CORDAGES: SARS-CoV-2 Buccal Screening Evaluation Using an RT-PCR Assay and a Rapid ELISA Test Among Symptomatic and Asymptomatic Patients

Sponsor
Centre Scientifique de Monaco (Other)
Overall Status
Recruiting
CT.gov ID
NCT05074745
Collaborator
Department of Health Affairs, Monaco (Other)
1,500
Enrollment
1
Location
1
Arm
10.3
Anticipated Duration (Months)
144.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective is to expand screening for SARS-CoV2 by evaluating the diagnostic accuracy of the RT-PCR test (Cobas® Roche, Switzerland) and the ELISA Point of Contact Testing (PORTABLE COVID-19 ANTIGEN LAB® Stark, Italy) on buccal swab compared to the reference test, the RT-PCR test (Cobas® Roche, Switzerland) on nasopharyngeal swab.

Secondary objectives

  • To evaluate the diagnostic accuracy of oral swab RT-PCR and POCT relative to the quantitative amplification (Ct) values of the NP Swab RT-PCR assay.

  • Analyze RT-PCR amplification cycle thresholds (Ct) and POCT diagnostic accuracy as a function of the presence and timing of symptoms.

  • Among symptomatic participants, compare clinical presentations between positive and negative participants on the NP swab RT-PCR test.

  • The RT-PCR test may be imperfectly sensitive, ranging from 71 to 98%3. Using a Bayesian latent class model, we will assess the true accuracy of POCT as it does not require the assumption that any one test or combination of tests is perfect14,15.

Condition or DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: ELISA POCT vs RT-PCR
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Monocentric, Prospective, 3 components Nasopharyngeal swab by PCR Buccal swab by PCR Buccal by ELISA POCTMonocentric, Prospective, 3 components Nasopharyngeal swab by PCR Buccal swab by PCR Buccal by ELISA POCT
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
SARS-CoV-2 Buccal Screening Evaluation Using an RT-PCR Assay and a Rapid ELISA Test Among Symptomatic and Asymptomatic Patients: the CORDAGES Study
Actual Study Start Date :
Feb 18, 2021
Anticipated Primary Completion Date :
Dec 30, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Buccal and nasopharyngeal swabs

One patient will have 3 swabs taken, 2 buccal for PCR and ELISA POCT, 1 nasopharyngeal for PCR

Diagnostic Test: ELISA POCT vs RT-PCR
3 swabs taken, buccal for RT-PCR and ELISA POCT, nasopharyngeal for RT-PCR

Outcome Measures

Primary Outcome Measures

  1. Proportion of SARS-CoV-2 positive patients for the two different sampling types (buccal vs nasopharyngeal) and two methods (ELISA POCT vs RT-PCR) [48 Hrs]

    Number of SARS-CoV-2 positive patients by sampling type (buccal and nasopharyngeal swab) and analytical method (ELISA POCT vs RT-PC)

Secondary Outcome Measures

  1. Comparison of Ct values in buccal and nasopharyngeal swabs [48 Hrs]

    Ct values by PCR in buccal and nasopharyngeal swabs

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 18+ patient eligible for COVID-19 testing in Monaco

  • symptoms suggestive of COVID-19

  • contact with a confirmed case of COVID-19

Exclusion Criteria:
  • refusal to participate in the study

  • preventive screening of professional groups

  • inability to return to the screening center within 48-72 hours of the first visit.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Centre National de Depistage - Espace Leo FerreMonacoMonaco98000

Sponsors and Collaborators

  • Centre Scientifique de Monaco
  • Department of Health Affairs, Monaco

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Scientifique de Monaco
ClinicalTrials.gov Identifier:
NCT05074745
Other Study ID Numbers:
  • PRO_CSM_01_2021
First Posted:
Oct 12, 2021
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Scientifique de Monaco
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2021