Abstract

Certain immunoassays used in clinical laboratories utilized biotin-streptavidin interaction in assay design. These assays utilize biotinylated antibodies, and if biotin is present in high concentrations in the specimen, it may interfere with test results. Biotin is known to cause positive interference (falsely elevated analyte value) in competitive immunoassays but negative interference (falsely lower analyte value) in sandwich immunoassays. In general, competitive immunoassays are used for analysis of small molecules such as therapeutic drugs and thyroxine, while the sandwich format is used for analysis of large molecules such as proteins and hormones. Normal biotin concentration in serum is very low and has no effect on biotin-based immunoassays. Taking multivitamins that usually contain 30μg biotin or taking biotin supplement of less than 2.5mg per day has no effect on biotin-based assays. Usually interference is observed with a biotin dose of 5mg or higher depending on individual assay but a serum biotin level >500ng/mL is known to interfere with all biotin-based assays. However, such high biotin concentration is only observed in people taking 100–300mg biotin/per day. The most commonly reported problem with biotin interference is wrong diagnosis of hyperthyroidism due to falsely lower thyroid-stimulating hormone value but falsely elevated free thyroxine and free triiodothyronine values. A serious problem is missed diagnosis of myocardial infarction due to falsely lower troponin I or troponin T levels in a person taking high-dose biotin supplement.

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