A Multicenter Clinical Evaluation Study to Determine the External Site Accuracy of Total Immunoglobulin E Measurement Using a Novel Point of Care Test Device Compared to a Reference Method in Atopic Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 12
- 主要终点
- Total IgE concentration
研究概览
简要总结
The purpose of this study is to determine the accuracy of the Novel point of care test (POCT) total IgE assay in atopic patients.
120 patients with atopic conditions and approximately 40 healthy subjects will be enrolled. Fingerstick capillary blood samples will be collected and tested in the POCT device. Venous samples will be collected and sent to a reference laboratory for measurement of serum total IgE using the reference immunoassay method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •atopic patients
- •Subjects who are diagnosed with atopic condition
- •Subjects or legal guardians who are able to give informed consent
- •Other protocol-defined inclusion criteria may apply
排除标准
- •atopic patients
- •Subjects who have received anti-IgE antibody treatment
- •Subjects who have elevated IgE levels for reasons other than allergic conditions
- •Other protocol-defined exclusion criteria may apply Inclusion criteria: healthy subjects
- •Subjects who are able to give informed consent for participation in the study according to local requirements / law.
- •Exclusion criteria: healthy subjects
- •Subjects who have received anti-IgE antibody treatment
- •Subjects with a suspected or confirmed clinical diagnosis of an atopic condition
- •Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
Capillary Blood Sampling
Capillary blood sampling, collected as two fingerprick samples with POCT device and two venous samples
干预措施: Blood sample (Procedure)
Capillary Blood Sampling
Capillary blood sampling, collected as two fingerprick samples with POCT device and two venous samples
干预措施: POCT device (Device)
结局指标
主要结局
Total IgE concentration
时间窗: Day 0 or Day 1 (Visit 2: Blood sampling)
Total IgE concentration in capillary blood measured with the POCT device at Day 0 or Day 1 from enrollment. Total IgE concentration in venous blood measured with the reference method at Day 0 or Day 1 from enrollment.
次要结局
- Device usability questionnaire response(Day 0 or Day 1 (Visit 2: Blood sampling))