Covid19
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTSalivary test for COVID19
Results of nasopharyngeal and salivary samples taken at the Cayenne hospital and the Caen university center, * Pre-analytical particularities and analytical particularities * Cycle threeshold * Demographic variables * Clinical variables * Clinical criteria * Questionnaire on the perception of the 2 sampling methods
Sponsors
Centre Hospitalier de Cayenne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patient with an indication to perform a COVID diagnostic test (symptomatology, contact case, systematic screening etc...) * Men and women at least 3 years old
Exclusion criteria
* Refusal of the patient or his legal representative, * Taking treatments that reduce salivary volume (anticholinergic activity) * Impossibility to perform the nasopharyngeal test * Patient under guardianship or curatorship, persons placed under protective measures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of salivary test vs. nasopharyngeal test | 1 day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perception of the tests by questionnaire (proportion of positive opinions) | 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 | 1 day | 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) |
| Description of the aspect of the saliva collected: mucous or fluid | 1 day | Description of the analytical criteria of the saliva sample |
| Volume of saliva collected (mL) | 1 day | Description of the analytical criteria of the saliva sample: (pipette measurement, if the saliva is not fluid, pipette measurement after vortexing for 1 min) |
| - 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 | — |
| 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 | — |
| Description of the analytical criteria of the saliva sample:pre-analytical treatments if necessary | 1 day | — |
Countries
French Guiana
Outcome results
None listed