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

May 28, 2026 updated by: Bühlmann Laboratories AG

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

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • München, Germany
        • Recruiting
        • Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein, TUM Universitätsklinikum rechts der Isar,
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From enrollment to the end of study at 4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
From enrollment to the end of study at 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bühlmann Laboratories AG

Collaborators

Technical University Munchen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

May 18, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAT_ExploratoryPilotStudy2026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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