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

SARS-CoV Infection Clinical Trial

— AutoCoV  

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04859023
• Other study ID #: 21CH037
• Secondary ID: 2021-A00390-41
• Status: Completed
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: February 28, 2021

Study information

• Verified date: May 2021
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10000
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Diagnostic Test:
• saliva sample combined to an anterior nare self-swabbing (Self-samples)
Tested by antigenic 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.
• Survey of acceptability of the different self-samples.
collection of : assessment and acceptability of the tolerance of self-samples.

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day: 7
Secondary	Number and percentage of SARS-CoV-2 infection in the selected population tested by reference RT-PCR on saliva	Measured by RT-PCR results.	Day: 7
Secondary	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.	Day: 7
Secondary	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.	Day: 7
Secondary	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.	Day: 7
Secondary	Number of people who have benefited from sensitization and support specifically set up as part of the screening campaign	Measured the screening day.	Day: 7
Secondary	Number of persons cared for by the territorial isolation support cell (CTAI)	Measured the screening day.	Day: 7
Secondary	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.	Day: 7