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

Abstract

<jats:title>Abstract</jats:title><jats:sec id="j_cclm-2020-0535_s_999_w2aab3b7b1b1b6b1aab1c12b1Aa"><jats:title>Objectives</jats:title><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>®</jats:sup> 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.</jats:p></jats:sec><jats:sec id="j_cclm-2020-0535_s_998_w2aab3b7b1b1b6b1aab1c12b2Aa"><jats:title>Methods</jats:title><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></jats:sec><jats:sec id="j_cclm-2020-0535_s_997_w2aab3b7b1b1b6b1aab1c12b3Aa"><jats:title>Results</jats:title><jats:p>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 &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></jats:sec><jats:sec id="j_cclm-2020-0535_s_996_w2aab3b7b1b1b6b1aab1c12b4Aa"><jats:title>Conclusions</jats:title><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’ design and performance.</jats:p></jats:sec>

Validation study of a new chemiluminescent singleplex IgE assay in a set of Italian allergic rhinitis patients

“…This was not surprising since the recombinant allergen molecules have a defined purity and biological activity 26 . In a preliminary study, 21 we had found that the NOVEOS test is a robust one, as it achieved good results in all the required parameters of the clinical validation performed at 2 sites. Concerning repeatability, it yielded a coefficient of variation of 2.6%–7.6%, and within‐lab precision ranged from 3% to 11.9%.…”

“…Interference was tested with methylprednisolone, diphenhydramine, omalizumab, biotin and ranitidine, and the obtained IgE recovery values were within the accepted variation. A comparison between the new systems' calibrators and the World Health Organization ones indicated a linear correlation with a high correlation coefficient of r = 0.994 and r = 0.997 for the 2 sites 21 …”

“…This was not surprising since the recombinant allergen molecules have a defined purity and biological activity. 26 In a preliminary study, 21 results that have a moderate discordance level for the cypress allergen, with CAP providing a higher result than NOVEOS.…”

“…20 The NOVEOS System and specific IgE assay from HYCOR are novel in that they offer, among other advantages, a significantly lower (1/10th) sample volume per test in comparison with ImmunoCAP, and a robust chemistry design of chemiluminescence, fluorescence and paramagnetic microparticles which contribute to good precision and accuracy. 21 The assay design appears unaffected by known sample-related interferences including biotin, IgG, IgG4 and cross-reactivity by anti-carbohydrate determinants (CCD) antibodies that react with other cellulose-based technologies. [22][23][24] The aim of this study is to test, in comparison with ImmunoCAP, the analytical performance of the NOVEOS sIgE tests used in routine procedures.…”

A singleplex IgE test to a mixture of molecules from multiple airborne allergen sources: Innovating in vitro screening of respiratory allergies

“…The molecular SX01 test adopts a chemiluminescence detection system (NOVEOS, Hycor, USA) operating in a solid phase of fluorescently labeled and streptavidin-coated paramagnetic microparticles, already described elsewhere. 22 The microparticles are first incubated with a biotinylated allergen that binds the streptavidin molecules. After an extensive wash, the bound microparticles are then incubated with patient serum containing allergen-specific IgE, and the resulting bound complex is washed by aspirating unbound material from retained beads in the cuvette.…”