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

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

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV Infection
• Intervention / Treatment: Diagnostic test: Saliva collection

• Study Type: Observational
• Enrollment (Actual): 329

Contacts and Locations

Study Locations

• France
  • Clamart, France, 92141
    • Hopital D'Instruction Des Armees Percy
  • Marseille, France, 13384
    • Hôpital d'Instruction des Armées Laveran
  • Saint-Mandé, France, 94160
    • Hôpital d'Instruction des Armées BEGIN
  • Toulon, France, 83000
    • Hôpital d'instruction des armées Sainte-Anne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population is composed of people coming for COVID-19 screening to one of the four military training hospitals involved,either spontaneously or during cluster investigations.

Patients hospitalized in these hospitals with non-severe illness and symptoms related to COVID-19 for less than 7 days will also be eligible to the study.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative result of molecular tests for the SARS-CoV-2 virus.	Qualitative result may be : "positive", "negative" or "invalid". The test results will be compared between the two types of collection method.	At enrollment (day 1)

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): October 19, 2020
• Study Completion (Actual): October 19, 2020

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Severe Acute Respiratory Syndrome
• Other Study ID Numbers: 2020-COVID19-36; 2020-A02536-33 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No