Development of a Molecular Diagnostic Strategy for SARS-CoV2 Based on Saliva in the Context of the COVID-19 Pandemic
Not Applicable
Completed
- Conditions
- COVIDRT-ddPCR Multiplex
- Interventions
- Diagnostic Test: Saliva collection
- Registration Number
- NCT04367545
- Lead Sponsor
- University Hospital, Rouen
- Brief Summary
The objective of the study is to develop and validate a molecular diagnostic strategy (RT-ddPCR multiplex) of COVID-19 based on a saliva sample and alternative to the RT-qPCR method, in order to :
1. to compensate for the risk of a shortage of diagnostic kits, reagents and materials necessary for molecular diagnosis;
2. to increase the molecular diagnostic capacity of COVID-19 at the Rouen University Hospital;
3. and to have a method compatible with screening extended to populations at risk.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
- Person aged over 18 years presenting to the COVID-19 consultation of the Rouen University Hospital for screening
- Person affiliated to a social security scheme
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Exclusion Criteria
- Person objecting to participation in the research after reading information
- Person under the protection of justice,
- Person deprived of their liberty by administrative or judicial decision (guardianship, curatorship, etc.)
- Patient under guardianship or curatorship
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patient with COVID-19 infection suspicion Saliva collection Patient with COVID-19 infection suspicion are tested using standard diagnosis method
- Primary Outcome Measures
Name Time Method Number of positive patient using saliva method compared to number of positive patient using standard method One hour Number of negative patient using saliva method compared to number of negative patient using standard method One hour
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rouen University Hospital
🇫🇷Rouen, France