Comparison of Strategies Based on RT-PCR or Antigenic Test for the Screening of SARS-CoV-2 Infection in General Population Using Self-samples (COVID-19).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Positivity of self-samples combining saliva and anterior nare specimens tested by rapid antigenic test compared to saliva tested by RT-PCR (gold-standard).
研究概览
简要总结
The virological diagnosis of SARS-CoV-2 infection is pivotal for the control of the outbreak by large screening of a- or pauci-symptomatic subjects. Despite nasopharyngeal swabbing tested by RT-PCR is considered as the gold standard, new strategies based on self-samples are considered as valuable alternatives because of their non-invasiveness and ability to be performed in the absence healthcare worker, especially when the subject is asymptomatic and needs to be tested repetitively. The aim of the present project is to evaluate two strategies both based on self-samples: (i) a saliva sample combined to an anterior nare self-swabbing tested by antigenic test versus (ii) a saliva sample tested by RT-PCR. The comparison will be performed during a mass screening of the population of the city of Saint-Etienne (170000 inhabitants), France. The sensitivity of the rapid antigenic test will be evaluated in comparison to that of RT-PCR considered as gold standard.
详细描述
The main objective is to evaluate the performance of a strategy for screening for CoV-2-SARS infection that would combine 1) a salivary self-sample with an anterior nasal swab and 2) a diagnostic antigenic test, in comparison with the reference salivary RT-PCR technique recently validated by National Authority for Health (HAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult age or at least 10 year old able to perform self-sampling of saliva and anterior nare swabbing
- •Subject or legal tutor agreeing to participate to self-sampling and to collect anonymized data required by the present research
排除标准
- •Inability to understand the protocol (language barrier notably)
- •Deny to participate to the proposed research
- •Patients under tutorship
结局指标
主要结局
Positivity of self-samples combining saliva and anterior nare specimens tested by rapid antigenic test compared to saliva tested by RT-PCR (gold-standard).
时间窗: Day: 7
Measured by antigenic test results and RT-PCR results.
次要结局
- Number and percentage of SARS-CoV-2 infection in the selected population tested by reference RT-PCR on saliva(Day: 7)
- Number and percentage of the circulation of different variants of interest of SARS-CoV-2 viruses in the tested population(Day: 7)
- Number of persons cared for by the territorial isolation support cell (CTAI)(Day: 7)
- Number of people who have benefited from sensitization and support specifically set up as part of the screening campaign(Day: 7)
- Health literacy questionnaire(Day: 7)
- Evaluate the acceptability (pain, discomfort, speed of execution) of self-samples according to age and socio-professional categories(Day: 7)
- Evaluate the cost-effectiveness ratio of the new strategy by comparison to the gold standard (RT-PCR on saliva)(Day: 7)