NCT04859023

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

Comparison of Strategies Based on RT-PCR or Antigenic Test for the Screening of SARS-CoV-2 Infection in General Population Using Self-samples (COVID-19).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10,000 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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).

Conditions

• SARS-CoV Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	saliva sample combined to an anterior nare self-swabbing (Self-samples)	Tested by antigenic test.
DIAGNOSTIC_TEST	saliva sample (Self-sample)	Tested by RT-PCR.
OTHER	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.
OTHER	Survey of acceptability of the different self-samples.	collection of : assessment and acceptability of the tolerance of self-samples.

Timeline

• Start date: 2021-02-22
• Primary completion: 2021-02-28
• Completion: 2021-02-28
• First posted: 2021-04-26
• Last updated: 2021-05-06

Locations

1 site across 1 country: France