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Licensed Unlicensed Requires Authentication Published by De Gruyter June 5, 2020

Validation of the analytical performance of the NOVEOS™ System, a system which improves upon the third-generation in vitro allergy testing technology

Daniel Bauersachs, Ekaterina Potapova, Harald Renz, Stephanie Hagner Benes, Paolo Maria Matricardi and Chrysanthi Skevaki

Abstract

Objectives

Detection of allergen-specific immunoglobulin E (sIgE) is important for the diagnosis of allergy. IgE sensitization is commonly demonstrated in vivo by skin prick testing (SPT), or in vitro utilizing automated systems. Recently, HYCOR® Biomedical launched its new system for allergen sIgE testing called the NOVEOS™ Immunoanalyzer. This study aims to evaluate the analytical performance of the NOVEOS system in a bi-center study at Philipps-University Marburg (Site-1) and Charité Medical University Berlin (Site-2), respectively.

Methods

The analytical performance was evaluated based on the guidelines I/LA20-A3, EP5-A3, EP17-A2, EP6-A, EP7-A3, and EP9-A3 of the Clinical and Laboratory Standards Institute (CLSI).

Results

The conducted repeatability and within-laboratory precision tests provided acceptable performance with 3.0%–11.9% coefficient of variation across both sites. The limit of blank (LoB) and limit of detection (LoD) were <0.1 kU/L at both centers. A within-parameter linearity for all tested allergens was reported at both sites. Of note, no significant interference was observed for high levels of biotin, methylprednisolone, diphenhydramine, omalizumab, or ranitidine. Method comparison between the NOVEOS calibration and the latest World Health Organization (WHO) reference standard showed good agreement at both sites.

Conclusions

The results from the analytical performance of the NOVEOS allergen sIgE assay and instrument testing at both sites were comparable. Overall, a good precision and linearity as well as a detection limit <0.1 kU/L were observed, with minimal impact of common interfering substances on patient recoveries. The NOVEOS is calibrated to the latest WHO reference standard and adds benefits like a small sample size and para-magnetic microparticles that improve upon third-generation allergen sIgE assays’ design and performance.

  1. Author contributions: HYCOR Biomedical, CS, and PM conceived the study and interpreted the data. Daniel Bauersachs and Ekaterina Potapova were involved in sample analysis and data collection. Daniel Bauersachs wrote the first draft of the manuscript. All authors edited, reviewed, and approved the final manuscript. All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  2. Research funding: CS and HR are supported by Universities Giessen and Marburg Lung Center (UGMLC), the German Center for Lung Research (DZL; 82DZL00502/A2 to HR), University Hospital Gießen and Marburg (UKGM) research funding according to article 2, section 3 cooperation agreement (to CS and HR), the Deutsche Forschungsgemeinschaft (DFG) (Funder Id: http://dx.doi.org/10.13039/501100001659) – funded – SFB 1021 (C04, to HR and CS), KFO309 (P10 to CS), and SK 317/1-1 (Project Nr 428518790) (to CS). PM is funded by the Deutsche Forschungsgemeinschaft (DFG; grant number MA 4740/2-1).

  3. Competing interests: For CS: Consultancy and research funding, Hycor Biomedical, Bencard Allergie, and Thermo Fisher Scientific; Research Funding, Mead Johnson Nutrition (MJN). The research of HR is supported by Mead Johnson Nutritional and Beckman Coulter. He receives speaker’s honorarium from Allergopharma, Novartis, Thermo Fisher, Danone, Mead Johnson Nutritional, and Bencard. Further, HR is consulting Bencard, and Secarna Pharmaceuticals (co-founder). PM is consultant for HYCOR Biomedical, Euroimmun, and Thermo Fisher Scientific, has received research funding from HYCOR Biomedical, Euroimmun, reagents for research from Thermo Fisher and HYCOR Biomedical, and speaker’s fees from Euroimmun, Thermo Fisher Scientific, Stallergenes-Greer, and HAL Allergy. The rest of the authors declare that they have no relevant conflict of interest. All other authors reported no conflicts of interest.

  4. Employment or leadership: None declared.

  5. Honorarium: None declared.

  6. Ethical approval: All samples, courtesy of HYCOR Biomedical, were collected under Institutional Review Board (IRB)-approved protocols. The study was conducted following the ethical principles identified in the Declaration of Helsinki.

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Received: 2020-04-17
Accepted: 2020-05-13
Published Online: 2020-06-05
Published in Print: 2020-10-25

©2020 Walter de Gruyter GmbH, Berlin/Boston

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