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Study of the Analytical Performance of Different Salivary Self-collection Methods for the Detection of COVID-19

NCT04550390 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 329

Last updated 2021-03-10

No results posted yet for this study

Summary

Since March 2020, the SARS-CoV type coronavirus infection (SARS-CoV-2; nCoV19; COVID-19) is considered pandemic. As early as April 2020, the World Health Organization recommended the implementation of mass screening of populations, with the aim of identifying cases and contacts and controlling viral spread. Since the end of lock-down on May 11, 2020,the screening policy has been intensified to fight against COVID-19. Virological tests by RT-PCR are thus accessible to all, without a prescription and reimbursed by health insurance. The French government has also set a quantitative target of 1 million tests per week. In order to meet this target, the number of sampling centers has been increased (mobile structures, etc.).

Screening tests are currently carried out using a nasopharyngeal swab analyzed by RT-PCR for the detection of viral RNA. This type of sample has several technical and logistic constraints. It must be carried out by personnel who are authorized and trained in this procedure and in appropriate hospital hygiene practices. It exposes the sampling personnel to possible contamination through nasopharyngeal secretions or coughing that may occur during sampling. With the increase in screening, there are sometimes insufficient numbers of sampling personnel and there is significant market pressure for swabs and virological transport media.

In addition, these swabs are uncomfortable or even painful for the patient, which could imply a reluctance to be screened. They are also complicated in children, whether they are rhino- or oropharyngeal.

An alternative to the nasopharyngeal swab, which is the subject of this project, would be to have one or more reliable sampling methods that are less restrictive than the nasopharyngeal swab ("gold standard"). Thus, we propose to test and compare the results obtained by molecular biology techniques on nasopharyngeal, salivary and buccal swabs.

Conditions

  • SARS-CoV Infection

Interventions

DIAGNOSTIC_TEST

Saliva collection

2 saliva samples are self-collected by participants

Sponsors & Collaborators

  • Direction Centrale du Service de Santé des Armées

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2020-10-19
Completion
2020-10-19

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 NCT04550390 on ClinicalTrials.gov