Allergy Diagnostic Test Based on Microchip Technology

Study Overview
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Brief Summary
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The purpose of this study is to develop a microarray-based diagnostic test system for the determination of allergen specific IgE in human blood serum.

Detailed Description
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The purpose of this study is to develop a microarray-based diagnostic test system for the determination of allergen specific IgE in human blood serum samples and to assess the sensitivity and specificity of the developed system.

Official Title
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Development of a Diagnostic Test System Based on Microchip Technology for the Detection of IgE-dependent Allergic Reactions

Conditions
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Allergy, Allergy;Food, Allergy Pollen, Allergy Drug

Intervention / Treatment
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* Diagnostic Test: Routine allergy tests
* Diagnostic Test: Newly developed microarray-based diagnostic test system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type I allergy (food, drug, pollen) The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation Written informed consent Exclusion Criteria: Acute or chronic diseases in the stage of decompensation (except allergy) Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis Patients who are pregnant, breastfeeding Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol Patients are unable or unwilling to give written informed consent and / or follow research procedures Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Group of adult participants with IgE-dependent allergic reactions. Routine blood serum IgE levels will be compared with the newly developed microarray-based diagnostic test system.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Routine allergy tests<br>Routine allergy tests (prick tests, specific IgE detection) will be done to establish the sensibilization of the patient. | Diagnostic Test: Routine allergy tests<br>* Prick test, specific IgE detection<br>|
| Experimental: Newly developed microarray-based diagnostic test system<br>Newly developed microarray-based diagnostic test system will be used to establish the sensibilization of the patient. | Diagnostic Test: Newly developed microarray-based diagnostic test system<br>* Newly developed microarray-based diagnostic test system for the detection of the specific IgE<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum IgE levels of the specific pollen allergens | Serum IgE levels of the specific pollen allergens will be sudied | 1 month |