Clinical Communications: Biotin interference can cause false-negative specific IgE results in patients with anaphylaxis
Author: Nils Scheib, MSc, Daniel Bauersachs, MSc, Dimitrii Pogorelov, MD, Charlotte Mara Heinrich, AS, Feng Q. Hefeng, PhD, Carsten Bindslev-Jensen, MD, PhD, DMSci, Chrysanthi Skevaki, MD, Markus Ollert, MD, DMSci
The Journal of Allergy and Clinical Immunology: In Practice
Volume 10 Issue 9 Pages 2459-2462.e2 (September 2022)
NEW STUDY JUST PUBLISHED:
The study entitled, “Biotin interference can cause false-negative IgE test results in patients with anaphylaxis” was recently published in JACI In Practice. Researchers questioned if supplemental biotin intake (commonly used in over the counter for hair, nail and skin health) might impact serum specific IgE test results. It was concluded that testing patients who consume supplemental biotin with IMMULITE 2000 XPi Immunoassay System by Siemens, can cause false-negative test results possibly leading to misdiagnosis of severe allergies (anaphylaxis) to peanut, cashew nut and honeybee. NOVEOS does not have this limitation because of an innovative assay-design.
In the NOVEOS assay, the tested biotin concentrations had no effect on the 18 anaphylactic patients (Figure 2, A and F-H).
Figure 1: Biotin concentration-dependent interference in specific IgE (sIgE) immunoassays testing sera from patients sensitized to inhalant allergens. (A-F) Biotin-spiked sera were analyzed in parallel on three indicated immunoassays. (D-F) Green or blue digits represent the number of samples below the threshold of 0.35 or 0.1 kU/L. Sera were from patients with (D) lower, (E) intermediate, (F) or higher sIgE levels.
Figure 2: Biotin interference in specific IgE (sIgE) immunoassays testing sera of anaphylactic patients. (A) Percentage change of sIgE on IMMULITE-2000 and NOVEOS. (B-H) Green digits represent the number of false-negative sIgE values. (B-D) Cumulative distribution percentages for varying sIgE cutoff values measured by IMMULITE-2000 within each indicated allergen group. Diagnostic threshold, 0.35 kU/L. P was determined by a linear mixed model (∗∗∗P ≤ .001, lmer from R).
Figure 3: Biotin interference with specific IgE (sIgE) readout using the IMMULITE2000 assay for each inhalant allergen extract. Sera were spiked with various concentrations of biotin before measurement ([A] D1, n = 3; [B] E1, n = 3; [C] G6, n = 2; [D] M6, n = 3; and [E] T7, n = 3). Green or blue digits represent the number of samples below the threshold of 0.35 or 0.1 kU/L.