Rapid Detection of COVID-19 by Portable and Connected Biosensor (COR-DIAL-1)

University Hospital, Lille

Status: Completed

Conditions: Sars-CoV2

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

Study type: Observational

Funder types: Other

Identifiers

NCT04367142

2020_36

2020-A01147-32 (Other Identifier)

Details and patient eligibility

About

The objective of study is to estimate the sensitivity and specificity of the COR-DIAL based on nasopharyngeal samples taken at the patient's admission in relation to the final diagnosis of COVID-19 made by the medical team.

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 in an emergency unit, hospitalisation or intensive care unit for suspicion of SARS-CoV-2 infection, regardless of the clinical presentation and degree of severity.
• Patient to be diagnosed using a PCR test on nasopharyngeal swab.
• Social insured

Exclusion criteria

• Atypical or suspicious cases without a final diagnosis of COVID-19 positive or negative
• Patient refusal to participate

Trial design

200 participants in 2 patient groups

positive SARS-Cov2

Description:

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

Treatment:

Diagnostic Test: Biosensor

Diagnostic Test: COVID-19 RT-PCR

negative SARS-Cov2

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