چکیده (انگلیسی):

Background: Immediate-type wheat allergy caused by a specific hydrolyzed wheat protein (HWP-IWA), Glupearl
19S (GP19S), typically develops food-dependent exercise-induced anaphylaxis (FDEIA), but is different
from conventional FDEIA, or simple wheat allergy in many aspects. The skin prick test (SPT) is considered to
be the most effective method for diagnosis of HWP-IWA. As SPT is a relatively qualitative method, we developed
quantitative and high-throughput test method for HWP-IWA.
Methods: An enzyme-linked immunosorbent assay (ELISA)-based GP19S-specific IgE assay was tested using
sera from 14 HWP-IWA and five conventional wheat-dependent exercise-induced anaphylaxis (COWDEIA)
patients, as well as five healthy subjects. Then a validation study at five different institutions was carried
out using sera from 10 HWP-IWA and five CO-WDEIA patients, as well as five healthy subjects different
from the previous studies.
Results: The mean unit values converted from measured absorbance of ELISA were 68.3, 1.3 and 1.1 respectively.
Furthermore, the validation study revealed reproducible results across all five institutions, with the
standard deviation (SD) being 0.3-0.4 for the healthy group, 0.2-0.6 for the CO-WDEIA group, and 3.8-9.6 for
HWP-IWA group except for one case. One case of HWP-IWA was excluded from analysis due to the high SD of
53.3 units, indicating that samples with a unit value > 100.0 will affect inter-laboratory reproducibility.
Conclusions: Our findings suggest that the ELISA-based GP19S-specific IgE assay can be used to test
HWP-IWA using venous blood samples, except for those with a unit value > 100.0.