NCT04712175

Diagnostic Validation of Rapid Detection of the COVID-19 Causative Virus (SARS-CoV-2) in Saliva Samples by Mass Spectrometry

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Nasopharyngeal sampling	Swabs will be taken of nasopharyngeal samples for RT-PCR
DIAGNOSTIC_TEST	Saliva sampling	A 10ml saliva sample will collected in a sterile 60ml bottle for mass spectrometry and RT-PCR

Timeline

• Start date: 2021-03-04
• Primary completion: 2022-12-31
• Completion: 2023-12-18
• First posted: 2021-01-15
• Last updated: 2023-12-29

Locations

1 site across 1 country: France