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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04712175

Acronym

SALICOV

Enrollment

250

Registered

2021-01-15

Start date

2021-03-04

Completion date

2023-12-18

Last updated

2023-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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.

Interventions

DIAGNOSTIC_TESTNasopharyngeal sampling

Swabs will be taken of nasopharyngeal samples for RT-PCR

DIAGNOSTIC_TESTSaliva sampling

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026