Evaluation of an IgG Deficiency Rapid Screening Test (RDT) With Human Capillary Samples: A Protocol to Generate RDT Performance Data in Primary Immunodeficiency Patients (PID)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluateusability among end users of the PID rapid screening tests using capillary blood samples obtained from PID patients, prior to receipt of IV-Ig treatment.
研究概览
简要总结
To evaluate the usability and utility of the device, % agreement between the PID-RDT and the referent assay (serum/plasma), and % agreement between capillary blood and venous blood samples using the PID-RDT within confirmed PID patients prior to receipt of their monthly IV-Ig treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be 6 months of age.
- •The types of PID presenting for IV-Ig therapy will include Evaluation of PID RDT with human capillary blood (version 1.0) | 8agammaglobulinemia (AG), hypogammaglobulinemia (HAG), common variable immunodeficiency (CVID), and hyper IgM syndrome (HIGM).
排除标准
- 未提供
结局指标
主要结局
To evaluateusability among end users of the PID rapid screening tests using capillary blood samples obtained from PID patients, prior to receipt of IV-Ig treatment.
时间窗: 3 month
- Did the test run correctly when following the IFU? •Was the end user (nurse) able to interpret a test result for the patient from the investigational PID RDT (positive, negative) with valid control using a patient's capillary finger prick sample?
To evaluate % agreement between the PID RDT(using capillary blood)and the referent test (serum/plasma).
时间窗: 3 months
What is the % agreement between the PID RDT run on capillary blood (Capillary Test A) and the referent assay run on plasma/serum?
次要结局
- To determinethe utility of the PID RDTwith PID patients.(3 months)
- To determine% agreement between capillary and venous blood samples using the PID RDT(3 months)
研究者
Megan Parker
Senior Program Officer
PATH