Pilot Testing Manual For Validation Purposes Providing Clearance for COVID-19 Tested Individuals Using the TERA Bio Station T101
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Clearing at least 80% of the healthy population
研究概览
简要总结
TERABio Ltd. has developed a rapid screening tool intended to determine if a tested individual is COVID-19-free (Negative to COVID-19).
详细描述
The goal of the pilot is to perform a localized validation to the TERA Bio Tests by TERA Bio Station(s). Success Criteria: Clearing at least 80% of the healthy population.
Pilot duration: approx. 6-10 work weeks long.
Research Population Requirements:
Male and Female, age ≥ 18 years old, whose COVID-19 virus infection status is known and verified for at least the last 24 hours (prior to the TERA.Bio test).
The study will include a minimum of 300 tested Positive individuals and a minimum of 700 Negative individuals, tested during the 24 hours prior to the TERA.Bio test.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years old (under 18 years old - only if it is allowed under local regulations and with legal guardian's approval and consent if needed.
- •COVID-19 virus infection status is known and verified 24 hours prior to a TERA.Bio test by RT-PCR and if required, a repeated PCR test based on symptomatic status and or / the CT value of the tested individual.
- •Signed Informed consent form.
排除标准
- •Discrepancies to inclusion criteria
- •Individuals under general anaesthesia
- •Individuals lacking the capability to personally sign the consent form.
- •Individuals lacking the capability to exhale breath.
结局指标
主要结局
Clearing at least 80% of the healthy population
时间窗: 7 Weeks (Estimated)
TERABio Ltd. has developed a rapid screening tool intended to determine if a tested individual is COVID-19-free (Negative to COVID-19). The goal of the pilot is to perform a localized validation to the TERA Bio Tests by TERA Bio Station(s)- Success Criteria -Clearing at least 80% of the healthy population.
次要结局
未报告次要终点