The main objective is to expand screening for severe acute respiratory syndromecoronavirus 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-19ANTIGEN 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.
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Diagnostic Test: ELISA POCT vs RT-PCR
3 swabs taken, buccal for RT-PCR and ELISA POCT, nasopharyngeal for RT-PCR
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.
Centre National de Depistage - Espace Leo Ferre
Monaco, Monaco
Investigator: Eric VOIGLIO, MD, PhD
Contact: +37798984850
evoiglio@gouv.mc
Eric VOIGLIO, MD, PhD
+37798984850
evoiglio@gouv.mc
Not Provided