Collection of RNA Extracted From Nasopharyngeal and Saliva Samples From Same Patients With Suspicion of Covid-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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Collection of SARS-CoV-2 RNA Extracted From Nasopharyngeal and Saliva Samples From Same Patients

Conditions
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Respiratory Tract Infections

Intervention / Treatment
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* Other: saliva sampling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RNA extracted from Positive NSP samples<br>RNA extracted from NSP samples, found positive for the presence of SARS-CoV-2 | |
| RNA extracted from Positive saliva samples<br>RNA extracted from saliva samples found positive for the presence of SARS-CoV-2 | Other: saliva sampling<br>* when the patient goes to the laboratory for a covid 19 diagnostic from a routine nasopharingeal sample, an additionnal sample of saliva is asked<br>|
| RNA extracted from negative NSP samples<br>RNA extracted from NSP samples, found negative for the presence of SARS-CoV-2 | |
| RNA extracted from negative saliva samples<br>RNA extracted from saliva samples found negative for the presence of SARS-CoV-2 | Other: saliva sampling<br>* when the patient goes to the laboratory for a covid 19 diagnostic from a routine nasopharingeal sample, an additionnal sample of saliva is asked<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| collection of RNA extracted nasopharyngeal and saliva samples | 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 | up to 1 month over which the samples of each participant are collected then tested | 
| collection of RNA extracted nasopharyngeal and saliva samples | Collection of 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 enter the collection | up to 1 month over which the samples of each participant are collected then tested | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, saliva, diagnostic