Determination of Accuracy in Measurement of Total Immunoglobulin E Using a Test Device in Atopic Subjects
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
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.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Hamburg、德国、20354
- Novartis Investigative Site
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Lübeck、德国、23552
- Novartis Investigative Site
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PD
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Padova、PD、意大利、35128
- Novartis Investigative Site
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PI
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Pisa、PI、意大利、56124
- Novartis Investigative Site
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RM
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Roma、RM、意大利、00168
- Novartis Investigative Site
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Manchester、英国、M23 9QZ
- Novartis Investigative Site
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Surrey
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Chertsey、Surrey、英国、KT16 0PZ
- Novartis Investigative Site
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West Yorkshire
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Bradford、West Yorkshire、英国、BD9 6RJ
- Novartis Investigative Site
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Almelo、荷兰、7609 PP
- Novartis Investigative Site
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Harderwijk、荷兰、3840 AC
- Novartis Investigative Site
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Barcelona
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Sabadell、Barcelona、西班牙、08208
- Novartis Investigative Site
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Comunidad Valenciana
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Valencia、Comunidad Valenciana、西班牙、46017
- Novartis Investigative Site
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria: 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 Exclusion criteria: 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Capillary Blood Sampling
Capillary blood sampling, collected as two fingerprick samples with POCT device and two venous samples
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Fingerprick and venous
Investigational device
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Total IgE concentration
大体时间：Day 0 or Day 1 (Visit 2: Blood sampling)
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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. |
Day 0 or Day 1 (Visit 2: Blood sampling)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Device usability questionnaire response
大体时间：Day 0 or Day 1 (Visit 2: Blood sampling)
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Device usability assessment of the POCT device as per operators at the completion of the study.
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Day 0 or Day 1 (Visit 2: Blood sampling)
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- CDIGE0012201
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