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
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.
研究概览
地位
研究类型
注册 (实际的)
联系人和位置
学习地点
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München、德国
- Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein, TUM Universitätsklinikum rechts der Isar,
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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To verify and confirm the optimal allergen concentration for stimulation and preliminary cut-offs in BÜHLMANN BAT
大体时间：From enrollment to the end of study at 4 months
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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).
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From enrollment to the end of study at 4 months
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次要结果测量
结果测量 |
大体时间 |
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Verification of agreement between tested BAT and the Certified BÜHLMANN Flow CAST® Basophil Activation Test
大体时间：From enrollment to the end of study at 4 months
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From enrollment to the end of study at 4 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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