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

NCT04859023 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10000

Last updated 2021-05-06

No results posted yet for this study

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.

Conditions

  • SARS-CoV Infection

Interventions

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Bruno POZZETTO, MD PhD · CHU SAINT-ETIENNE

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-22
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04859023 on ClinicalTrials.gov