Rapid Detection of COVID-19 by Portable and Connected Biosensor : Biological Proof of Concept

University Hospital, Lille200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

SARS-CoV Infection Covid19

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Sensitivity and specificity of CorDial-S based on the first nasopharyngeal swab taken on patient admission, compared to the final positive or negative diagnosis of COVID-19 by the medical team

Time frame: at patient admission (Baseline)

Secondary Outcomes

Cohen's Kappa Coefficient for concordance for the diagnosis of CoV-2-SARS between PCR and CorDial-S based on nasopharyngeal swabs taken at patient admission.

Time frame: at patient admission (Baseline)

Sensitivity and specificity of CorDial-S based on the first saliva sample taken at patient admission compared to the final positive or negative diagnosis of COVID-19 by the medical team.

Time frame: at patient admission (Baseline)

Cohen's Kappa Coefficient for concordance for the diagnosis of CoV-2-SARS between PCR and CorDial-S based on saliva samples taken at patient admission.

Time frame: at patient admission (Baseline)

Rapid Detection of COVID-19 by Portable and Connected Biosensor : Biological Proof of Concept

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes