Rapid Detection of COVID-19 by Portable and Connected Biosensor : Biological Proof of Concept (COR-DIAL-S)

University Hospital, Lille

Status: Completed

Conditions: SARS-CoV Infection; Covid19

Treatments: Diagnostic Test: COVID-19 RT-PCR; Diagnostic Test: Biosensor

Study type: Observational

Funder types: Other

Identifiers

NCT04780334

2021_0063

2021-A00387-34 (Other Identifier)

Details and patient eligibility

About

The main objective of this CorDial-S proof-of-concept study is to evaluate the ability to detect COVID-19 infection in nasopharyngeal swabs with CorDial-S and compare it to the PCR technique currently in use. Saliva analysis will be the subject of secondary analysis.

The CorDial-S medical device could allow the specimens to be analyzed using a small portable device and the results to be returned in minutes to the medical team and the patient, and communicated in real time with a telemedicine and remote monitoring system to the health authorities to allow the necessary protective, containment and therapeutic management measures to be put in place if necessary.

The benefits would be

1. greater sensitivity
2. a great speed because 8tests could be performed at the same time with a result in a few minutes
3. a very high specificity at least equivalent to PCR.

This new diagnostic strategy could become extremely valuable in the fight against COVID-19, especially in the case of very long-term persistence and incomplete vaccination of the French and foreign population.

Enrollment: 200 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female or child without age limit
• Admitted to a Reference Health Establishment (RHS) in an emergency unit, hospitalization or intensive care unit for suspicion of SARS-CoV-2 infection regardless of clinical presentation and degree of severity.
• Patient to be diagnosed by PCR test on nasopharyngeal swab.
• Social insured

Exclusion criteria

• Refusal of the person to participate (collection of information, second use of his sample, collection of saliva by spitting)
• Pregnant and breastfeeding women
• Protected Majors

Trial design

200 participants in 2 patient groups

Positive diagnosis of SARS-CoV-2

Description:

100 patients with a positive diagnosis of SARS-CoV-2

Treatment:

Diagnostic Test: Biosensor

Diagnostic Test: COVID-19 RT-PCR

Negative diagnosis of SARS-CoV-2

Description:

100 patients with a negative diagnosis of SARS-CoV-2 defined by the gold standard by the medical team

Treatment:

Diagnostic Test: Biosensor

Diagnostic Test: COVID-19 RT-PCR