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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00387-34 | Other Identifier | ID-RCB number, ANSM |
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The main objective of this CorDial-S proof-of-concept study is to evaluate the ability to detect COVID-19 infection in nasopharyngeal swabs with CorDial-S and compare it to the PCR technique currently in use. Saliva analysis will be the subject of secondary analysis.
The CorDial-S medical device could allow the specimens to be analyzed using a small portable device and the results to be returned in minutes to the medical team and the patient, and communicated in real time with a telemedicine and remote monitoring system to the health authorities to allow the necessary protective, containment and therapeutic management measures to be put in place if necessary.
The benefits would be
This new diagnostic strategy could become extremely valuable in the fight against COVID-19, especially in the case of very long-term persistence and incomplete vaccination of the French and foreign population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive diagnosis of SARS-CoV-2 | 100 patients with a positive diagnosis of SARS-CoV-2 |
| |
| Negative diagnosis of SARS-CoV-2 | 100 patients with a negative diagnosis of SARS-CoV-2 defined by the gold standard by the medical team |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 RT-PCR | Diagnostic Test | Nasopharyngeal swabs for COVID-19 RT-PCR |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of CorDial-S based on the first nasopharyngeal swab taken on patient admission, compared to the final positive or negative diagnosis of COVID-19 by the medical team | at patient admission (Baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Cohen's Kappa Coefficient for concordance for the diagnosis of CoV-2-SARS between PCR and CorDial-S based on nasopharyngeal swabs taken at patient admission. | at patient admission (Baseline) | |
| Sensitivity and specificity of CorDial-S based on the first saliva sample taken at patient admission compared to the final positive or negative diagnosis of COVID-19 by the medical team. |
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Inclusion Criteria:
Exclusion Criteria:
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patients admitted to a Reference Health Establishment for suspicion of SARS-CoV-2
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| Name | Affiliation | Role |
|---|---|---|
| Enagnon Kazali ALIDJINOU, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Roger Salengro, CHU Lille | Lille | 59037 | France |
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| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
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| ID | Term |
|---|---|
| D000087123 | COVID-19 Nucleic Acid Testing |
| ID | Term |
|---|---|
| D000086742 | COVID-19 Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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nasopharyngeal swab and saliva
| Biosensor | Diagnostic Test | Portable and Connected Biosensor viral |
|
| at patient admission (Baseline) |
| Cohen's Kappa Coefficient for concordance for the diagnosis of CoV-2-SARS between PCR and CorDial-S based on saliva samples taken at patient admission. | at patient admission (Baseline) |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| D008919 | Investigative Techniques |