Evaluation of Quickly Diagnostic Saliva Tests for SARS-CoV-2 (EasyCoV)

University Hospital Center (CHU)

Status

Completed

Conditions

SARS-CoV-2

Treatments

Diagnostic Test: Sampling salivary

Study type

Observational

Funder types

Other

Identifiers

NCT04337424

RECHMPL20_0170

Details and patient eligibility

About

Coronavirus disease 2019 or COVID-19 is a highly contagious infectious disease. Symptoms of the disease are non-specific (fever, cough, dyspnea and fatigue), common with many seasonal viruses, which complicates the diagnosis. For mild forms, which represent the vast majority of cases, hospitalization is not necessary and treatment is symptomatic. However in more severe cases, hospitalization is required and sometimes even admission to an intensive care unit.

Several diagnostic tests are already available, but they require, in all cases, the intervention of qualified health personnel to carry out the sample, which includes a risk of contagion and an expensive and time-consuming laboratory analysis and reagents. These tests are therefore not very suitable for massive screenings.

We want to evaluate the performance of a detection test performed on a salivary sample in the diagnosis of SARS-CoV-2. This test will be non-invasive, performed without any analytical device and will restore its qualitative result "infected versus non-infected" in less than 1 hour (30min objective).

Full description

Study taking place at the Montpellier University Hospital, comparing a salivary sample group with active infection (participants) for SARS-COV2 with a salavary sample tested negative (cured, convalescent and negative) for SARS-COV2 (healthcare workers ,participants)

Enrollment

627 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Control subjects (COV2- group): Participants ( Healthcare staff, patients and DRIVE participants) negative for SARS-CoV-2
Infected subjects (COV2 + group): Patients diagnosed positive for SARS-CoV-2 hospital staff known to be positive and coming to do a control PCR DRIVE participants.

Exclusion criteria

Eligibility Criteria:

Inclusion Criteria:

Control subjects (COV2- group): Healthcare staff presumed and diagnosed negative for SARS-CoV-2
Infected subjects (COV2 + group): Patients diagnosed positive for SARS-CoV-2 hospital staff known to be positive and coming to do a control PCR

Exclusion Criteria:

Not affiliated with a French Social Security Systemscheme or equivalent system
Persons deprived of their liberty, adult protected under guardianship or vulnerable persons