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

Bühlmann Laboratories AG60 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Allergy Testing Peanut Allergies Venom Allergy House Dust Mite Allergy Hazelnut Allergy Cat Epithelium Allergy

Eligibility

Medical Language ↔ Plain English

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

Locations (1)

Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein, TUM Universitätsklinikum rechts der Isar,

München, Germany

RECRUITING

Outcomes

Primary Outcomes

To verify and confirm the optimal allergen concentration for stimulation and preliminary cut-offs in BÜHLMANN BAT

To verify and confirm the optimal allergen concentration for stimulation and preliminary cut-offs in BÜHLMANN BAT using fresh whole blood samples from clinically characterized allergic individuals (mainly using patient's history, skin prick test, detection of sIgE, basophil activation test or provocation test).

Time frame: From enrollment to the end of study at 4 months

Secondary Outcomes

Verification of agreement between tested BAT and the Certified BÜHLMANN Flow CAST® Basophil Activation Test

Time frame: From enrollment to the end of study at 4 months