COVID-19 in Baselland: Investigation and Validation of Serological Diagnostic Assays and Epidemiological Study of Sars-CoV-2 Specific Antibody Responses (SERO-BL-COVID-19)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 477
- 试验地点
- 1
- 主要终点
- Qualitative method validation (yes/ no)
研究概览
简要总结
The study is to investigate the antibody response in the blood and saliva of people with a known COVID-19 infection in the canton of Baselland.
详细描述
This study is to analyse the antibody response in the blood and saliva of people with a known COVID-19 infection in the canton of Baselland.
The study aims to validate strategies to measure antibody levels with minimal intervention and to explore the antibody response and technical capacity for said measurement. The study will collect the minimally necessary samples to deduce a strategy for serum or saliva surveillance of the population of the canton Baselland. To achieve this, the study is designed to address the following points:
- determine specificity, sensitivity and general utility of point of care (POC) and ELISA tests to deduce a strategy for serum surveillance of the population of the canton Baselland
- especially validate different POC kits in regard of their use for continuous surveillance
- gain an understanding of seroconversion and antibody levels of patients and survivors
- gain an understanding of the individual antibody and T-cell repertoire of patients and survivors
- study whether patterns of convergent antibody evolution is generated in the surviving population or whether the diseases survivors generated an antibody pool recognizing a specific epitope
- develop the technology to correlate blood antibody levels with levels detected in the saliva
- develop high throughput technologies for the precise detection of immune cell Repertoire and binding epitopes
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
- 是
入选标准
- •tested positive for COVID-19 in Baselland
- •tested negative for COVID-19 in Baselland. Specifically, needed to show symptoms to be able to deduce cross reactivities.
排除标准
- •continuous steroid therapy / chemotherapy / immunsuppressiva
- •subject is treated for cancer
- •severe autoimmune disease
结局指标
主要结局
Qualitative method validation (yes/ no)
时间窗: at baseline
Qualitative method validation: qualitative result of the ELISA (Patient does / does not have immunity) as the gold standard compared to the POC using univariate measures to derive sensitivity and specificity of the POC.
Quantitative method validation (antibody concentrations)
时间窗: at baseline
Quantitative method validation: antibody concentration from the ELISA are related to the dichotomous result from POC.
次要结局
- Immune cell repertoire sequencing(at baseline)
