Respiratory Tract Infections
Conditions
Keywords
SARS-CoV-2, saliva, diagnostic
Brief summary
Constitution of a collection of SARS-CoV-2 RNA extracts from nasopharyngeal and saliva / sputum samples, from the same patients (paired samples), taken during the same consultation in an indication of detection of SARS-CoV-2 in with a view to developing tests / diagnostic tools for SARS-CoV-2.
Detailed description
In order to preserve their anonymity, the participant will be identified in a dedicated form by a unique identification number. An identification list of participants will be kept in the investigator's file. The investigator will ensure that the anonymity of each person participating in the research is guaranteed. The source documents are the original documents, data and files from which the data concerning the participant is reported in the Data set\_COLL001.xls form provided to the investigator which will serve as an observation notebook. The investigator must agree to allow direct access to research source data during monitoring, audit or inspection visits. The source data is for the most part computerized and accessible after authorization. The data will be transcribed into an Excel form Data set\_COLL001.xls pseudonymized form which will serve as an observation book. The data will be recorded and then transmitted to ID SOLUTIONS via the Data set\_COLL001.xls form provided to the investigator.
Interventions
OTHERsaliva sampling
when the patient goes to the laboratory for a covid 19 diagnostic from a routine nasopharingeal sample, an additionnal sample of saliva is asked
Sponsors
ID Solutions
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male, female adult * Patient with an indication for SARS-CoV-2 screening. * Patient having been informed and having given his non-objection to participate in the study * Patient affiliated with a French social security scheme or beneficiary of such a scheme
Exclusion criteria
* Pregnant or breastfeeding women * Vulnerable people Adults placed under tutorship or curatorship or under judicial protection, Patient unable to personally give consent, or adult protected by law, Opposition expressed to inclusion in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| collection of RNA extracted nasopharyngeal and saliva samples | up to 1 month over which the samples of each participant are collected then tested | n=130 positive n=130 negative RNA extracted from both nasopharyngeal and saliva samples from same patients sampled at the same time with suspicious COVID-19 will |
Countries
France
Outcome results
None listed