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Validation of the analytical performance of the NOVEOS™ System, a system which improves upon the third-generation in vitro allergy testing technology.
Clin Chem Lab Med. 2020 Jun 05 [Online ahead of print]CC

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.

Authors+Show Affiliations

Institute of Laboratory Medicine, Universities of Giessen and Marburg Lung Center (UGMLC), Philipps University Marburg, German Center for Lung Research (DZL), Marburg, Germany.Department of Pediatric Pulmonology, Immunology and Intensive Care Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.Institute of Laboratory Medicine, Universities of Giessen and Marburg Lung Center (UGMLC), Philipps University Marburg, German Center for Lung Research (DZL), Marburg, Germany.Institute of Laboratory Medicine, Universities of Giessen and Marburg Lung Center (UGMLC), Philipps University Marburg, German Center for Lung Research (DZL), Marburg, Germany.Department of Pediatric Pulmonology, Immunology and Intensive Care Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.Institute of Laboratory Medicine, Universities of Giessen and Marburg Lung Center (UGMLC), Philipps University Marburg, German Center for Lung Research (DZL), Marburg, Germany. Institute of Laboratory Medicine and Pathobiochemistry, Molecular Diagnostics, Philipps-University Marburg, University Hospital Giessen and Marburg GmbH, Baldingerstraβe, 35043 Marburg, Germany, Phone: +4964212821443, Fax: +4964215865594.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32549134

Citation

Bauersachs, Daniel, et al. "Validation of the Analytical Performance of the NOVEOS™ System, a System Which Improves Upon the Third-generation in Vitro Allergy Testing Technology." Clinical Chemistry and Laboratory Medicine, 2020.
Bauersachs D, Potapova E, Renz H, et al. Validation of the analytical performance of the NOVEOS™ System, a system which improves upon the third-generation in vitro allergy testing technology. Clin Chem Lab Med. 2020.
Bauersachs, D., Potapova, E., Renz, H., Benes, S. H., Matricardi, P. M., & Skevaki, C. (2020). Validation of the analytical performance of the NOVEOS™ System, a system which improves upon the third-generation in vitro allergy testing technology. Clinical Chemistry and Laboratory Medicine. https://doi.org/10.1515/cclm-2020-0535
Bauersachs D, et al. Validation of the Analytical Performance of the NOVEOS™ System, a System Which Improves Upon the Third-generation in Vitro Allergy Testing Technology. Clin Chem Lab Med. 2020 Jun 5; PubMed PMID: 32549134.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Validation of the analytical performance of the NOVEOS™ System, a system which improves upon the third-generation in vitro allergy testing technology. AU - Bauersachs,Daniel, AU - Potapova,Ekaterina, AU - Renz,Harald, AU - Benes,Stephanie Hagner, AU - Matricardi,Paolo Maria, AU - Skevaki,Chrysanthi, Y1 - 2020/06/05/ PY - 2020/04/17/received PY - 2020/05/13/accepted PY - 2020/6/19/entrez KW - NOVEOS KW - allergen-specific immunoglobulin E KW - chemiluminescent enzyme immunoassay KW - in vitro diagnostics KW - microparticle KW - verification JF - Clinical chemistry and laboratory medicine JO - Clin. Chem. Lab. Med. N2 - 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. SN - 1437-4331 UR - https://www.unboundmedicine.com/medline/citation/32549134/Validation_of_the_analytical_performance_of_the_NOVEOS™_System,_a_system_which_improves_upon_the_third-generation_in_vitro_allergy_testing_technology L2 - https://www.degruyter.com/doi/10.1515/cclm-2020-0535 DB - PRIME DP - Unbound Medicine ER -
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