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.
Individuals with diagnosis of a hypersensitivity / allergy to one of the 6 allergens, established according to common clinical practice
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
Participants will be invited during a routine diagnostic visit to the Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein to contribute to the study by giving one additional sample tube. This extra sample will be collected alongside the venous blood samples already being taken as part of their standard care.
Case-control
Cross-sectional
Not listed
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).
Verification of agreement between tested BAT and the Certified BÜHLMANN Flow CAST® Basophil Activation Test
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Bühlmann Laboratories AG
Lead sponsor
Technical University Munchen
Collaborator
