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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Covid19

Treatments: Diagnostic Test: Saliva sampling; Diagnostic Test: Nasopharyngeal sampling

Study type: Observational

Funder types: Other

Identifiers

NCT04712175

LOCAL-COVID/2020/AS-01

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 2 patient groups

Patients with SARS-CoV-2 infection

Treatment:

Diagnostic Test: Saliva sampling

Diagnostic Test: Nasopharyngeal sampling

Patients without SARS-CoV-2 infection

Treatment:

Diagnostic Test: Saliva sampling

Diagnostic Test: Nasopharyngeal sampling