Clinical trial NCT05024461: Comparison of Detection of SARS-CoV2 (COVID-19) Between Nasopharyngeal Swab Specimens and Those Obtained by Salivary Sputum
Official title: Comparison of the Results, Feasibility and Acceptability of Molecular Detection of SARS-CoV2 Between Nasopharyngeal Swab Specimens Recovered in Virological Transport Medium and Those Obtained by Salivary Sputum
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 1159
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of salivary test vs. nasopharyngeal test
timeFrame: 1 day
Secondary outcomes:
measure: - 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
timeFrame: 1 day
measure: Perception of the tests by questionnaire (proportion of positive opinions)
timeFrame: 1 day
measure: Perception of the tests by questionnaire (proportion of negative opinions)
timeFrame: 1 day
measure: Positivity and negativity of the salivary test vs. symptomatology and associated terrain
timeFrame: 1 day
measure: Sensitivity and specificity analysis between the salivary test and the nasopharyngeal test according to the clinical context
timeFrame: 1 day
measure: Description of the aspect of the saliva collected: mucous or fluid
timeFrame: 1 day
measure: Volume of saliva collected (mL)
timeFrame: 1 day
measure: Description of the analytical criteria of the saliva sample:pre-analytical treatments if necessary
timeFrame: 1 day
measure: Number of Cycle threeshold for the first analysis (done at the Cayenne hospital) and the second analysis (done at the university hospital of Caen)
timeFrame: 1 day
measure: - Sensitivity of salivary test vs nasopharyngeal test with strong positives (3 genes detected)
timeFrame: 1 day
measure: - Specificity of salivary test vs nasopharyngeal test with strong positives (3 genes detected)
timeFrame: 1 day
measure: - Sensitivity of salivary test vs nasopharyngeal test with weak positives (1 gene detected)
timeFrame: 1 day
measure: - Specificity of salivary test vs nasopharyngeal test with weak positives (1 gene detected)
timeFrame: 1 day
Other outcomes:
Locations:
city: Cayenne
country: French Guiana
facility: General Hospital of Cayenne
Study officials:
References: