Evaluation du Test " Sofia SARS Antigen FIA Assay " Dans le Cadre du dépistage de la COVID-19
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- assessment Vs gold standard
研究概览
简要总结
Evaluating the performance of the Sofia SARS Antigen FIA
详细描述
RT-PCR is the reference technique for the diagnosis of COVID-19, as recommended by WHO, ECDC and the HAS College.
Serological tests to identify antibodies developed by the immune system following infection with SARS-CoV-2 are not currently recommended as a first-line test for the initial diagnosis of COVID-19. However, they can be used in cases of negative RT-PCR and suggestive clinical presentation, or as a salvage test when RT-PCR could not be performed within 7 days of symptom onset.
Antigenic tests for the detection of SARS-CoV-2 can be used as a first-line test on nasopharyngeal swabs up to and including 4 days after the onset of symptoms. From the 5th day, only detection by gene amplification is indicated. Given their excellent specificity and the current pandemic situation, it is not necessary to confirm positives with a gene amplification test.
However, it is recommended to perform a gene amplification test when the antigenic test result is negative or uninterpretable in symptomatic patients older than 65 years or with at least one risk factor for severe COVID-19.
For contact persons detected in isolation or in clusters, it is also possible to use antigenic tests in the following cases
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
- •Adult patient (> or = 18 years of age)
- •Patient with symptoms of COVID-19 (Rhinitis, throat pain, nasal congestion or other signs of local manifestation of the disease in the upper respiratory tract, including loss of taste, with or without additional systemic symptoms such as fatigue, fever, muscle pain...) whose health condition does not require hospitalization (mild to moderate disease)
- •Patient with these symptoms for 5 days or less with a median of 3 to 4 days.
- •Patient with consent to participate in the study
排除标准
- •Patient with an age below 18 years
- •Patient under legal protection (guardianship, curatorship)
- •Patient without upper respiratory tract symptoms
- •Patients with symptoms for more than 5 days
- •Patient with previous COVID-19 diagnosed by RT-PCR
- •Patient vaccinated against SARS-CoV-2 (1 or 2 injections)
- •Hospitalized patient
- •Refusal to participate
结局指标
主要结局
assessment Vs gold standard
时间窗: Up to 35 positive PCR
PCR results and Ct values for specimens tested are collected and compared with Sofia results.
次要结局
未报告次要终点