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

NCT07596303 | Not Yet Recruiting

• 1 other identifier: BAT_ExploratoryPilotStudy2026
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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).

  From enrollment to the end of study at 4 months

Secondary Outcomes (1)

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

  From enrollment to the end of study at 4 months

Study Arms (1)

Allergy / hypersensitivity to the 6 allergens

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.

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bühlmann Laboratories AG: lead
• Technical University Munchen: collaborator

Study Sites (1)

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

München, Germany

Location

MeSH Terms

Conditions

Peanut Hypersensitivity; Venom Hypersensitivity; Dust Mite Allergy

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis, Allergic, Perennial; Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start: May 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

DE (1)