Development of a Diagnostic Test System Based on Microchip Technology for the Detection of IgE-dependent Allergic Reactions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Serum IgE levels of the specific pollen allergens
研究概览
简要总结
The purpose of this study is to develop a microarray-based diagnostic test system for the determination of allergen specific IgE in human blood serum.
详细描述
The purpose of this study is to develop a microarray-based diagnostic test system for the determination of allergen specific IgE in human blood serum samples and to assess the sensitivity and specificity of the developed system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type I allergy (food, drug, pollen)
- •The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
- •Written informed consent
排除标准
- •Acute or chronic diseases in the stage of decompensation (except allergy)
- •Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
- •Patients who are pregnant, breastfeeding
- •Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol
- •Patients are unable or unwilling to give written informed consent and / or follow research procedures
- •Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study
研究组 & 干预措施
Routine allergy tests
Routine allergy tests (prick tests, specific IgE detection) will be done to establish the sensibilization of the patient.
干预措施: Routine allergy tests (Diagnostic Test)
Newly developed microarray-based diagnostic test system
Newly developed microarray-based diagnostic test system will be used to establish the sensibilization of the patient.
干预措施: Newly developed microarray-based diagnostic test system (Diagnostic Test)
结局指标
主要结局
Serum IgE levels of the specific pollen allergens
时间窗: 1 month
Serum IgE levels of the specific pollen allergens will be sudied
次要结局
未报告次要终点