Evaluation and Correlation of SARS-Cov2 Virus IgG/IgM Rapid Test Cassette Clungene Test With the Standard Method of COVID19 Testing in Inpatients With or Without COVID19
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- IgG/IgM antibodies
研究概览
简要总结
The purpose of this study is to evaluate point of care SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene test and correlate it with the standard method of testing in inpatients who have tested positive or negative for COVID19.
详细描述
This is a laboratory testing study using the SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene test to determine the presence of IgM and IgG antibodies in subjects who have tested negative or positive for COVID-19. The study is observational and subjects will be assigned to one of two arms depending on the results of their nCOVID-19 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
- 否
入选标准
- •Received confirmed COVID-19 positive or negative test from Sharp HealthCare's standard method of testing.
- •Age >/=18 years old.
- •Access to a phone in the hospital room or an electronic device that is capable of receiving phone calls and/or video calls and/or e-mail.
- •Able to read/write/speak English or Spanish fluently.
- •Subjects must have the ability to understand the requirements of the study, provide informed consent, and provide authorization of use and disclosure of personal health information.
- •Hospitalized at the time of consent or recently discharged with leftover blood stored at hospital laboratory
排除标准
- •Impaired cognitive or decision-making capacity (based on the clinical judgment of the PI or designee)
结局指标
主要结局
IgG/IgM antibodies
时间窗: from date of consent to date of test completion, up to 40 days
Presence of IgG and/or IgM antibodies
次要结局
未报告次要终点
研究者
Fadi Haddad, M.D.
Infectious Disease Specialist
Sharp HealthCare