Evaluation Of the Basophil Activation Test in Child Egg Allergy Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Specificity of the BAT
研究概览
简要总结
In this study, basophil activation test (BAT) established by the investigators' lab was evaluated for its sensitivity and specificity in child egg allergy diagnosis. Children with suspected IgE mediated allergy to egg will be recruited in the study. Specific IgE to egg allergen and BAT will be detected. The diagnostic accuracy of the BAT will be assessed against clinical diagnosis based on history, clinical symptoms and laboratory results.
详细描述
In china, the prevalence of food allergy in in preschool children was about 7%. Diagnosis of food allergy is mainly based on a combination of clinical history, clinical manifestations and related supplementary examinations, including skin prick testing (SPT), serum specific IgE testing (sIgE), and oral food challenge (OFC). Although OFC is the gold standard for allergy diagnosis, it is rarely conducted in clinic for the low safety. Until now, serum specific IgE assays against allergen are the most commonly used in vitro diagnostic approach in China. However, specific-IgEs are sensitive, but not specific for diagnosis of food allergy. Moreover, food allergy could not be excluded when sIgE results are negative (<0.35KU/L). Thus, more accurate and safer test is needed. BAT was shown to have good accuracy for food allergy diagnosis. BAT is an ex vivo functional assay that measures by flow cytometry the degree of basophil activation after stimulation with an allergen. However, experimental strategies for BAT reported in the literatures are different. Some research even used 12 kinds of antibodies to identity basophils. In previous study, the investigators established BAT using 4 kinds of antibodies. Basophils could be distinguished well from other cells. In this study, children aged 4 months to 6 years who visit pediatric and emergency department, and are suspected with egg allergy will be included in study. Detailed information about clinical history and manifestations will be collected. Serum sIgE to food and BAT will be detected. The proposed study intends to analyze sensitivity and specificity of the established BAT according to the clinical comprehensive diagnosis results, and evaluate its efficacy to diagnose food allergy in children.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Months 至 6 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •1.Patients with hematological tumors, autoimmune diseases, organ transplantation, and immunodeficiency diseases
- •2.Take immunosuppressants, immunomodulators, statins, and inject anesthetics within 3 weeks
结局指标
主要结局
Specificity of the BAT
时间窗: 2 days
Specificity is defined as the capacity for BAT to have a negative result when comprehensive diagnosis result is also negative.
Sensitivity of the BAT
时间窗: 2 days
Sensitivity of the BAT compare to clinical comprehensive diagnosis with a threshold value of 5% for the BAT in a population of child egg allergy. Sensitivity is defined as the capacity for BAT to have a positive result when comprehensive diagnosis result is also positive
次要结局
未报告次要终点
研究者
Xia Peng
associate senior technologist
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
