BÜHLMANN BAT (Basophil Activation Test) in Allergy Diagnosis (Exploratory Pilot Study)

BÜHLMANN Laboratories

Status: Enrolling

Conditions: Cat Epithelium Allergy; House Dust Mite Allergy; Venom Allergy; Peanut Allergies; Allergy Testing; Hazelnut Allergy

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT07596303

BAT_ExploratoryPilotStudy2026

Details and patient eligibility

About

The goal of this exploratory pilot study is to generate early data needed for future validation studies of the automated BÜHLMANN BAT (Basophil activation test) assay. The main questions it aims to answer are:

Does the BAT assay use the optimal allergen concentrations for stimulation, and how do its preliminary cut-offs perform in a real-world clinical scenario?

Participants older than 1.5 years who are being evaluated for possible allergy sensitization will provide one additional blood tube during their routine blood draw as part of the regular medical care. The study involves only one visit and does not provide direct personal benefit.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals with diagnosis of a hypersensitivity / allergy to one of the 6 allergens, established according to common clinical practice

Exclusion criteria

• Pregnant women
• Children under the age of 18 months
• Individuals under therapy with Omalizumab or Rituximab
• Individuals with an allergic reaction less than two weeks before blood sample collection
• Individuals under therapy with BTK inhibitors
• Individuals receiving allergen specific immunotherapy (ASIT)
• Subjects with active infection and inflammatory conditions
• Patients who are unable to understand the study information and informed consent form in German

Trial design

60 participants in 1 patient group

Allergy / hypersensitivity to the 6 allergens

Description:

10 patients, each with an allergy / hypersensitivity to the following allergens: (i) Peanut, (ii) Hazelnut, (iii) Honey Bee, (iv) Yellow Jacket Venom, (v) House Dust Mite (HDM) (vi) Cat Epithelium. No additional non-allergic control subjects will be recruited specifically for this study. Participants with a clinically confirmed hypersensitivity to one of the six investigated allergens will serve as allergen-specific controls for the remaining allergens for which they have no known hypersensitivity.