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

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 Overview

• Status: Completed
• Conditions: Covid19; SARS-CoV Infection
• Intervention / Treatment: Diagnostic test: COVID-19 RT-PCR; Diagnostic test: Biosensor

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Hopital Roger Salengro, CHU Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients admitted to a Reference Health Establishment for suspicion of SARS-CoV-2

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Positive diagnosis of SARS-CoV-2; 100 patients with a positive diagnosis of SARS-CoV-2	Diagnostic test: COVID-19 RT-PCR; Nasopharyngeal swabs for COVID-19 RT-PCR; Diagnostic test: Biosensor; Portable and Connected Biosensor viral
Negative diagnosis of SARS-CoV-2; 100 patients with a negative diagnosis of SARS-CoV-2 defined by the gold standard by the medical team	Diagnostic test: COVID-19 RT-PCR; Nasopharyngeal swabs for COVID-19 RT-PCR; Diagnostic test: Biosensor; Portable and Connected Biosensor viral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	at patient admission (Baseline)

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	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.	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.	at patient admission (Baseline)

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Enagnon Kazali ALIDJINOU, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2021
• Primary Completion (Actual): May 2, 2022
• Study Completion (Actual): May 2, 2022

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Severe Acute Respiratory Syndrome
• Other Study ID Numbers: 2021_0063; 2021-A00387-34 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No