TY - JOUR
T1 - Allergen microarrays for in vitro diagnostics of allergies
T2 - Comparison with ImmunoCAP and AdvanSure
AU - Jeon, Hyunjin
AU - Jung, Joo Hyun
AU - Kim, Yoonji
AU - Kwon, Youngeun
AU - Kim, Seon Tae
N1 - Publisher Copyright:
© Korean Society for Laboratory Medicine.
PY - 2018
Y1 - 2018
N2 - 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.
AB - 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.
KW - Allergen microarray
KW - Allergic rhinitis
KW - Allergy
KW - In vitro diagnostics
KW - Performance evaluation
KW - SIgE
UR - http://www.scopus.com/inward/record.url?scp=85045214938&partnerID=8YFLogxK
U2 - 10.3343/alm.2018.38.4.338
DO - 10.3343/alm.2018.38.4.338
M3 - Article
C2 - 29611384
AN - SCOPUS:85045214938
SN - 2234-3806
VL - 38
SP - 338
EP - 347
JO - Annals of Laboratory Medicine
JF - Annals of Laboratory Medicine
IS - 4
ER -