CORDAGES: SARS-CoV-2 Buccal Screening Evaluation Using an RT-PCR Assay and a Rapid ELISA Test Among Symptomatic and Asymptomatic Patients
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.
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.
Arms and Interventions
|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
Primary Outcome Measures
- 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
- Comparison of Ct values in buccal and nasopharyngeal swabs [48 Hrs]
Ct values by PCR in buccal and nasopharyngeal swabs
18+ patient eligible for COVID-19 testing in Monaco
symptoms suggestive of COVID-19
contact with a confirmed case of COVID-19
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
|1||Centre National de Depistage - Espace Leo Ferre||Monaco||Monaco||98000|
Sponsors and Collaborators
- Centre Scientifique de Monaco
- Department of Health Affairs, Monaco
Study Documents (Full-Text)None provided.