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Multicenter observational study of diagnostic test validation (Research Involving the Human Person, type 3) In addition to the diagnosis by the reference method (nasopharyngeal swab), the patient will be asked to provide a saliva sample via a salivary spit. The clinical circumstances of the diagnosis, the age of the patient, the associated terrain (diabetes, immunodepression, pregnancy) will be noted. The nasopharyngeal and saliva samples will be analyzed in Cayenne and the remaining samples will be frozen and stored at the CRB before being sent to the University Hospital of Caen for analysis and concordance verification.
The expected benefits are:
Possibility of repeating tests in the same person more easily due to the absence of pain and thus reduce the barriers to diagnosis and screening.
Possibility of self-sampling, which could simply be sent to the laboratory, which would relieve the diagnostic sites that mobilize staff and require a fairly heavy organization. Avoid long waiting lines that can be an obstacle and lead to a renunciation of the diagnosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with an indication for a COVID19 test | Experimental | The persons included will be those who have an indication for a COVID 19 test and who present themselves at the Cayenne hospital and during the screening missions organised by the Red Cross and Médecin du Monde during the COVID 19 epidemic in the territory |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salivary test for COVID19 | Diagnostic Test | Results of nasopharyngeal and salivary samples taken at the Cayenne hospital and the Caen university center,
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of salivary test vs. nasopharyngeal test | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| - Proportion of analyses not performed on salivary samples for the following reasons (vs. number of salivary sample analyses performed): o Insufficient quantity of biological sample, o Inability to collect the sample | 1 day | |
| Perception of the tests by questionnaire (proportion of positive opinions) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Cayenne | Cayenne | 97306 | French Guiana |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
| 1 day |
| Perception of the tests by questionnaire (proportion of negative opinions) | 1 day |
| Positivity and negativity of the salivary test vs. symptomatology and associated terrain | 1 day |
| Sensitivity and specificity analysis between the salivary test and the nasopharyngeal test according to the clinical context | Sensitivity and specificity analysis between the salivary test and the nasopharyngeal test according to the time between the samples and the onset of symptoms, the time between the samples and the contact with an index case, the known immunodepression and the clinical context (diabetes, pregnancy) | 1 day |
| Description of the aspect of the saliva collected: mucous or fluid | Description of the analytical criteria of the saliva sample | 1 day |
| Volume of saliva collected (mL) | Description of the analytical criteria of the saliva sample: (pipette measurement, if the saliva is not fluid, pipette measurement after vortexing for 1 min) | 1 day |
| Description of the analytical criteria of the saliva sample:pre-analytical treatments if necessary | 1 day |
| Number of Cycle threeshold for the first analysis (done at the Cayenne hospital) and the second analysis (done at the university hospital of Caen) | 1 day |
| - Sensitivity of salivary test vs nasopharyngeal test with strong positives (3 genes detected) | 1 day |
| - Specificity of salivary test vs nasopharyngeal test with strong positives (3 genes detected) | 1 day |
| - Sensitivity of salivary test vs nasopharyngeal test with weak positives (1 gene detected) | 1 day |
| - Specificity of salivary test vs nasopharyngeal test with weak positives (1 gene detected) | 1 day |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |