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

COVID-19 Clinical Trial

— CORDAGES  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05074745
• Other study ID #: PRO_CSM_01_2021
• Status: Recruiting
• Phase: N/A
• Start date: February 18, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: October 2021
• Source: Centre Scientifique de Monaco
• Contact: Eric VOIGLIO, MD, PhD
• Phone: +37798984850
• Email: evoiglio[@]gouv.mc
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2
• Severe Acute Respiratory Syndrome

Intervention

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

Locations

Country	Name	City	State
Monaco	Centre National de Depistage - Espace Leo Ferre	Monaco

Sponsors (2)

Lead Sponsor	Collaborator
Centre Scientifique de Monaco	Department of Health Affairs, Monaco

Country where clinical trial is conducted

Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of Ct values in buccal and nasopharyngeal swabs	Ct values by PCR in buccal and nasopharyngeal swabs	48 Hours