TY - JOUR
T1 - Validation study of a new chemiluminescent singleplex IgE assay in a set of Italian allergic rhinitis patients
AU - Potapova, Ekaterina
AU - Bauersachs, Daniel
AU - Villella, Valeria
AU - Meneguzzi, Giorgia
AU - Scala, Enrico
AU - Sfika, Ifigenia
AU - Tripodi, Salvatore
AU - Panetta, Valentina
AU - Dramburg, Stephanie
AU - Skevaki, Chrysanthi
AU - Matricardi, Paolo Maria
N1 - Funding Information:
This study was supported by HYCOR (number 89772798), and HYCOR also provided the instrument and the reagents required to complete the study. Open access funding enabled and organized by ProjektDEAL.
Funding Information:
PM Matricardi is funded by the Deutsche Forschungsgemeinschaft (DFG; grant number MA 4740/2‐1). He is also a consultant for HYCOR Biomedical, Euroimmun, Thermo Fisher Scientific, Novartis, has received research funding from HYCOR Biomedical, Euroimmun, reagents for research from Thermo Fisher Scientific and HYCOR Biomedical, and speaker's fees from Euroimmun, Thermo Fisher Scientific, Stallergenes‐Greer, HAL Allergy. C. Skevaki is a consultant and receives research funding from HYCOR Biomedical, Bencard Allergie and Thermo Fisher Scientific; receives research funding from Mead Johnson Nutrition (MJN). E. Scala is funded by the Italian Ministry of Health, Current Research Program 2018–2020. He is also a consultant for TFS and Stallergenes‐Greer and has received speaker's fees from Thermo Fisher Scientific. C. Skevaki is supported by the Universities Giessen and Marburg Lung Center (UGMLC), the German Center for Lung Research (DZL), University Hospital Giessen and Marburg (UKGM) research funding according to article 2, section 3 cooperation agreement, and the Deutsche Forschungsgemeinschaft (DFG)‐funded SFB 1021 (C04), KFO 309 (P10), and SK 317/1‐1 (Project number 428518790) as well as by the Foundation for Pathobiochemistry and Molecular Diagnostics. All remaining authors declared no conflicts of interest.
Publisher Copyright:
© 2020 The Authors. Clinical & Experimental Allergy published by John Wiley & Sons Ltd.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/11/10
Y1 - 2020/11/10
N2 - Background: The measurement of specific IgE to allergenic extracts and molecules in patients with allergic rhinitis (AR) is crucial for a precise diagnosis and further immunotherapy. Companies providing in vitro diagnostic methods in allergology continuously strive for the optimization and modernization of such methods. A new generation of automated allergy tests based on chemiluminescence detection and paramagnetic microparticles is now available, with possible advantages in sample volume, cost-effectiveness and avoidance of sample-related interference. Objectives: To test whether sIgE antibody levels obtained with a new singleplex chemiluminescent method have a good agreement with the corresponding results obtained with a “gold standard” test. Methods: We tested sera from 368 AR patients. Specific IgE sera levels (kU/L) to a comprehensive panel of 15 allergen extracts and 6 molecules were tested with ImmunoCAP® (Thermo Fisher Scientific Inc, Phadia AB, Uppsala, Sweden) and NOVEOS™ (HYCOR® Biomedical, Garden Grove, CA, USA). We evaluated the qualitative and quantitative performance of the new NOVEOS system in matching the outcome of ImmunoCAP to each of the examined allergens. Results: In relation to ImmunoCAP, the overall diagnostic sensitivity and specificity of sIgE tests with NOVEOS were 90.8% (95% CI = 88.6–92.7) and 96.2% (95% CI = 93.9–97.8), respectively. These values were higher when only molecules were considered (sensitivity = 98.7% [95% CI = 96.4%–99.7%]; specificity = 94.2% [95% CI = 88.4%–97.6%]) and lower when only extracts were considered (sensitivity = 87.6% [95% CI = 84.7%–90.2%]; specificity = 97% [95% CI = 94.4%–98.6%]). Spearman's correlation between the data set of both methods for a ≥ 0.1 kU/L cut-off was 0.84 (p <.001). Conclusions: The new singleplex NOVEOS system presented good results for qualitative and quantitative comparisons when testing specific serum IgE antibodies against a range of 21 allergens. This novel immunoassay system using only 4 µl of sample per test appears to be robust and reliable and can, therefore, be used as an aid in allergy diagnosis.
AB - Background: The measurement of specific IgE to allergenic extracts and molecules in patients with allergic rhinitis (AR) is crucial for a precise diagnosis and further immunotherapy. Companies providing in vitro diagnostic methods in allergology continuously strive for the optimization and modernization of such methods. A new generation of automated allergy tests based on chemiluminescence detection and paramagnetic microparticles is now available, with possible advantages in sample volume, cost-effectiveness and avoidance of sample-related interference. Objectives: To test whether sIgE antibody levels obtained with a new singleplex chemiluminescent method have a good agreement with the corresponding results obtained with a “gold standard” test. Methods: We tested sera from 368 AR patients. Specific IgE sera levels (kU/L) to a comprehensive panel of 15 allergen extracts and 6 molecules were tested with ImmunoCAP® (Thermo Fisher Scientific Inc, Phadia AB, Uppsala, Sweden) and NOVEOS™ (HYCOR® Biomedical, Garden Grove, CA, USA). We evaluated the qualitative and quantitative performance of the new NOVEOS system in matching the outcome of ImmunoCAP to each of the examined allergens. Results: In relation to ImmunoCAP, the overall diagnostic sensitivity and specificity of sIgE tests with NOVEOS were 90.8% (95% CI = 88.6–92.7) and 96.2% (95% CI = 93.9–97.8), respectively. These values were higher when only molecules were considered (sensitivity = 98.7% [95% CI = 96.4%–99.7%]; specificity = 94.2% [95% CI = 88.4%–97.6%]) and lower when only extracts were considered (sensitivity = 87.6% [95% CI = 84.7%–90.2%]; specificity = 97% [95% CI = 94.4%–98.6%]). Spearman's correlation between the data set of both methods for a ≥ 0.1 kU/L cut-off was 0.84 (p <.001). Conclusions: The new singleplex NOVEOS system presented good results for qualitative and quantitative comparisons when testing specific serum IgE antibodies against a range of 21 allergens. This novel immunoassay system using only 4 µl of sample per test appears to be robust and reliable and can, therefore, be used as an aid in allergy diagnosis.
KW - allergic rhinitis
KW - IgE
KW - immunoassay
KW - interassay comparison
KW - precision medicine
KW - singleplex
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U2 - 10.1111/cea.13785
DO - 10.1111/cea.13785
M3 - Article
C2 - 33174280
AN - SCOPUS:85097751086
JO - Clinical and Experimental Allergy
JF - Clinical and Experimental Allergy
SN - 0954-7894
ER -