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

University Hospital, Rouen

Status: Completed

Conditions: COVID; RT-ddPCR Multiplex

Treatments: Diagnostic Test: Saliva collection

Study type: Interventional

Funder types: Other

Identifiers

NCT04367545

2020/0094/OB

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

Patient with COVID-19 infection suspicion

Experimental group

Description:

Patient with COVID-19 infection suspicion are tested using standard diagnosis method

Treatment:

Diagnostic Test: Saliva collection