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Allergy Diagnostic Test Based on Microchip Technology

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06167564
Enrollment
400
Registered
2023-12-12
Start date
2024-01-01
Completion date
2024-12-31
Last updated
2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy, Allergy Drug, Allergy;Food, Allergy Pollen

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.

Interventions

DIAGNOSTIC_TESTRoutine allergy tests

Prick test, specific IgE detection

DIAGNOSTIC_TESTNewly developed microarray-based diagnostic test system

Newly developed microarray-based diagnostic test system for the detection of the specific IgE

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Serum IgE levels of the specific pollen allergens1 monthSerum IgE levels of the specific pollen allergens will be sudied

Countries

Belarus

Contacts

Primary ContactAndrei Hancharou, Dr
andrei.hancharou@gmail.com+375296248972

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026