Biotin Interference in Point of Care HIV Immunoassay

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.

Natural Hair Supplements: Biotin and Collagen

“…Although a balanced nutritional diet provides sufficient biotin to support healthy and strong hair growth, the addition of biotin supplements is generally considered safe. Daily doses of more than 5,000 mcg do not provide additional benefits and can interfere with the results of diagnostic laboratory testing (Setty et al, 2020).…”

“…To prevent the effect that biotin may have on laboratory tests, patients who have taken 5,000–10,000 mcg of biotin should wait 8–12 hr before having their blood collected for laboratory tests (Grimsey et al, 2017). If the patient is taking less than 5,000 mcg per day, this is not as much of a concern (Grimsey et al, 2017; Setty et al, 2020). Surprisingly, despite announcements from the FDA, approximately 1 in 5 physicians (19.5%) are unaware of the potential interference of biotin with laboratory results (Falotico & Lipner, 2022).…”

“…Specifically, the FDA reported that circulating biotin levels of 1,200 ng/mL can interfere with troponin assays and produce a false-negative result for heart attack. Other biomarkers that may be affected include 25-OH vitamin D, human chorionic gonadotropin, thyroid hormones, hepatitis, or HIV tests (FDA, 2022; Setty et al, 2020). Based on the type of assay, the effect can be an artificial increase or decrease (Li et al, 2020).…”

Lateral flow assays for viruses diagnosis: Up-to-date technology and future prospects

“…Similarly, Dengue NS1 can be cited as an example. Because false-positive results for this dengue biomarker have been reported in patients with acute zika infection, caution should be exercised when interpreting dengue NS1 results [ 182 ]. A group of researchers has shown that the combined use of Dengue NS1 and antibodies (IgM and IgG) improves diagnosis rates for dengue fever [ 183 , 184 ].…”

“…It is also an important marker of choice for predicting CD4 + [ 112 ]. However, it is also known that high concentrations of biotin prevent the detection of HIV-1 p24 antigen in serum [ 113 ]. This significantly reduces the specificity of the tests.…”