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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07596303

Enrollment

Registered

2026-05-19

Start date

2026-05-15

Completion date

2026-06-25

Last updated

2026-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Months to No maximum

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

Design outcomes

Primary

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

Measure	Time frame
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

Countries

Germany

Outcome results