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

NCT ID: NCT04550390

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 329 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2020-10-19

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Saliva collection

2 saliva samples are self-collected by participants

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• To be at least 18 years of age
• To come at hospital for SARS-CoV-2 screening
• To be able to receive a nasopharyngeal swab

Exclusion Criteria

• People under 18 years of age
• Inpatient in intensive care
• Pregnant or breastfeeding woman
• Individual with dry syndrome (Gougerot-Sjögren syndrome)
• Taking treatments that reduce salivary volume (anticholinergic activity)
• People with a COVID-19 diagnosis confirmed by a molecular biology method >7 days ago
• Contraindication to oral swabbing

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Direction Centrale du Service de Santé des Armées

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital d'Instruction des Armées Percy

Clamart, , France

Hôpital d'Instruction des Armées Laveran

Marseille, , France

Hôpital d'Instruction des Armées Bégin

Saint-Mandé, , France

Hôpital d'Instruction des Armées Sainte-Anne

Toulon, , France

Countries

France

Other Identifiers

2020-A02536-33

Identifier Type: OTHER

Identifier Source: secondary_id

2020-COVID19-36

Identifier Type: -

Identifier Source: org_study_id