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Development of a Molecular Diagnostic Strategy for SARS-CoV2 Based on Saliva in the Context of the COVID-19 Pandemic

Not Applicable
Completed
Conditions
COVID
RT-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
GroupInterventionDescription
Patient with COVID-19 infection suspicionSaliva collectionPatient with COVID-19 infection suspicion are tested using standard diagnosis method
Primary Outcome Measures
NameTimeMethod
Number of positive patient using saliva method compared to number of positive patient using standard methodOne hour
Number of negative patient using saliva method compared to number of negative patient using standard methodOne hour
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Rouen University Hospital

🇫🇷

Rouen, France

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