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

Completed

• Conditions: Covid19
• Interventions: Diagnostic Test: Nasopharyngeal sampling; Diagnostic Test: Saliva sampling

• Registration Number: NCT04712175
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-15
• Study Start: 2021-03-04
• Primary Completion: 2022-12-31
• Status Verified: 2023-12
• Study Completion: 2023-12-18
• Last Update Submitted: 2023-12-28
• Last Update Posted: 2023-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with SARS-CoV-2 infection	Nasopharyngeal sampling	-
Patients with SARS-CoV-2 infection	Saliva sampling	-
Patients without SARS-CoV-2 infection	Nasopharyngeal sampling	-
Patients without SARS-CoV-2 infection	Saliva sampling	-

Primary Outcome Measures

Name	Time	Method
Detection of SARS-CoV-2 on a saliva samples by mass spectrometry	Day 0	tandem mass spectrometry test
Detection of SARS-CoV-2 on nasopharyngeal samples (gold standard)	Day 0	RT-PCR

Secondary Outcome Measures

Name	Time	Method
Detection of SARS-CoV-2 on saliva samples via RT-PCR	Day 0	RT-PCR

Trial Locations

Locations (1)

CHU de Nîmes; 🇫🇷 Nîmes, France