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

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: Nasopharyngeal sampling; Diagnostic test: Saliva sampling

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• France
  • Nîmes, France
    • CHU de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults presenting to the Walk-in Center for Emerging Biological Risks of the Nîmes University Hospital for screening for SARS-CoV-2 infection or who are hospitalized at the Infectious and Tropical Diseases Department for severe infection with SARS-CoV-2.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with SARS-CoV-2 infection	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
Patients without SARS-CoV-2 infection	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of SARS-CoV-2 on saliva samples via RT-PCR	RT-PCR	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Collaborators: Technological Innovations for Detection and Diagnosis Laboratory
• Investigators: Principal Investigator: Albert Sotto, Centre Hospitalier Universitaire de Nimes

Publications and helpful links

General Publications

• Gouveia D, Miotello G, Gallais F, Gaillard JC, Debroas S, Bellanger L, Lavigne JP, Sotto A, Grenga L, Pible O, Armengaud J. Proteotyping SARS-CoV-2 Virus from Nasopharyngeal Swabs: A Proof-of-Concept Focused on a 3 Min Mass Spectrometry Window. J Proteome Res. 2020 Nov 6;19(11):4407-4416. doi: 10.1021/acs.jproteome.0c00535. Epub 2020 Aug 5.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 18, 2023

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: LOCAL-COVID/2020/AS-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No