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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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SARS-CoV-2, COVID-19

Intervention / Treatment
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* Diagnostic Test: ELISA POCT vs RT-PCR


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Monocentric, Prospective, 3 components Nasopharyngeal swab by PCR Buccal swab by PCR Buccal by ELISA POCT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buccal and nasopharyngeal swabs<br>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<br>* 3 swabs taken, buccal for RT-PCR and ELISA POCT, nasopharyngeal for RT-PCR<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, POCT, RT-PCR, Contact case, ELISA, Buccal