The prevalence of elevated biotin in patient cohorts presenting for routine endocrinology, sepsis, and infectious disease testing

Elevated blood biotin levels may interfere with some biotin-streptavidin immunoassays, used in clinical laboratories to aid diagnosis. The objective of this study was to determine the prevalence of elevated blood biotin levels in three at risk patient cohorts, where misclassification of disease status would have a high clinical impact. This retrospective, single-center study screened residual, de-identified plasma samples (N = 700) from adult patients undergoing routine thyroid stimulating hormone (TSH) (n = 500), procalcitonin (PCT) (n = 100), or human immunodeficiency virus (HIV) (n = 100) testing using the Elecsys (R) BRAHMS PCT (Roche Diagnostics), Access TSH (3rd IS) (Beckman Coulter Inc), and ARCHITECT HIV Ag/Ab Combo (Abbott Laboratories) immunoassays, respectively, for elevated levels of biotin (quantified by gas chromatography-time of flight mass spectrometry). Patients taking biotin supplements were included and dosages recorded from medical records. In the overall study cohort, blood biotin levels ranged 0.1-21.3 ng/mL; 44.3% (310/700) of samples were < 1 ng/ mL, 54.7% (383/700) were 1- 10 ng/mL, and 1% (7/700) were 10 ng/mL, and 11.4% (5/44) were 10 ng/mL. Most patients who reported taking biotin supplements had blood biotin levels > 1 ng/mL and the highest blood biotin level detected was 21.3 ng/mL.