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临床试验/NCT04712175
NCT04712175已完成不适用

Validation Diagnostique de la détection Rapide du Virus SARS-CoV-2 Dans Des échantillons Salivaires Par spectrométrie de Masse

Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2021年3月4日最近更新:
适应症

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

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)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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