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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Allergy Testing Cat Epithelium Allergy Dust Mite Allergy Food Hypersensitivity Hazelnut Allergy House Dust Mite Allergy Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Nut and Peanut Hypersensitivity Otorhinolaryngologic Diseases Peanut Allergies Peanut Hypersensitivity Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial Venom Allergy Venom Hypersensitivity

Age range

18 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

München, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

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

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).

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

Sponsors and collaborators

Lead sponsor

Bühlmann Laboratories AG

Industry

Collaborators

Technical University Munchen

Registry information

Official study title

Exploratory Pilot Study of BÜHLMANN Automated Basophil Activation Test as an Aid to Diagnosis of Immediate Type Allergic Disorders

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: May 19, 2026
Registry last updated: Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting