Evaluation of Quickly Diagnostic Saliva Tests for SARS-CoV-2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 627
- 试验地点
- 2
- 主要终点
- Specific detection of SARS-CoV-2 specific RNA
研究概览
简要总结
Coronavirus disease 2019 or COVID-19 is a highly contagious infectious disease. Symptoms of the disease are non-specific (fever, cough, dyspnea and fatigue), common with many seasonal viruses, which complicates the diagnosis. For mild forms, which represent the vast majority of cases, hospitalization is not necessary and treatment is symptomatic. However in more severe cases, hospitalization is required and sometimes even admission to an intensive care unit.
Several diagnostic tests are already available, but they require, in all cases, the intervention of qualified health personnel to carry out the sample, which includes a risk of contagion and an expensive and time-consuming laboratory analysis and reagents. These tests are therefore not very suitable for massive screenings.
We want to evaluate the performance of a detection test performed on a salivary sample in the diagnosis of SARS-CoV-2. This test will be non-invasive, performed without any analytical device and will restore its qualitative result "infected versus non-infected" in less than 1 hour (30min objective).
详细描述
Study taking place at the Montpellier University Hospital, comparing a salivary sample group with active infection (participants) for SARS-COV2 with a salavary sample tested negative (cured, convalescent and negative) for SARS-COV2 (healthcare workers ,participants)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Control subjects (COV2- group): Participants ( Healthcare staff, patients and DRIVE participants) negative for SARS-CoV-2
- •- Infected subjects (COV2 + group): Patients diagnosed positive for SARS-CoV-2 hospital staff known to be positive and coming to do a control PCR DRIVE participants.
排除标准
- •Eligibility Criteria:
- •Inclusion Criteria:
- •- Control subjects (COV2- group): Healthcare staff presumed and diagnosed negative for SARS-CoV-2
- •- Infected subjects (COV2 + group): Patients diagnosed positive for SARS-CoV-2 hospital staff known to be positive and coming to do a control PCR
- •Exclusion Criteria:
- •Not affiliated with a French Social Security Systemscheme or equivalent system
- •Persons deprived of their liberty, adult protected under guardianship or vulnerable persons
结局指标
主要结局
Specific detection of SARS-CoV-2 specific RNA
时间窗: 1 day
Detection by the LAMP method is to be corroborated with the reference method, RT-PCR on the same salivary sample. Only one sample is taken per subject participating in the study. The sample is divided into two aliquots which will be analyzed by LAMP and RT-PCR
次要结局
- Evaluation of the use of saliva samples compared to nasopharyngeal samples(1 day)
- The correlation between the measurement of the assayed viral load (CT value) by the standard method and by the LAMP developed by SYS2DIAG / SKILLCELL.(1 day)
- Analytical sensitivity of the LAMP test.(1 day)