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Sampling salivaryWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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Name (Synonyms) Correlation

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 Evaluation of Quickly Diagnostic Saliva Tests for SARS-CoV-2

Coronavirus disease 2019 or COVID-19 is a highly contagious infectious disease. Symptoms of the disease are non-specific (fever, cough, dyspnea and fatigue), common with many seasonal viruses, which complicates the diagnosis. For mild forms, which represent the vast majority of cases, hospitalization is not necessary and treatment is symptomatic. However in more severe cases, hospitalization is required and sometimes even admission to an intensive care unit. Several diagnostic tests are already available, but they require, in all cases, the intervention of qualified health personnel to carry out the sample, which includes a risk of contagion and an expensive and time-consuming laboratory analysis and reagents. These tests are therefore not very suitable for massive screenings. We want to evaluate the performance of a detection test performed on a salivary sample in the diagnosis of SARS-CoV-2. This test will be non-invasive, performed without any analytical device and will restore its qualitative result "infected versus non-infected" in less than 1 hour (30min objective).

NCT04337424 SARS-CoV-2 Diagnostic Test: Sampling salivary

Primary Outcomes

Description: Detection by the LAMP method is to be corroborated with the reference method, RT-PCR on the same salivary sample. Only one sample is taken per subject participating in the study. The sample is divided into two aliquots which will be analyzed by LAMP and RT-PCR

Measure: Specific detection of SARS-CoV-2 specific RNA

Time: 1 day

Secondary Outcomes

Description: This test developed by SYS2DIAG / SKILLCELL must be able to detect a minimum viral load equivalent to that of the standard method on the same salivary sample.

Measure: Analytical sensitivity of the LAMP test.

Time: 1 day

Description: A correlation between the viral loads measured on the same sample by RT-PCR and by LAMP will be carried out.

Measure: The correlation between the measurement of the assayed viral load (CT value) by the standard method and by the LAMP developed by SYS2DIAG / SKILLCELL.

Time: 1 day

Description: The RT-PCR results on these 2 types of samples and the LAMP results for the saliva samples will be compared with the patient diagnosis to assess the feasibility and performance of the saliva samples for the molecular diagnosis of SARS-CoV-2.

Measure: Evaluation of the use of saliva samples compared to nasopharyngeal samples

Time: 1 day


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