Evaluation of the COVIDSeq Test in Nasal Swab and Saliva From an Asymptomatic Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 644
- 试验地点
- 1
- 主要终点
- Positive percent agreement (PPA) and negative percent agreement (NPA) between the COVIDSeq Test and a comparator EUA test for the detection of SARS-CoV-2 RNA
研究概览
简要总结
"This is a prospective, single-center specimen collection study. Subjects 18 years of age or older who do not have symptoms of COVID-19 will be enrolled. Two nasal swab samples and one saliva sample will be collected from each subject. The saliva sample will be tested with the COVIDSeq Test and one nasal swab will be tested with an EUA approved COVID test. The other nasal swab sample will be stored and a subset (approximately 250 specimens) will be tested with the COVIDSeq Test. Results of all testing will be provided to the sponsor for statistical analysis.
Results from the comparator EUA test will be provided to the collection site investigator or designated collection site study staff. No medical treatment, guidance on treatment decisions, nor medical care will be provided. "
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •An individual must meet the criteria below to be eligible.
- •Individual is attending or invited to visit a participating collection site.
- •Individual is 18 years or older at the time of consent.
- •Individual is feeling well at the time of consent or specimen collection and does not have any of the following symptoms of COVID-19 per the current CDC guidance such as cough, shortness of breath or difficulty breathing, fatigue, fever or chills, muscle or body aches, headache, sore throat, new loss of taste or smell, congestion or runny nose, nausea or vomiting, or diarrhea.
- •Individual is willing to participate in study procedures and able to provide written informed consent in the English language.
排除标准
- •An individual cannot meet the below criteria.
- •Individual is confirmed to have COVID-19 and continues to require isolation in accordance with current CDC guidelines at the time of consent or specimen collection.
- •Individual is asymptomatic but suspected to have COVID-19 due to recent close contact (as currently defined by the CDC) with a person with COVID-19 and continues to require quarantine in accordance with current CDC guidelines at the time of consent or specimen collection. [5]
- •Individual had symptoms of COVID-19 less than 10 days before time of consent or specimen collection."
结局指标
主要结局
Positive percent agreement (PPA) and negative percent agreement (NPA) between the COVIDSeq Test and a comparator EUA test for the detection of SARS-CoV-2 RNA
时间窗: 1 month
次要结局
未报告次要终点