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

Study Overview
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Brief Summary
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Diagnostic Test: Nasopharyngeal sampling
* Diagnostic Test: Saliva sampling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with SARS-CoV-2 infection<br> | Diagnostic Test: Nasopharyngeal sampling<br>* Swabs will be taken of nasopharyngeal samples for RT-PCR<br>Diagnostic Test: Saliva sampling<br>* A 10ml saliva sample will collected in a sterile 60ml bottle for mass spectrometry and RT-PCR<br>|
| Patients without SARS-CoV-2 infection<br> | Diagnostic Test: Nasopharyngeal sampling<br>* Swabs will be taken of nasopharyngeal samples for RT-PCR<br>Diagnostic Test: Saliva sampling<br>* A 10ml saliva sample will collected in a sterile 60ml bottle for mass spectrometry and RT-PCR<br>|

What is the study measuring?
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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 |