Ann Lab Med 2018; 38(4): 338-347  
Allergen Microarrays for In Vitro Diagnostics of Allergies: Comparison with ImmunoCAP and AdvanSure
Hyunjin Jeon, M.S.1*, Joo Hyun Jung, M.D.2*, Yoonji Kim, B.S.1,3, Youngeun Kwon, Ph.D.1, and Seon Tae Kim, M.D.2
Department of Biomedical Engineering (BK21 Plus)1, Dongguk University, Seoul; Department of Otolaryngology2, Gil Medical Center, Gachon University, Incheon; Department of Research and Development3, Won Medical Co., Bucheon, Korea
Corresponding author: Youngeun Kwon
Department of Biomedical Engineering (BK21 Plus), Dongguk University, 401 Sangyoung Biocomplex, 27 Dongguk-ro, Ilsandong-gu, Goyang 10326, Korea
Tel: +82-31-961-5151
Fax: +82-31-961-5108
E-mail: ykwon@dongguk.edu
Co-corresponding author: Seon Tae Kim
Department of Otolaryngology, Gil Medical Center, Gachon University College of Medicine, 21 Namdong-daero 774beon-gil, Namdong-gu, Incheon 21565, Korea
Tel: +82-32-460-3764
Fax: +82-32-467-9044
E-mail: kst2383@gilhospital.com
*These authors contributed equally to this work.
Received: June 22, 2017; Revised: October 16, 2017; Accepted: March 12, 2018; Published online: July 1, 2018.
© Korean Society for Laboratory Medicine. All rights reserved.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background: In vitro detection of the allergen-specific IgE antibody (sIgE) is a useful tool for the diagnosis and treatment of allergies. Although multiple simultaneous allergen tests offer simple and low-cost screening methods, these platforms also have limitations with respect to multiplexibility and analytical performance. As an alternative assay platform, we developed and validated a microarray using allergen extracts that we termed “GOLD” chip.
Methods: Serum samples of 150 allergic rhinitis patients were used in the study, and the diagnostic performance of the microarray was compared with that of AdvanSure (LG Life Sciences, Daejun, Korea) and ImmunoCAP (Phadia, Uppsala, Sweden). Standard IgE samples were used for the quantitative measurement of sIgEs.
Results: The microarray-based assay showed excellent performance in the quantitative measurement of sIgEs, demonstrating a linear correlation within the range of sIgE concentrations tested. The limit of detection (LOD) was lower than 0.35 IU/mL, which is the current standard for the LOD cut-off. The assay also provided highly reproducible sets of data. The total agreement percentage of positive and negative calls was 92.2% compared with ImmunoCAP. Moreover, an outstanding correlation was observed between the microarray and the ImmunoCAP results, with Cohen’s kappa and Pearson correlation coefficient values of 0.80 and 0.79, respectively.
Conclusions: The microarray-based in vitro diagnostic platform offers a sensitive, reproducible, and highly quantitative method to detect sIgEs. The results showed strong correlations with that of ImmunoCAP. These results suggest that the new allergen microarray can serve as a useful alternative to current screening platforms, ultimately becoming a first-line screening method.
Keywords: Allergy, Allergic rhinitis, Allergen microarray, sIgE, In vitro diagnostics, Performance evaluation



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