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 (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: the CORDAGES Study

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; SARS-CoV-2
• Intervention / Treatment: Diagnostic test: ELISA POCT vs RT-PCR

• Study Type: Interventional
• Enrollment (Anticipated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric VOIGLIO, MD, PhD; Phone Number: +37798984850; Email: evoiglio@gouv.mc

Study Locations

• Monaco
  • Monaco, Monaco, 98000
    • Recruiting
    • Centre National de Depistage - Espace Leo Ferre
    • Contact: Eric VOIGLIO, MD, PhD; Phone Number: +37798984850; Email: evoiglio@gouv.mc
    • Contact: Thomas ALTHAUS, MD, PhD; Email: talthaus@gouv.mc
    • Principal Investigator: Eric VOIGLIO, MD, PhD
    • Sub-Investigator: Thomas ALTHAUS, MD, PhD
    • Sub-Investigator: Herve RAPS, MD
    • Sub-Investigator: Olivier DEJOUX, MD
    • Sub-Investigator: Patrick RAMPAL, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	48 Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Ct values in buccal and nasopharyngeal swabs	Ct values by PCR in buccal and nasopharyngeal swabs	48 Hours

Collaborators and Investigators

• Sponsor: Centre Scientifique de Monaco
• Collaborators: Department of Health Affairs, Monaco

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2021
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; POCT; RT-PCR; ELISA; Buccal; Contact case
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Severe Acute Respiratory Syndrome
• Other Study ID Numbers: PRO_CSM_01_2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No