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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10,000
Tested by antigenic test.
Tested by RT-PCR.
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.
collection of : assessment and acceptability of the tolerance of self-samples.
CHU Saint-Etienne
Saint-Etienne, France
Positivity of self-samples combining saliva and anterior nare specimens tested by rapid antigenic test compared to saliva tested by RT-PCR (gold-standard).
Measured by antigenic test results and RT-PCR results.
Time frame: Day: 7
Number and percentage of SARS-CoV-2 infection in the selected population tested by reference RT-PCR on saliva
Measured by RT-PCR results.
Time frame: Day: 7
Number and percentage of the circulation of different variants of interest of SARS-CoV-2 viruses in the tested population
Measured by RT-PCR results.
Time frame: Day: 7
Evaluate the acceptability (pain, discomfort, speed of execution) of self-samples according to age and socio-professional categories
Measured by survey of acceptability of the different self-samples results.
Time frame: Day: 7
Evaluate the cost-effectiveness ratio of the new strategy by comparison to the gold standard (RT-PCR on saliva)
Measured by number of test performed and performances of self-samples combining saliva and anterior nare specimens tested by rapid antigenic test compared to saliva tested by RT-PCR.
Time frame: Day: 7
Number of people who have benefited from sensitization and support specifically set up as part of the screening campaign
Measured the screening day.
Time frame: Day: 7
Number of persons cared for by the territorial isolation support cell (CTAI)
Measured the screening day.
Time frame: Day: 7
Health literacy questionnaire
It is a questionnaire with items on the transmission of the virus and barrier gestures, adherence to barrier gestures, modalities of isolation in case of positivity and motivations for participating in this screening campaign.
Time frame: Day: 7
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