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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-22

Study Completion Date

2021-02-28

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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SARS-CoV Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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mass screening SARS-COV-19

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.

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

Tested by antigenic test.

saliva sample (Self-sample)

Intervention Type DIAGNOSTIC_TEST

Tested by RT-PCR.

Survey of SARS-COV-19 knowledge

Intervention Type OTHER

collection of : socio-professional characteristics, questions on health literacy on the transmission of the virus and barrier gestures, adherence to barrier gestures, isolation modalities in case of positivity, motivations for participating in this screening campaign.

Survey of acceptability of the different self-samples.

Intervention Type OTHER

collection of : assessment and acceptability of the tolerance of self-samples.

Interventions

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

Tested by antigenic test.

Intervention Type DIAGNOSTIC_TEST

saliva sample (Self-sample)

Tested by RT-PCR.

Intervention Type DIAGNOSTIC_TEST

Survey of SARS-COV-19 knowledge

collection of : socio-professional characteristics, questions on health literacy on the transmission of the virus and barrier gestures, adherence to barrier gestures, isolation modalities in case of positivity, motivations for participating in this screening campaign.

Intervention Type OTHER

Survey of acceptability of the different self-samples.

collection of : assessment and acceptability of the tolerance of self-samples.

Intervention Type OTHER

Eligibility Criteria

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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