Analytical performance of the NOVEOS immunoassay for detection of allergen-specific IgE to M006 Alternaria alternata) to aid in the diagnosis of allergic diseases.
R. Salgado, B. Braddock, A. Cruz-Campos, S. Yith, E. Kieu, S. S. Bryant, A. Wang.
HYCOR Biomedical, Garden Grove, CA
Introduction: Allergic reactions are a result of the immune systems hyper reactive response to genetic or environmental triggers. These allergic responses are mediated by Immunoglobulin E (IgE) which serve a pivotal role in diagnosing specific allergies. The fully-automated and innovative NOVEOS immunoassay instrument utilizes chemiluminescent, paramagnetic micro-particle technology, and a 4µL sample per test to aid in diagnosing allergic diseases. We demonstrate the analytical performance of the new NOVEOS specific IgE (sIgE) test for detection of sensitivity to M006 (Alternaria alternata) allergen in this study.
Methods: The NOVEOS instrument precision and functional sensitivity was assessed over 20-days per CLSI EP15-A3/CLSI EP05-A3 and CLSI EP17-A2/CLSI EP05-A3, respectively. Diagnostic and relative agreement was evaluated in accordance with CLSI EP12-A2. Method comparison between NOVEOS System and another device was conducted in accordance with CLSI EP09C. Limit of Blank (LoB) and Limit of Detection (LoD) were completed per CLSI EP17-A2 by testing multiple instruments. Carryover was also established by testing on multiple instruments per CLSI I/LA20-A3. The linearity assessment included multiple serial dilutions at different concentrations and was assessed per CLSI I/LA20-A3. In addition, the following studies were evaluated using the paired-difference design in alignment with CLSI I/LA20-A3: interference, competitive inhibition, and cross reactivity against the non-IgE immunoglobulin classes. Results: The NOVEOS sIgE test for M006 (Alternaria alternata) showed good repeatability and within-lab precision across 20-days with < 10%CV and < 12%CV, respectively; functional sensitivity was determined to be less than 0.35kU/L. In addition, LoB, LoD and carryover were found to be less than 0.10kU/L across multiple instruments. The NOVEOS sIgE assay also demonstrated a strong correlation when compared to clinical findings, confirmed by skin prick test, and another commercially available device. The assay also exhibited good linear regression over multiple concentrations. Lastly, interference (endogenous and exogenous substances, including biotin), cross-reactivity and competitive inhibition were found to have minimal or no impact to the NOVEOS sIgE performance.
Conclusion: The NOVEOS immunoassay for detection of allergen-specific IgE for M006 (Alternaria alternata), demonstrated a strong analytical performance to aid in the diagnosis of allergic diseases.