NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz

The NOVEOS Specific IgE (sIgE) Assay is an in vitro quantitative immunoassay for measuring allergen-specific IgE antibodies in human serum. It is used with the NOVEOS Immunoassay Analyzer to aid in the clinical diagnosis of IgE-mediated allergic disorders in clinical laboratory settings. The assay includes eight capture reagents targeting common allergens: Johnson Grass, Oak, Bermuda Grass, Common Ragweed, Dog Dander, Common Silver Birch, Egg White, and Cow's Milk.

The NOVEOS assay employs a fluorescence-adjusted, immunometric chemiluminescent procedure using magnetic streptavidin-coated microparticles, compared to the predicate ImmunoCAP's fluoroenzyme-immunoassay with cellulose derivative solid phase. NOVEOS uses a 4 µL sample volume versus ImmunoCAP's 40 µL, and achieves results in 1 hour 45 minutes. Both use horseradish peroxidase or β-galactosidase conjugates respectively, six calibrators at identical levels, and are traceable to WHO reference reagent IgE 11/234.

CLSI guidelines: EP05-A3 (Precision), EP15-A3 (User Verification of Precision), EP06-2nd Edition (Linearity), EP07 (Interference Testing), EP17-A2 (Detection Capability), EP25-A2 (Stability), EP28-A3c (Reference Intervals), and I/LA20-3rd Edition (Immunological Assays for IgE). IEC 62304 Edition 1.1 for software life cycle and ISO 14971 Third Edition for risk management.

Substantial equivalence is established through clinical performance studies demonstrating comparable diagnostic sensitivity and specificity to ImmunoCAP across all eight allergens (e.g., G010 sensitivity 72.9% vs ImmunoCAP's historical 53%, specificity 99.2% vs 100%), method comparison studies showing 82.2–96.0% total agreement with ImmunoCAP, and comparable analytical performance including linearity (R² ≥0.987), precision (total CV 4.7–10.6%), and detection limits. Both devices perform the same quantitative measurement of allergen-specific IgE in serum using identical calibration methodology and cutoff values, with identical indications for use in clinical laboratories, supporting the finding that differences in solid phase, conjugate, and sample volume do not alter the fundamental diagnostic purpose or safety/effectiveness profile.