Blood Specimen Collection for COVID-19 Immunity Assessment Mailer Kit Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 662
- 试验地点
- 1
- 主要终点
- Neutralizing Antibody Levels
研究概览
简要总结
The purpose of this study is to collect blood specimens from individuals post infection or post vaccination over time to assess COVID19 Immunity.
详细描述
The DxTerity COVID-19 Immunity Assessment Collection Mailer Kit contains the DxCollect MicroCollection Device (MCD) Serology fingerstick blood collection device packaged as a home collection kit, designed for collection and shipment of fingerstick blood back to DxTerity CLIA (Clinical Laboratory Improvements Amendment) certified laboratory for testing.
The clinical performance of the collection device for use with anti-SARS-CoV-2 antibody tests will be evaluated for use with cPASS™ anti-SARS-CoV-2 neutralizing antibody detection kit (EUA 201427).
The samples may also be used for assessing immunity or protection post COVID-19 vaccination.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females ≥13 years old.
- •Not vaccinated and were previously positive for COVID-19 OR are vaccinated for COVID-
- •Provides test report to demonstrate prior COVID-19 positive result (only applicable to unvaccinated subjects who were previously positive for COVID-19, not applicable for COVID-19 vaccinated subjects).
- •Provides informed consent and completed questionnaire.
- •Able to register the collection kit on the DxTerity portal.
- •Able to collect and ship blood samples back to DxTerity.
排除标准
- •Unable to provide COVID-19 positive test report (only applicable to unvaccinated subjects who were previously positive for COVID-19, not applicable for COVID-19 vaccinated subjects).
- •Unable to complete informed consent and/or questionnaire.
- •Unable to complete the study activities in a timely manner.
结局指标
主要结局
Neutralizing Antibody Levels
时间窗: 3 months
Measuring neutralizing antibody levels with COVID-19 immunity assessment test
次要结局
未报告次要终点