Use of the ANTIBODY BASED LATERAL FLOW IMMUNOASSAY TESTS FOR SARSCoV-2 THAT CAUSES CORONAVIRUS DISEASE 2019 (COVID-19) - Evaluation of Patients and Healthcare Providers in the Confines of Healthcare Settings
试验速览
- 阶段
- 不适用
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- prevalence of COVID-19 exposure
研究概览
简要总结
This study will be conducted as a registry to identify asymptomatic or symptomatic persons to determine whether they carry SARS-CoV-2 antibodies.
详细描述
This study will be conducted as a registry to identify asymptomatic or symptomatic persons to determine whether they carry SARS-CoV-2 antibodies. The blood test data will be collected as allowed by the EUA using the CoronaCideTM COVID-19 IgM/IgG Rapid Test and the Premier Biotech COVID-19 IgM/IgG Rapid Test. Both COVID-19 IgM/IgG Rapid Tests are intended for Over-The-Counter/Professional use as a screening aid in the diagnosis of primary and secondary SARSCoV-2 infections, and are only for use under the FDA's EUA.
The RNA test data will be collected via a nasopharyngeal swab and processed using the Abbott ID NOW COVID-19 diagnostic test.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient is Under the care of Texas Cardiac Arrhythmia, and Presenting to the hospital OR Presenting to a clinic conducted by Texas Cardiac Arrhythmia Or
- •An employee of Texas Cardiac Arrhythmia Or
- •An employee or healthcare professional working with patients receiving cardiac electrophysiology care at a hospital. Or A professional first responder to include Emergency Medical Services (EMS), Police or Fire departments.
排除标准
- •Any person who refuses to undergo study procedures
结局指标
主要结局
prevalence of COVID-19 exposure
时间窗: Mar-Dec 2020
To evaluate the prevalence of COVID-19 exposure to healthcare staff, community 1st responders and patients. and patient population within a subspecialty
次要结局
- correlate subsequent healthcare utilization with test results and baseline symptoms(Mar-Dec 2020)
- correlate pre-existing risk factors with test results and baseline symptoms(Mar-Dec 2020)
- correlation between the test results with the presence or lack of COVID-19 symptoms or illness(Mar-Dec 2020)