HYCOR White Papers
Biotin Interference in Allergy Testing
For clinical laboratories using 3G Allergy testing (i.e. use IMMULITE 2000/2500 instruments from Siemens)
The Pain Point:
False negative specific IgE results with patents taking moderate to high levels of biotin.
Take away points:
In non-competitive indirect assays like the NOVEOS assay (Figure 3), the biotinylated-protein is initially bound to the streptavidin-coated solid phase, followed by incubation with patient sample. Any biotin in the sample, therefore, does not compete for binding. (With the NOVEOS Specific IgE Assay, the streptavidin microparticles and biotinylated protein are coupled prior to the introduction of sample, removing any risk of biotin interfering with the assay).
IMMULITE 2000 Specific IgE Assay combines patient sera, biotinylated-protein, and a streptavidin bead in a single incubation step. If a patient’s sera contains excess biotin, this allows for the biotin to compete with the biotinylated protein and IgE for the limited surface available on the bead, which may result in a false negative or falsely diminished signal.
NOVEOS and ImmunoCAP specific IgE assays show minimal bias with all samples retaining their positive values (≥0.35 kU/L).IMMULITE 3G Allergy however showed significant bias and resulted in all samples reporting as negative (<0.35 kU/L).