Allergy Diagnostic Test Based on Microchip Technology

Not Applicable

Not yet recruiting

• Conditions: Allergy; Allergy Drug; Allergy;Food; Allergy Pollen
• Interventions: Diagnostic Test: Newly developed microarray-based diagnostic test system; Diagnostic Test: Routine allergy tests

• Registration Number: NCT06167564
• Lead Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-10-20
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-04
• Last Update Submitted: 2023-12-04
• Study First Posted: 2023-12-12
• Last Update Posted: 2023-12-12
• Study Start: 2024-01-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Newly developed microarray-based diagnostic test system	Newly developed microarray-based diagnostic test system	Newly developed microarray-based diagnostic test system will be used to establish the sensibilization of the patient.
Routine allergy tests	Routine allergy tests	Routine allergy tests (prick tests, specific IgE detection) will be done to establish the sensibilization of the patient.

Primary Outcome Measures

Name	Time	Method
Serum IgE levels of the specific pollen allergens	1 month	Serum IgE levels of the specific pollen allergens will be sudied

Trial Locations

Locations (1)

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus; 🇧🇾 Minsk, Belarus