Detection of COVID-19 in Saliva Collection (SALICOV)

Evaluation of the Performance of a Saliva Sample Versus a Nasopharyngeal Sample in the Diagnosis of COVID-19 by RT-PCR

Since December 2019, the world has faced a pandemic of COVID-19, an infectious disease caused by SARS-CoV-2, a virus that emerged in China. The reference diagnosis is based on the search for the SARS-COV-2 genome in the nasopharyngeal sample.

Carrying out this sample requires the competence of a healthcare professional and presents some inconveniences for the tested patient. Because saliva collection is simple, non-invasive, painless and inexpensive, and can be performed by poorly trained personnel, it could be an alternative to the reference nasopharyngeal sample. SARS-CoV2 detection in human saliva could be a potential diagnosis of COVID infection.

Study Overview

• Status: Completed
• Conditions: Sars-CoV2; RT-PCR; Saliva Collection; Nasopharyngeal Sample

• Study Type: Observational
• Enrollment (Actual): 501

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80480
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult ambulatory patients screened for SARS Cov 19 at the CHU Amiens COViD clinic will be included in the study. A double sample will be taken from the saliva and the nasopharynx in parallel using the same sample kit. This double sampling has no direct impact on conventional patient management.

Description

Inclusion Criteria:

• patient hospitalized at the Amiens CHU in a COVID-19 unit
• patient seen as outpatient in the area of infectious pathologies for COVID-19 infection

Exclusion Criteria:

• Patients under 18
• patients under guardianship or curators

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of SARS-CoV-2 RNA in the saliva sample	Detection of SARS-CoV-2 RNA in the saliva sample	day 1
Concordance between the Saliva sample and the nasonasopharyngeal sample SARS-CoV-2 RT-PCR results	Concordance between the Saliva sample and the nasonasopharyngeal sample SARS-CoV-2 RT-PCR results	day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2020
• Primary Completion (Actual): August 5, 2020
• Study Completion (Actual): August 5, 2020

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: RT-PCR; Sars-CoV2; Saliva collection; nasopharyngeal sample
• Other Study ID Numbers: PI2020_843_0045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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