Clinical Evaluation of the GRIP Influenza and SARS-CoV-2 Point-of-care Assays Using Fresh Patient Nasal Swab Samples
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Negative Percent Agreement
研究概览
简要总结
The purpose of this research is to determine if the use of a new device can accurately detect a virus infection.
详细描述
GRIP has developed a novel, graphene-based detection system for potential use in point-of-care settings. This study will compare the performance of the GRIP device to routine PCR testing for detection of COVID-19 and influenza viruses. When patients present for routine testing for COVID-19 and influenza, they will also have a separate nasal swab collected that will be tested by the GRIP point-of-care device.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients being tested for COVID 19 or Influenza
排除标准
- •Patients < 18 years of age
研究组 & 干预措施
Novel, graphene-based, point-of-care device
Subjects will receive one additional nasal swab at the same time as clinical collection.
干预措施: GRIP Electronic Diagnostic Chip (Device)
Novel, graphene-based, point-of-care device
Subjects will receive one additional nasal swab at the same time as clinical collection.
干预措施: Laboratory-based nucleic acid amplification tests (NAATs) (Diagnostic Test)
结局指标
主要结局
Negative Percent Agreement
时间窗: One hour
Percent of nasal swabs to report negative results for respiratory virus for both the GRIP device and NAAT routine clinical testing
Positive Percent Agreement
时间窗: One hour
Percent of nasal swabs to report positive results for respiratory virus for both the GRIP device and NAAT routine clinical testing
次要结局
未报告次要终点
研究者
Matthew J. Binnicker
Principal Investigator
Mayo Clinic