Assessment of Serological Techniques for Screening Patients Regarding COVID-19-COVID-SER
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- The positivity (Yes/No) of the serological test.
研究概览
简要总结
Covid-SER is a prospective multi-center study for the evaluation of diagnostic performance of available serological tests
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Seropositive caregivers screened for anti-SARS CoV2 antibodies during their consultation at the occupational medicine of HCL.
- •Age: ≥ 18 years old
- •Persons having given their written consent and accepting a follow-up every 6 months for 24 months, followed by a final visit at 36 months.
- •Persons affiliated to a social security scheme or beneficiary of such a scheme.
排除标准
- •Pregnant or lactating woman
研究组 & 干预措施
Serological tests will be applied on patients blood sampling
Serological tests will be applied on patients blood sampling
干预措施: Serological tests will be applied on patients blood sampling (Diagnostic Test)
结局指标
主要结局
The positivity (Yes/No) of the serological test.
时间窗: Day 42
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
The positivity (Yes/No) of the serological test.
时间窗: Day 0
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
The positivity (Yes/No) of the serological test.
时间窗: Day 3
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
The positivity (Yes/No) of the serological test.
时间窗: Day 7
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
The positivity (Yes/No) of the serological test.
时间窗: Day 14
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
The positivity (Yes/No) of the serological test.
时间窗: Day 21
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
The positivity (Yes/No) of the serological test.
时间窗: Day 28
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
The positivity (Yes/No) of the serological test.
时间窗: Day 35
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
次要结局
未报告次要终点