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| Name | Class |
|---|---|
| Department of Health Affairs, Monaco | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buccal and nasopharyngeal swabs | Experimental | One patient will have 3 swabs taken, 2 buccal for PCR and ELISA POCT, 1 nasopharyngeal for PCR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELISA POCT vs RT-PCR | Diagnostic Test | 3 swabs taken, buccal for RT-PCR and ELISA POCT, nasopharyngeal for RT-PCR |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Ct values in buccal and nasopharyngeal swabs | Ct values by PCR in buccal and nasopharyngeal swabs | 48 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric VOIGLIO, MD, PhD | Contact | +37798984850 | evoiglio@gouv.mc |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre National de Depistage - Espace Leo Ferre | Recruiting | Monaco | 98000 | Monaco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40399889 | Derived | Althaus T, Blake A, Costantini A, Lavagna C, Jacquesson E, Groshenry G, Troel A, Vanzo B, Dejoux O, Raps H, Rampal P, Voiglio EJ. Diagnostic accuracy of non-invasive SARS-CoV-2 screening tests: a national prospective analysis. BMC Infect Dis. 2025 May 21;25(1):727. doi: 10.1186/s12879-025-11088-x. |
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Monocentric, Prospective, 3 components Nasopharyngeal swab by PCR Buccal swab by PCR Buccal by ELISA POCT
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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