Validation of a Commercial Reagent for the Depletion of Biotin from Serum/Plasma: A Rapid and Simple Tool to Detect Biotin Interference with Immunoassay Testing

Abstract

Background: It is important for clinical laboratories to have protocols for investigating suspected biotin interference in patient samples. VeraPrep Biotin™ is a commercial product used to rapidly deplete biotin from serum/plasma samples. The objectives of this study were to verify that VeraPrep Biotin™: (a) does not impact immunoassay analyte recovery in control samples and (b) can effectively deplete biotin from samples (both biotin-spiked and samples from donors who ingested biotin supplements). Methods: De-identified residual waste serum/plasma samples were combined to create 9 pools for each immunoassay. Plasma/serum samples (n = 23) were obtained from 6 healthy donors at varying times following ingestion of biotin (20 mg, 100 mg, or 200 mg). Nine Elecsys immunoassays were evaluated using the e 602 (Roche Diagnostics Inc.). Control, biotin-spiked (n = 10, ∼400 ng/mL), and donor samples were assayed pre- and post-VeraPrep treatment. Percentage analyte recovery [(posttreatment/pretreatment) × 100] was calculated for control samples. A laboratory-developed LC-MS/MS method was used to quantify biotin. Results: In control samples (n = 81), 90-110% analyte recovery was observed post-VeraPrep treatment in over 95% of samples (77/81). The pre- and post-VeraPrep treatment biotin concentration [mean ± standard deviation (SD)] for specimens spiked with up to 500 ng/mL biotin was 357 ± 47 ng/mL and 1.0 ± 0.6 ng/mL, respectively. The mean (range) biotin concentration for the donor samples pre- and post-treatment was 166 (15-1029) ng/mL and 0.2 (<0.1-3) ng/mL, respectively (P = 0.004). Conclusions: These data demonstrate that treatment with VeraPrep Biotin™ does not affect analyte recovery in biotin-negative samples and effectively depletes both spiked and endogenous biotin in serum/plasma.