NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg

The NOVEOS Specific IgE (sIgE) assay is an in vitro quantitative immunoassay for measuring allergen-specific IgE antibodies in human serum to aid in diagnosing IgE-mediated allergic disorders. It uses four specific allergen capture reagents (peanut, milk proteins alpha-lactalbumin and beta-lactoglobulin, and egg ovalbumin) and runs on the NOVEOS Immunoassay Analyzer in clinical laboratory settings.

The NOVEOS assay uses fluorescence-adjusted, immunometric chemiluminescence detection with magnetic microparticles as the solid phase, requires only 4 µL sample volume, and employs horseradish peroxidase-conjugated anti-human IgE antibody for detection. It differs from the ImmunoCAP predicate, which uses beta-galactosidase detection and requires 40 µL sample volume, but both systems use six calibrators with WHO-traceable standards and achieve comparable assay ranges of 0.10–100 kU/L.

Performance was validated using CLSI guidelines including EP05-A3 (precision evaluation), EP15-A3 (user verification of precision and bias), EP06-2nd Edition (linearity), EP07 (interference testing), EP17-A2 (detection capability), EP25-Ed2 (stability evaluation), EP28-A3c (reference intervals), and I/LA20-3rd Edition (immunological assay characteristics and analytical specificity).

The NOVEOS sIgE assay is substantially equivalent to the predicate ImmunoCAP Specific IgE (K051218) because both are automated quantitative immunoassays intended for the same clinical purpose (allergen-specific IgE measurement in serum for allergy diagnosis), measure the same allergens (peanut, milk components, egg), use identical calibration methods and WHO reference standards, and demonstrate equivalent clinical performance with sensitivity/specificity ≥79.3%/100% across all allergens tested.