Comparison of Detection of SARS-CoV2 (COVID-19) Between Nasopharyngeal Swab Specimens and Those Obtained by Salivary Sputum
- Conditions
- Covid19
- Interventions
- Diagnostic Test: Salivary test for COVID19
- Registration Number
- NCT05024461
- Lead Sponsor
- Centre Hospitalier de Cayenne
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1159
- Patient with an indication to perform a COVID diagnostic test (symptomatology, contact case, systematic screening etc...)
- Men and women at least 3 years old
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patient with an indication for a COVID19 test Salivary test for COVID19 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
- Primary Outcome Measures
Name Time Method Sensitivity of salivary test vs. nasopharyngeal test 1 day
- Secondary Outcome Measures
Name Time Method - 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) 1 day Positivity and negativity of the salivary test vs. symptomatology and associated terrain 1 day - Sensitivity of salivary test vs nasopharyngeal test with strong positives (3 genes detected) 1 day Description of the aspect of the saliva collected: mucous or fluid 1 day Description of the analytical criteria of the saliva sample
Perception of the tests by questionnaire (proportion of negative opinions) 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 weak positives (1 gene detected) 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)
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)
- Specificity of salivary test vs nasopharyngeal test with strong positives (3 genes detected) 1 day - Specificity of salivary test vs nasopharyngeal test with weak positives (1 gene detected) 1 day
Trial Locations
- Locations (1)
General Hospital of Cayenne
🇬🇫Cayenne, French Guiana