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

NCT ID: NCT04712175

Last Updated: 2023-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-04

Study Completion Date

2023-12-18

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.

Detailed Description

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Conditions

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Covid19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with SARS-CoV-2 infection

Nasopharyngeal sampling

Intervention Type DIAGNOSTIC_TEST

Swabs will be taken of nasopharyngeal samples for RT-PCR

Saliva sampling

Intervention Type DIAGNOSTIC_TEST

A 10ml saliva sample will collected in a sterile 60ml bottle for mass spectrometry and RT-PCR

Patients without SARS-CoV-2 infection

Nasopharyngeal sampling

Intervention Type DIAGNOSTIC_TEST

Swabs will be taken of nasopharyngeal samples for RT-PCR

Saliva sampling

Intervention Type DIAGNOSTIC_TEST

A 10ml saliva sample will collected in a sterile 60ml bottle for mass spectrometry and RT-PCR

Interventions

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Nasopharyngeal sampling

Swabs will be taken of nasopharyngeal samples for RT-PCR

Intervention Type DIAGNOSTIC_TEST

Saliva sampling

A 10ml saliva sample will collected in a sterile 60ml bottle for mass spectrometry and RT-PCR

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technological Innovations for Detection and Diagnosis Laboratory

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Albert Sotto

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nīmes

Locations

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CHU de Nîmes

Nîmes, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 32697082 (View on PubMed)

Other Identifiers

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LOCAL-COVID/2020/AS-01

Identifier Type: -

Identifier Source: org_study_id