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Allergen Microarrays for In Vitro Diagnostics of Allergies: Comparison with ImmunoCAP and AdvanSure

Authors
Jeon, HyunjinJung, Joo HyunKim, YoonjiKwon, YoungeunKim, Seon Tae
Issue Date
Jul-2018
Publisher
KOREAN SOC LABORATORY MEDICINE
Keywords
Allergy; Allergic rhinitis; Allergen microarray; sIgE; In vitro diagnostics; Performance evaluation
Citation
ANNALS OF LABORATORY MEDICINE, v.38, no.4, pp.338 - +
Journal Title
ANNALS OF LABORATORY MEDICINE
Volume
38
Number
4
Start Page
338
End Page
+
URI
https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/3577
DOI
10.3343/alm.2018.38.4.338
ISSN
2234-3806
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.
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