Capturing Infectious COVID-19 Asymptomatic Cases in Singapore
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Assess the performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 compared viral culture, over multiple collection time points
研究概览
简要总结
This study is being conducted to assess the performance of the BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2, used in serial testing, in identification of infectious, asymptomatic individuals. This information may be used to inform development of an effective testing strategy by policy makers.
详细描述
This multi-center, prospective, observational, diagnostic evaluation study is designed to assess the performance of the BD Veritor System in the detection of SARS-CoV-2 in asymptomatic individuals compared to viral culture and a commercially available RT-PCR assay over multiple testing time points. The study will enroll a minimum of 150 asymptomatic, adult participants who test positive for SARS-CoV-2 during community/traveler screening procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥21 years of age at the time of informed consent
- •Has a positive screening test for SARS-CoV-2 by RT-PCR
- •Is asymptomatic for COVID-19 on the day of their positive screening test (may have symptoms on the actual day of study enrollment)
- •Is expected to remain at the study site for the full 6-day study period
- •Willing and able to complete all study required procedures
- •Provision of signed and dated informed consent form
排除标准
- •History of frequent or difficult to control nosebleeds within the 14 days prior to study participation
- •If, at the discretion of the Investigator, involvement in the study is likely to jeopardize the subject's health or their current or future medical treatment
结局指标
主要结局
Assess the performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 compared viral culture, over multiple collection time points
时间窗: 6 days
* Assay results: Positive percent agreement (PPA) * Assay results: Negative percent agreement (NPA)
次要结局
- Assess the performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 compared to a commercially available RT-PCR asay, over multiple collection time points(6 days)
- Assess the performance a commercially available RT-PCR assay compared to viral culture, over multiple test time points(6 days)