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

Centre Hospitalier de Cayenne

Status: Unknown

Conditions: Covid19

Treatments: Diagnostic Test: Salivary test for COVID19

Study type: Interventional

Funder types: Other

Identifiers

NCT05024461

COVISAL

Details and patient eligibility

About

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.

Enrollment: 1,159 patients

Sex: All

Ages: 3+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,159 participants in 1 patient group

Patient with an indication for a COVID19 test

Experimental group

Description:

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

Treatment:

Diagnostic Test: Salivary test for COVID19