Ad Sensor-based Real-time Diagnosis of Adenovirus
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The performance of Ad sensor
研究概览
简要总结
To develop a real-time diagnostic technique with Ad sensor for Adenovirus detection, the investigators conduct a prospective clinical study. In comparison with results from direct sequencing of Adenovirus, the investigators evaluate the performance of Ad sensor , including reproducibility, sensitivity, specificity, and cross-reaction. The potential factors which may interfere with the results would be investigated. With such technique, the investigators hope to make early diagnosis and give Adenovirus patients early treatment to reduce the complications and case-fatality rate.
详细描述
- Sample acquirement： At National Taiwan University Hospital in Taiwan, we will enroll patients who have Adenovirus infection . We will take three throat swabs for each patient: one for viral isolation, one for RT-PCR and the last for the Ad sensor - based real-time diagnosis.
- Ad sensor diagnosis： Ad sensor (structural chip-based optosensing virus probing system), which is for the rapid and sensitive detection of viral antigen in medical samples, will be used for analyzing the interaction kinetics between anti-Adenovirus and its Adenovirus antigen present in patients'and normal samples.
- Gold standard： viral isolation and RT-PCR
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A: The patients with confirmed or suspected infection. B: The healthy person without disease.
排除标准
- 未提供
研究组 & 干预措施
Ad sensor
virus detection
干预措施: Ad sensor (Device)
结局指标
主要结局
The performance of Ad sensor
时间窗: 1 Day
In comparison with results from viral isolation and RT-PCR of Adenovirus , we evaluate the performance of Ad sensor, including sensitivity, specificity, cross-reaction and reproducibility.
次要结局
未报告次要终点