Comparison of Detection of SARS-CoV2 (COVID-19) Between Nasopharyngeal Swab Specimens and Those Obtained by Salivary Sputum (COVISAL)

Comparison of the Results, Feasibility and Acceptability of Molecular Detection of SARS-CoV2 Between Nasopharyngeal Swab Specimens Recovered in Virological Transport Medium and Those Obtained by Salivary Sputum

Multicenter observational study of diagnostic test validation (Research Involving the Human Person, type 3) In addition to the diagnosis by the reference method (nasopharyngeal swab), the patient will be asked to provide a saliva sample via a salivary spit. The clinical circumstances of the diagnosis, the age of the patient, the associated terrain (diabetes, immunodepression, pregnancy) will be noted. The nasopharyngeal and saliva samples will be analyzed in Cayenne and the remaining samples will be frozen and stored at the CRB before being sent to the University Hospital of Caen for analysis and concordance verification.

The expected benefits are:

Possibility of repeating tests in the same person more easily due to the absence of pain and thus reduce the barriers to diagnosis and screening.

Possibility of self-sampling, which could simply be sent to the laboratory, which would relieve the diagnostic sites that mobilize staff and require a fairly heavy organization. Avoid long waiting lines that can be an obstacle and lead to a renunciation of the diagnosis.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: Salivary test for COVID19

• Study Type: Interventional
• Enrollment (Actual): 1159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• French Guiana
  • Cayenne, French Guiana, 97306
    • General Hospital of Cayenne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient with an indication to perform a COVID diagnostic test (symptomatology, contact case, systematic screening etc...)
• Men and women at least 3 years old

Exclusion Criteria:

• Refusal of the patient or his legal representative,
• Taking treatments that reduce salivary volume (anticholinergic activity)
• Impossibility to perform the nasopharyngeal test
• Patient under guardianship or curatorship, persons placed under protective measures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient with an indication for a COVID19 test; The persons included will be those who have an indication for a COVID 19 test and who present themselves at the Cayenne hospital and during the screening missions organised by the Red Cross and Médecin du Monde during the COVID 19 epidemic in the territory	Diagnostic test: Salivary test for COVID19; Results of nasopharyngeal and salivary samples taken at the Cayenne hospital and the Caen university center,; Pre-analytical particularities and analytical particularities; Cycle threeshold; Demographic variables; Clinical variables; Clinical criteria; Questionnaire on the perception of the 2 sampling methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity of salivary test vs. nasopharyngeal test	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
- Proportion of analyses not performed on salivary samples for the following reasons (vs. number of salivary sample analyses performed): o Insufficient quantity of biological sample, o Inability to collect the sample		1 day
Perception of the tests by questionnaire (proportion of positive opinions)		1 day
Perception of the tests by questionnaire (proportion of negative opinions)		1 day
Positivity and negativity of the salivary test vs. symptomatology and associated terrain		1 day
Sensitivity and specificity analysis between the salivary test and the nasopharyngeal test according to the clinical context	Sensitivity and specificity analysis between the salivary test and the nasopharyngeal test according to the time between the samples and the onset of symptoms, the time between the samples and the contact with an index case, the known immunodepression and the clinical context (diabetes, pregnancy)	1 day
Description of the aspect of the saliva collected: mucous or fluid	Description of the analytical criteria of the saliva sample	1 day
Volume of saliva collected (mL)	Description of the analytical criteria of the saliva sample: (pipette measurement, if the saliva is not fluid, pipette measurement after vortexing for 1 min)	1 day
Description of the analytical criteria of the saliva sample:pre-analytical treatments if necessary		1 day
Number of Cycle threeshold for the first analysis (done at the Cayenne hospital) and the second analysis (done at the university hospital of Caen)		1 day
- Sensitivity of salivary test vs nasopharyngeal test with strong positives (3 genes detected)		1 day
- Specificity of salivary test vs nasopharyngeal test with strong positives (3 genes detected)		1 day
- Sensitivity of salivary test vs nasopharyngeal test with weak positives (1 gene detected)		1 day
- Specificity of salivary test vs nasopharyngeal test with weak positives (1 gene detected)		1 day

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Cayenne

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2020
• Primary Completion (Actual): November 12, 2020
• Study Completion (Anticipated): November 12, 2021

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 26, 2021
• Last Verified: August 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; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: COVISAL

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