Comparison of Strategies Based on RT-PCR or Antigenic Test for the Screening of SARS-CoV-2 Infection (COVID-19). (AutoCoV)

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: SARS-CoV Infection

Treatments: Other: Survey of acceptability of the different self-samples.; Other: Survey of SARS-COV-19 knowledge; Diagnostic Test: saliva sample combined to an anterior nare self-swabbing (Self-samples); Diagnostic Test: saliva sample (Self-sample)

Study type: Interventional

Funder types: Other

Identifiers

NCT04859023

2021-A00390-41 (Other Identifier)

21CH037

Details and patient eligibility

About

The virological diagnosis of SARS-CoV-2 infection is pivotal for the control of the outbreak by large screening of a- or pauci-symptomatic subjects. Despite nasopharyngeal swabbing tested by RT-PCR is considered as the gold standard, new strategies based on self-samples are considered as valuable alternatives because of their non-invasiveness and ability to be performed in the absence healthcare worker, especially when the subject is asymptomatic and needs to be tested repetitively. The aim of the present project is to evaluate two strategies both based on self-samples: (i) a saliva sample combined to an anterior nare self-swabbing tested by antigenic test versus (ii) a saliva sample tested by RT-PCR. The comparison will be performed during a mass screening of the population of the city of Saint-Etienne (170000 inhabitants), France. The sensitivity of the rapid antigenic test will be evaluated in comparison to that of RT-PCR considered as gold standard.

Full description

The main objective is to evaluate the performance of a strategy for screening for CoV-2-SARS infection that would combine 1) a salivary self-sample with an anterior nasal swab and 2) a diagnostic antigenic test, in comparison with the reference salivary RT-PCR technique recently validated by National Authority for Health (HAS).

Enrollment: 10,000 patients

Sex: All

Ages: 10+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult age or at least 10 year old able to perform self-sampling of saliva and anterior nare swabbing
• Subject or legal tutor agreeing to participate to self-sampling and to collect anonymized data required by the present research

Exclusion criteria

• Inability to understand the protocol (language barrier notably)
• Deny to participate to the proposed research
• Patients under tutorship

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10,000 participants in 1 patient group

mass screening SARS-COV-19

Experimental group

Description:

20 0000 participant will be included during mass screening SARS-COV-19 of the population of the city of Saint-Etienne. They will have two strategies both based on self-samples: (i) a saliva sample combined to an anterior nare self-swabbing tested by antigenic test versus (ii) a saliva sample tested by RT-PCR.

Treatment:

Diagnostic Test: saliva sample combined to an anterior nare self-swabbing (Self-samples)

Other: Survey of acceptability of the different self-samples.

Diagnostic Test: saliva sample (Self-sample)

Other: Survey of SARS-COV-19 knowledge