Abstract
The use of high concentrations of biotin as a dietary supplement to improve hair, skin, and nail quality has increased in the United States over the past few years. High concentrations of biotin have been shown to interfere with some diagnostic assays that use streptavidin–biotin interactions as one of the steps in the assay. The objective of this report is to evaluate potential biotin interference on the analytical and clinical sensitivity of a point of care (POC) antigen–antibody combo HIV-1 assay. We spiked biotin at concentrations ranging from 12.5 to 400 ng/mL into serum and plasma containing HIV-1 subtype B p24 antigen derived from culture supernatant. The p24 antigen was present in the matrices at 30 pg/mL. Fifty microliters of each sample was applied to Alere Determine HIV-1/2 Ag/Ab combo assay strips in duplicate and results were read by eye after 20 to 30 min. Biotin interfered with detection of HIV-1 p24 in serum and plasma. HIV-1 p24 was not detected at 30 pg/mL p24 when biotin was present at 200 ng/mL concentration. Our study demonstrated that elevated levels of biotin in samples may interfere with POC assays. It is important to consider biotin supplements as potential sources of falsely increased or decreased test results, especially in cases wherein supplementation cannot be ruled out.
Highlights
Biotin–streptavidin interactions are the strongest known noncovalent biological interactions, with a femtomolar range dissociation constant and an interaction that is resilient to temperature and pH changes.[1]
HIV-1 p24 was not detected at 30 pg/mL p24 when biotin was present at 200 ng/mL concentration
We focused on HIV-1 p24 in our study, which is the antigen component in antibody–antigen assays, called combination, or combo assays
Summary
Biotin–streptavidin interactions are the strongest known noncovalent biological interactions, with a femtomolar range dissociation constant and an interaction that is resilient to temperature and pH changes.[1] Biotin is used together with streptavidin in the design of many diagnostic assays, leveraging the high stability and specificity of the interactions to increase analytical sensitivity.[2] In some designs, immobilized streptavidin (e.g., on a bead or membrane) is used to capture a biotin-labeled analyte. The stable biotin label on an analyte is small and rarely interferes with the function of labeled molecules, enabling the streptavidin–biotin interaction to be used for development of robust and highly sensitive assays. Assays that use biotin–streptavidin chemistry to capture and evaluate an analyte may be susceptible to interference from free excess biotin in a sample if it competes with the biotin-labeled analyte for binding to streptavidin. Normal intake of biotin at the daily recommended dietary allowance of 30 lg/day (123 nmol/ day) from food rarely interferes with assay results.[3]
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