Assessing Performance of the Testing Done Simple Covid 19 Antigen Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 2
- 主要终点
- Sensitivity
研究概览
简要总结
This study will measure the sensitivity and specificity of the Testing Done Simple severe acute respiratory syndrome (SARS) CoV-2 antigen test in subjects with suspected Covid-19 that present throughout several urgent care clinics. The antigen test performance will be compared to a real-time polymerase chain reaction (RT-PCR) test.
详细描述
The Testing Done Simple antigen test is a lateral flow immunoassay that detects the presence of the SARS CoV-2 nucleoprotein and is primarily intended for use in an at home setting. The antigen test will be compared to a traditional RT-PCR tested nasal swab specimens. The purpose of study is to measure the performance of the Testing Done Simple test via sensitivity and specificity when compared to the gold-standard RT-PCR test. The test will be administered in symptomatic and asymptomatic subjects and participants will report the days that has passed since their symptom onset. The RT-PCR test will be performed prior to the Testing Done Simple 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
- •Subject was given a SARS CoV 2 PCR test for any of the following 4 reasons:
- •Subject has Covid like symptoms that started within past (7) days
- •Subject has been exposed to another individual with a known Covid diagnosis or probable Covid diagnosis
- •Subject needs Covid test done for travel, school, work, etc
- •Subject works in a high risk environment
- •Subject can provide a nasal swab sample
- •Subject is at least 18 years of age
- •Subject was given a SARS CoV 2 PCR test on same day participating this study
- •Subject provides informed consent
排除标准
- •Subject is less than 18 years of age
- •Subject does not provide consent
- •Subject's Covid 19 related symptom(s) started greater than 7 days from visit
- •Asymptomatic subjects whom have had symptom(s) within past (14) days
- •Signs of local infection in the area of the face
- •Subject was not given a SARS CoV 2 PCR test on same day as study
结局指标
主要结局
Sensitivity
时间窗: 15 minutes
Sensitivity (True Positive Rate) of Testing Done Simple Antigen Test compared to RT-PCR
Specificity
时间窗: 15 minutes
Specificity (True Negative Rate) of Testing Done Simple Antigen Test compared to RT-PCR
次要结局
- Sensitivity in Relation to the Time Since Symptom Onset in Symptomatic subjects(15 minutes)