Evaluation of Concordance Between an Innovative Test on Exhaled Air (eBAM-CoV) and RT-PCR to Detect SARS-CoV-2 in Symptomatic Patients or Closed Contacts
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Concordance between eBAM-Cov test and RT -PCR test to detect SARS-CoV -2 infection
研究概览
简要总结
During the COVID-19 pandemic, testing primarily relied on the use of nasopharyngeal swabs to detect the SARS-CoV-2 virus, responsible for the disease. However, this technique has several limitations, including the variable quality of swabs, its invasive nature, and arbitrariness in the choice of the number of cycles. Furthermore, it does not allow for the detection of viral proteins.
To overcome these limitations, researchers developed the eBAM-CoV test, patented for the detection of viral proteins in the exhaled air of COVID-19 patients. This portable device provides an immediate assessment of the "viral load" with both quantitative and qualitative results, showing promise for early virus detection.
The researchers hypothesize that the eBAM-CoV test is likely to exhibit a satisfactory concordance with the reference RT-PCR test in the detection of COVID-19, especially among symptomatic patients or closed contacts.
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
- 是
入选标准
- •Adult male or female patients over 18 years of age (≥)
- •Suspected of being infected with COVID-19 (symptomatic or contact case) and consulting for RT-PCR screening.
排除标准
- •Inability to understand the procedures to use the device
- •Patient participating in an another interventional study
- •Patient in exclusion period determined by another study
- •Patient under court protection or guardianship
- •Patient/trusted person/legal representative/family member for whom it is impossible to give informed information.
- •Pregnant, parturient or breast-feeding patient
研究组 & 干预措施
Patients likely to be affected by COVID-19
The study population consists of adult people who are likely to be affected by COVID-19 (symptomatic or close contacts) consulting for RT-PCR screening.
干预措施: eBAM Cov Testing (Device)
结局指标
主要结局
Concordance between eBAM-Cov test and RT -PCR test to detect SARS-CoV -2 infection
时间窗: Day 0
Evaluate the performance of the eBAM-CoV test by measuring the concordance between the eBAM-CoV method and the reference RT-PCR method (known as the "gold standard") in detecting SARS-CoV-2 in subjects likely to be infected with COVID-19 (symptomatic or closed contacts).
次要结局
- Concordance between eBAM-CoV test and antigenic test(Day 0)
- concentration of SARS-CoV-2 viral proteins(Day 0)
- diagnostic performance of the eBAM-CoV test(Day 0)
- Early detection of SARS-CoV-2 using eBAM-CoV test versus RT-PCR(Day 4)