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

NCT04712175 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2023-12-29

No results posted yet for this study

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.

Conditions

  • Covid19

Interventions

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

Sponsors & Collaborators

  • Technological Innovations for Detection and Diagnosis Laboratory

    collaborator UNKNOWN
  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Albert Sotto · Centre Hospitalier Universitaire de Nīmes

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-04
Primary Completion
2022-12-31
Completion
2023-12-18

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04712175 on ClinicalTrials.gov