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Clinical Agreement and Method Comparison of the NOVEOS and ImmunoCAP Specific IgE Assays

Updated: Apr 28, 2022

Clinical Agreement and Method Comparison of the NOVEOS™ and ImmunoCAP™ Specific IgE

Assays Using Allergens G002 (Bermuda Grass, C. dactylon), G005 (Rye Grass, L. perenne) G006

(Timothy Grass, P.pratense), G010 (Johnson Grass, S. halepense)*

Yith S., Kieu E., Cruz-Campos A., Braddock B., Bryant S., Salgado R., Wang A.

Introduction: The NOVEOS™ Specific IgE (sIgE) assay utilizes paramagnetic microparticles as the

solid phase to capture allergen IgE antibodies; the chemistry demonstrates good sensitivity and

accuracy in measuring IgE in human serum. The results of NOVEOS in vitro testing serve as an

aid in the diagnosis of allergy associated disease and can supplement results observed for Skin

Prick Testing (SPT) 1 . In order to demonstrate the accuracy for NOVEOS allergen-specific IgE,

comparison studies between the ImmunoCAP™ sIgE assay and NOVEOS sIgE were assessed.

Four grass allergens were used for this comparative study: G002 (Bermuda Grass, C. dactylon),

G005 (Rye Grass, L. perenne) G006 (Timothy Grass, P. pratense), G010 (Johnson Grass, S.


Methods: The agreement of the NOVEOS sIgE assay was evaluated using clinical samples with

known SPT results in accordance with CLSI EP12. In addition, a relative comparison study

between the NOVEOS and ImmunoCAP specific IgE (sIgE) assays was conducted according to

CLSI EP09-A3 guidelines using more than 220 samples from anonymous donors. Finally, the

normal range of the assay was evaluated in accordance with CLSI EP28-A3C.

Results: Clinical sensitivity and specificity for the four grass allergens exhibited a range of 58.8%

- 88.2% and 95.9% - 99.2%, respectively. The relative agreement in sensitivity to ImmunoCAP

was 83.3% - 95.7%, whereas the relative agreement in specificity was 96.0% - 99.2%. The

quantitative comparison between the NOVEOS and ImmunoCAP sIgE assays showed linear

regression slopes ranging from 0.60 to 1.34 and correlations (r) between 0.845 and 0.955. The

normal range for the NOVEOS sIgE assay is <0.35 kU/L for all four allergens assessed.

Conclusion: The NOVEOS sIgE assay demonstrates good agreement with clinical status, and

comparable results to ImmunoCAP sIgE assay for the four grass allergens examined.

1. Homburger, H. A. & Adkinson, N. F. Diagnosis of Allergy: In Vitro Testing. CRC Critical Reviews

in Clinical Laboratory Sciences 23, 279–314 (1986).

* NOVEOS Immunoassay Analyzer and sIgE allergens presented are CE Marked. G002, G005,

G006, G010 are forg Investigational Use Only pending U.S. 510(k) submission and clearance.


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