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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RNA extracted from Positive NSP samples | RNA extracted from NSP samples, found positive for the presence of SARS-CoV-2 | ||
| RNA extracted from Positive saliva samples | RNA extracted from saliva samples found positive for the presence of SARS-CoV-2 |
| |
| RNA extracted from negative NSP samples | RNA extracted from NSP samples, found negative for the presence of SARS-CoV-2 | ||
| RNA extracted from negative saliva samples | RNA extracted from saliva samples found negative for the presence of SARS-CoV-2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| saliva sampling | Other | when the patient goes to the laboratory for a covid 19 diagnostic from a routine nasopharingeal sample, an additionnal sample of saliva is asked |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with an indication for SARS-CoV-2 screening
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy M Bayette, Dr | Labosud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bioaxiome | Nîmes | 30900 | France |
the data will not be shared to other researchers since the research is an internal collection of samples; for ID SOLUTIONS
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D004194 | Disease |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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RNA extracted from nasopharyngeal and saliva / sputum extracts from the same patients