used clinical analyzers.2 Most commonly are those associated with inaccurate thyroid hormone or PTH quantitation; most significantly are those associated with deaths including false-negative troponin. Less commonly reported are interferences impacting pregnancy testing or infectious disease serology. These public reports clearly demonstrate an urgent need to address the issues pertaining to biotin interference.
What is biotin?