Immunoblot, Chemiluminescence and ImmunoCap Allergen Specific IgE Evaluation of in Allergic Rhinitis Patients

Study Overview
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Brief Summary
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In the present study the investigators assay house dust mites (HDMs) IgE in sera of allergic rhinitis patients (AR) using immunoblotting, chemiluminescence, and ImmunoCAP assays to compare between the accuracy of both immunoblotting and chemiluminescence assays, and ImmunoCAP as gold standard.

Detailed Description
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All allergic rhinitits patients who were monosensitized to mixed HDMs, identified by SPT, will be subjected to complete history taking and assessment of the inclusion and exclusion criteria, performance of skin prick test and measurement of total serum IgE, measurement of specific IgE by Chemiluminescence Immunoassa, immunoblot assay and ImmunoCAP™ Phadiatop™. The patients will be followed-up for 6 months.

Official Title
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Immunoblot and Chemiluminescence Assays Versus ImmunoCap: Evaluation of Allergen Specific IgE in Egyptian House Dust Mites Allergic Rhinitis Patients

Conditions
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Diagnoses Disease

Intervention / Treatment
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* Diagnostic Test: Sensitization to House dust mites


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient consent. Patient with (18-40) years age known to be allergic rhinitis. Patient with IgE mediated allergic rhinitis (positive total IgE). Patient with positive skin prick testing and monosensitized to HDM Exclusion Criteria: Patient refusal Patients taking oral corticosteroid. Patients taking anti-IgE injections. Patients taking intranasal corticosteroid. Patient with non- IgE mediated allergic rhinitis. Patients with chronic diseases.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allergic Rhinitis Patients<br>House dust mites (HDMs) IgE in sera of allergic rhinitis patients (AR) who were monosensitized to mixed HDMs, identified by SPT, is assayed using immunoblotting, chemiluminescence, and ImmunoCAP assays to compare between the accuracy of both immunoblotting and chemiluminescence assays, and ImmunoCAP as gold standard | Diagnostic Test: Sensitization to House dust mites<br>* The SPT is performed at the time of diagnosis and after six-months follow-up period. Serum specific IgE is measured by immunoblotting, chemiluminescence, and ImmunoCAP assays<br>* Other names: Measurement of serum specific IgE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of serum specific IgE | Improvement of symptoms and signs of allergy | 6 months from diagnosis to end of Follow-up period | 
| Conversion of SPT to negative | Improvement of symptoms and signs of allergy | 6 months from diagnosis to end of Follow-up period |