Feasibility Study of a New Immunoglobulin E (IgE) Assay Method in Urine and Blood
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,376
- 试验地点
- 2
- 主要终点
- Estimation of the the correlation of specific IgE concentrations for a given allergen analyzed using two different methods
研究概览
简要总结
The main objective is to study the feasibility of a new specific IgE assay using a bioluminescence technique in a pediatric and adult allergic population. For this, we will collect blood, and urine during a blood test scheduled for the follow-up of the patient.
详细描述
Allergy is a raising public health problem. Specific IgE assays are useful tools to investigate the physiopathology of allergies. This method is achieved mainly by the ImmunoCAP enzyme immunoassay technique. This is an expensive test that requires a significant amount of blood. This is a limitation particularly in children. The time to get the results is long and a second consultation has to be scheduled in order to communicate the results to the patients. The main objective of this study is to assess the feasibility of a new specific IgE assay, named LuLISA, using a bioluminescence technique in urine and blood samples from pediatric and adult allergic population. This technique was recently published for the quantification of IgE against two peanut allergens and needs to be extended for the detection of other major allergens. A secondary objective is the evaluation of the time needed to obtain results.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 6 months' old or older
- •Sensitization or allergy towards a trophallergen, an aeroallergen, hymenoptera venom or drug proven by:
- •positive skin test (s)
- •and / or IgE specific (s)> 0.1 kUA / L
- •and / or anamnesis in favor of an allergic reaction of mediated IgE
- •Social coverage up to date
排除标准
- •Children younger than 6 months'old
- •Children's weight less than 10 kg
- •Pregnant or breastfeeding women
- •Patients with cystic fibrosis
- •Patients with dysimmune or autoimmune pathology
- •Anamnesis in favor of a delayed allergy or a contact allergy.
研究组 & 干预措施
People with sensitization or allergy
blood and urine will be collected during a blood test scheduled for the follow-up of the patient
干预措施: collection of blood and urine (Biological)
结局指标
主要结局
Estimation of the the correlation of specific IgE concentrations for a given allergen analyzed using two different methods
时间窗: Day 0
specific IgE concentrations for a given allergen will be measured by both LuLISA and ImmunoCAP and the results will be compared
次要结局
- To study the correlation between the results of specific IgE dosages in the venous blood and the capillary blood(Day 0)
- To study the correlation between the results of specific serum and urinary IgE dosages by LuLISA(Day 0)