Use of Rapid Covid-19 Antibody Test Marketed by AAZ Laboratories in Healthcare Workers Presumably Being Infected by SARS-CoV-2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- To assess the predictive value of Covid-19 rapid test
研究概览
简要总结
The study objectives were to assess 1/the immune status of healthcare professionals with suggestive symptomatology of Covid-19 infection and 2/the sensitivity and specificity of AAZ rapid test by comparing it with a serological ELISA test.
An open-label, monocentric, prospective, non-randomized study, is conducted, including 50 hospital healthcare professionals and 50 private health professionals.
Knowledge of serostatus will achieve the implementation of a strategy of management of patients according to specific immunity of health professionals
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Healthcare professionals with symptoms suggestive of Covid-19 infection
排除标准
- •any other subject
- •pregnant women
- •protected adult
结局指标
主要结局
To assess the predictive value of Covid-19 rapid test
时间窗: One week
Comparative study with Elisa Test
Compare the results of rapid tests on serum and capillary samples
时间窗: one week
Performance evaluation of rapid tests according to the samples used
次要结局
- A posteriori diagnosis of a covid-19 recent infection with suggestive symptomatology(one week)
- Analysis of factors associated with negativity of PCR test on oropharyngeal swabs and positive serology(One week)