Validation Diagnostique de la détection Rapide du Virus SARS-CoV-2 Dans Des échantillons Salivaires Par spectrométrie de Masse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Detection of SARS-CoV-2 on a saliva samples by mass spectrometry
研究概览
简要总结
In order to control the COVID-19 pandemic, a policy for the diagnosis and screening of people likely to be infected with SARS-CoV-2 has been established The reference diagnostic test is RT-PCR on nasopharyngeal swab. Nasopharyngeal swabbing requires training, generates a risk of aerosolization and therefore viral transmission to the operator, and is unpleasant or even painful for the patient. RT-PCR is efficient, but time-consuming. It is therefore necessary to consider techniques that are less subject to difficulties of production and sampling, and less time-consuming. Tandem mass spectrometry on saliva samples is a promising option. A combined "mass spectrometry/saliva test" should provide faster results.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must not have opposed their inclusion in the study
- •Patient presenting to the Walk-in Center for Emerging Biological Risks for SARS-CoV-2 screening by nasopharyngeal swab OR hospitalized in the Infectious and Tropical Diseases Department for severe SARS-CoV-2 infection, diagnosed by RT-PCR on nasopharyngeal sample, taken at Nîmes University Hospital, in the previous 24 hours.
排除标准
- •Patient already included in the study
- •The subject is in a period of exclusion determined by a previous study
- •It is impossible to give the subject clear information
- •The patient is under safeguard of justice or state guardianship
- •Patient unable to give consent
结局指标
主要结局
Detection of SARS-CoV-2 on a saliva samples by mass spectrometry
时间窗: Day 0
tandem mass spectrometry test
Detection of SARS-CoV-2 on nasopharyngeal samples (gold standard)
时间窗: Day 0
RT-PCR
次要结局
- Detection of SARS-CoV-2 on saliva samples via RT-PCR(Day 0)
