Comparison of the Results, Feasibility and Acceptability of Molecular Detection of SARS-CoV2 Between Nasopharyngeal Swab Specimens Recovered in Virological Transport Medium and Those Obtained by Salivary Sputum
试验速览
- 阶段
- 不适用
- 入组人数
- 1,159
- 试验地点
- 2
- 主要终点
- Sensitivity of salivary test vs. nasopharyngeal test
研究概览
简要总结
Multicenter observational study of diagnostic test validation (Research Involving the Human Person, type 3) In addition to the diagnosis by the reference method (nasopharyngeal swab), the patient will be asked to provide a saliva sample via a salivary spit. The clinical circumstances of the diagnosis, the age of the patient, the associated terrain (diabetes, immunodepression, pregnancy) will be noted. The nasopharyngeal and saliva samples will be analyzed in Cayenne and the remaining samples will be frozen and stored at the CRB before being sent to the University Hospital of Caen for analysis and concordance verification.
The expected benefits are:
Possibility of repeating tests in the same person more easily due to the absence of pain and thus reduce the barriers to diagnosis and screening.
Possibility of self-sampling, which could simply be sent to the laboratory, which would relieve the diagnostic sites that mobilize staff and require a fairly heavy organization. Avoid long waiting lines that can be an obstacle and lead to a renunciation of the diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with an indication to perform a COVID diagnostic test (symptomatology, contact case, systematic screening etc...)
- •Men and women at least 3 years old
排除标准
- •Refusal of the patient or his legal representative,
- •Taking treatments that reduce salivary volume (anticholinergic activity)
- •Impossibility to perform the nasopharyngeal test
- •Patient under guardianship or curatorship, persons placed under protective measures
结局指标
主要结局
Sensitivity of salivary test vs. nasopharyngeal test
时间窗: 1 day
次要结局
- - Proportion of analyses not performed on salivary samples for the following reasons (vs. number of salivary sample analyses performed): o Insufficient quantity of biological sample, o Inability to collect the sample(1 day)
- Perception of the tests by questionnaire (proportion of positive opinions)(1 day)
- Positivity and negativity of the salivary test vs. symptomatology and associated terrain(1 day)
- - Sensitivity of salivary test vs nasopharyngeal test with strong positives (3 genes detected)(1 day)
- Description of the aspect of the saliva collected: mucous or fluid(1 day)
- Perception of the tests by questionnaire (proportion of negative opinions)(1 day)
- Description of the analytical criteria of the saliva sample:pre-analytical treatments if necessary(1 day)
- Number of Cycle threeshold for the first analysis (done at the Cayenne hospital) and the second analysis (done at the university hospital of Caen)(1 day)
- - Sensitivity of salivary test vs nasopharyngeal test with weak positives (1 gene detected)(1 day)
- Sensitivity and specificity analysis between the salivary test and the nasopharyngeal test according to the clinical context(1 day)
- Volume of saliva collected (mL)(1 day)
- - Specificity of salivary test vs nasopharyngeal test with strong positives (3 genes detected)(1 day)
- - Specificity of salivary test vs nasopharyngeal test with weak positives (1 gene detected)(1 day)