{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,18]],"date-time":"2026-04-18T02:36:52Z","timestamp":1776479812792,"version":"3.51.2"},"reference-count":25,"publisher":"Walter de Gruyter GmbH","issue":"11","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,10,25]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec id=\"j_cclm-2020-0535_s_999\">\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>Detection of allergen-specific immunoglobulin E (sIgE) is important for the diagnosis of allergy. IgE sensitization is commonly demonstrated <jats:italic>in vivo<\/jats:italic> by skin prick testing (SPT), or <jats:italic>in vitro<\/jats:italic> utilizing automated systems. Recently, HYCOR<jats:sup>\u00ae<\/jats:sup> Biomedical launched its new system for allergen sIgE testing called the NOVEOS\u2122 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 Charit\u00e9 Medical University Berlin (Site-2), respectively.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2020-0535_s_998\">\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>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).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2020-0535_s_997\">\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The conducted repeatability and within-laboratory precision tests provided acceptable performance with 3.0%\u201311.9% coefficient of variation across both sites. The limit of blank (LoB) and limit of detection (LoD) were &lt;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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2020-0535_s_996\">\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>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 &lt;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\u2019 design and performance.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1515\/cclm-2020-0535","type":"journal-article","created":{"date-parts":[[2020,6,8]],"date-time":"2020-06-08T11:12:46Z","timestamp":1591614766000},"page":"1865-1874","source":"Crossref","is-referenced-by-count":11,"title":["Validation of the analytical performance of the NOVEOS\u2122 System, a system which improves upon the third-generation <i>in vitro<\/i> allergy testing technology"],"prefix":"10.1515","volume":"58","author":[{"given":"Daniel","family":"Bauersachs","sequence":"first","affiliation":[{"name":"Institute of Laboratory Medicine, Universities of Giessen and Marburg Lung Center (UGMLC) , Philipps University Marburg, German Center for Lung Research (DZL) , Marburg , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ekaterina","family":"Potapova","sequence":"additional","affiliation":[{"name":"Department of Pediatric Pulmonology, Immunology and Intensive Care Medicine , Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin , Berlin , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Harald","family":"Renz","sequence":"additional","affiliation":[{"name":"Institute of Laboratory Medicine, Universities of Giessen and Marburg Lung Center (UGMLC) , Philipps University Marburg, German Center for Lung Research (DZL) , Marburg , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephanie Hagner","family":"Benes","sequence":"additional","affiliation":[{"name":"Institute of Laboratory Medicine, Universities of Giessen and Marburg Lung Center (UGMLC) , Philipps University Marburg, German Center for Lung Research (DZL) , Marburg , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paolo Maria","family":"Matricardi","sequence":"additional","affiliation":[{"name":"Department of Pediatric Pulmonology, Immunology and Intensive Care Medicine , Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin , Berlin , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chrysanthi","family":"Skevaki","sequence":"additional","affiliation":[{"name":"Institute of Laboratory Medicine, Universities of Giessen and Marburg Lung Center (UGMLC) , Philipps University Marburg, German Center for Lung Research (DZL) , Marburg , Germany"},{"name":"Institute of Laboratory Medicine and Pathobiochemistry, Molecular Diagnostics , Philipps-University Marburg, University Hospital Giessen and Marburg GmbH , Baldingerstra\u00dfe , 35043 Marburg , Germany , Phone: +4964212821443, Fax: +4964215865594"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"374","published-online":{"date-parts":[[2020,6,5]]},"reference":[{"key":"2023033110392394437_j_cclm-2020-0535_ref_001","doi-asserted-by":"crossref","unstructured":"Meyer R, Fox AT, Chebar Lozinsky A, Michaelis LJ, Shah N. 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