Allergy Diagnostic Test Based on Microchip Technology

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Status: Not yet enrolling

Conditions: Allergy;Food; Allergy Drug; Allergy Pollen; Allergy

Treatments: Diagnostic Test: Routine allergy tests; Diagnostic Test: Newly developed microarray-based diagnostic test system

Study type: Interventional

Funder types: Other

Identifiers

NCT06167564

IBCE_Allergytest

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Routine allergy tests

Active Comparator group

Description:

Routine allergy tests (prick tests, specific IgE detection) will be done to establish the sensibilization of the patient.

Treatment:

Diagnostic Test: Routine allergy tests

Newly developed microarray-based diagnostic test system

Experimental group

Description:

Newly developed microarray-based diagnostic test system will be used to establish the sensibilization of the patient.

Treatment:

Diagnostic Test: Newly developed microarray-based diagnostic test system