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

• 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

Study Timeline

• Study Start: 2020-04-16
• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-29
• Primary Completion: 2020-05-17
• Study Completion: 2020-05-17
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-05

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France