CORDAGES: Severe Acute Respiratory Syndrome Coronavirus 2 (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

Location

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 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 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, the investigators 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 Disease	Intervention/Treatment	Phase
SARS-CoV-2 COVID-19	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:

Severe Acute Respiratory Syndrome Coronavirus 2 (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

Arm	Intervention/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

Arm

Intervention/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

Proportion of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive patients for the two different sampling types (buccal vs nasopharyngeal) and two methods (ELISA POCT vs RT-PCR) [48 Hours]
Number of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive patients by sampling type (buccal and nasopharyngeal swab) and analytical method (ELISA POCT vs RT-PC)

Secondary Outcome Measures

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