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Development of an automated ImmunoCAP research assay for eosinophil derived neurotoxin and its use in asthma diagnosis in children.

ABSTRACT: Background:Eosinophil Derived Neurotoxin (EDN) is an eosinophil granule protein that is released during eosinophil activation. EDN has proven to be a promising marker for eosinophilic inflammation both in asthma and in wheezing symptoms in children. Objectives:Here we present a novel ImmunoCAPTM automated immunofluorescence research assay for measurement of EDN and its potential use in diagnosis of asthmatic children. Methods:We report the analytical performance of the assay in serum, heparin- and EDTA-plasma in terms of precision, linearity, sensitivity, interfering substances and specimen handling. We also compared the EDN research assay with established methods for asthma diagnosis: fraction of exhaled nitric oxide (FeNO) and blood eosinophil fraction (EOS%) to demonstrate the diagnostic value of EDN in childhood asthma. Results:The total precision (measured using percentage CV) was ?5.8% for both serum and plasma. The dilution analysis yielded linear results across the dynamic range of the assay for both serum and plasma. No notable interferences of endogenous substances were observed.The median concentration of EDN was significantly higher in the asthma group compared to the healthy controls and the EDN correlates well with EOS%. Conclusions:we have shown that EDN can be measured reliably and robustly with the ImmunoCAP platform in both serum and plasma samples. EDN can be used to distinguish asthmatic from healthy children and correlates well with EOS% and could be a valuable complement to both EOS% and FeNO.

SUBMITTER: Rydell N

PROVIDER: S-EPMC6804739 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Development of an automated ImmunoCAP research assay for eosinophil derived neurotoxin and its use in asthma diagnosis in children.

Rydell Niclas N Nagao Mizuho M Ekoff Helena H Sjölander Anders A Borres Magnus M Fujisawa Takao T

Practical laboratory medicine 20190919

<h4>Background</h4>Eosinophil Derived Neurotoxin (EDN) is an eosinophil granule protein that is released during eosinophil activation. EDN has proven to be a promising marker for eosinophilic inflammation both in asthma and in wheezing symptoms in children.<h4>Objectives</h4>Here we present a novel ImmunoCAP<sup>TM</sup> automated immunofluorescence research assay for measurement of EDN and its potential use in diagnosis of asthmatic children.<h4>Methods</h4>We report the analytical performance ...[more]

PMID: 31649990

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Project description:BackgroundThe use of inhaled corticosteroid (ICS) medications has been shown to improve asthma control and reduce asthma-related morbidity and mortality. Two recent randomized trials demonstrated dramatic improvements in ICS adherence by monitoring adherence with electronic sensors and providing automated reminders to participants to take their ICS medications. Given their lower levels of adherence and higher levels of asthma-related emergency department (ED) visits, hospitalizations, and death, urban minority populations could potentially benefit greatly from these types of interventions.ObjectiveThe principal objective of this study will be to evaluate the feasibility, acceptability, and limited efficacy of a text message (short message service, SMS) reminder intervention to enhance ICS adherence in an urban minority population of children with asthma. We will also assess trajectories of ICS adherence in the 2 months following asthma hospitalization.MethodsParticipants will include 40 children aged 2-13 years, who are currently admitted to the Children's Hospital of Philadelphia (CHOP) for asthma, and their parent or legal guardian. Participants will be assigned to intervention and control arms using a 1:1 randomization scheme. The intervention arm will receive daily text message reminders for a 30-day intervention phase following hospitalization. This will be followed by a 30-day follow-up phase, in which all participants may choose whether or not to receive the text messages. Feasibility will be assessed by measuring (1) retention of the participants through the study phases and (2) perceived usefulness, acceptability, and preferences regarding the intervention components. Limited efficacy outcomes will include percent adherence to prescribed ICS regimen measured using Propeller Health sensors and change in parent-reported asthma control. We will perform an exploratory analysis to assess for discrete trajectories of adherence using group-based trajectory modeling (GBTM).ResultsStudy enrollment began in December 2015 and the intervention and follow-up phases are ongoing. Results of the data analysis are expected to be available by December 2016.ConclusionsThis study will add to the literature by providing foundational feasibility data on which elements of a mobile health text-message reminder intervention may need to be modified to suit the needs and constraints of high-risk urban minority populations.Trial registrationClinicaltrials.gov NCT02615743; https://www.clinicaltrials.gov/ct2/show/study/NCT02615743 (Archived with WebCite at http://www.webcitation.org/6ji59rAXN).

Dataset Information

Development of an automated ImmunoCAP research assay for eosinophil derived neurotoxin and its use in asthma diagnosis in children.

Publications

Development of an automated ImmunoCAP research assay for eosinophil derived neurotoxin and its use in asthma diagnosis in children.

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