Exploratory Pilot Study of BÜHLMANN Automated Basophil Activation Test as an Aid to Diagnosis of Immediate Type Allergic Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- To verify and confirm the optimal allergen concentration for stimulation and preliminary cut-offs in BÜHLMANN BAT
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with diagnosis of a hypersensitivity / allergy to one of the 6 allergens, established according to common clinical practice
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
To verify and confirm the optimal allergen concentration for stimulation and preliminary cut-offs in BÜHLMANN BAT
时间窗: 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).
次要结局
- 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)