COR-DIAL-S: Rapid Detection of COVID-19 by Portable and Connected Biosensor : Biological Proof of Concept
Study Details
Study Description
Brief Summary
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
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greater sensitivity
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a great speed because 8tests could be performed at the same time with a result in a few minutes
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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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Arms and Interventions
Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female or child without age limit
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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.
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Patient to be diagnosed by PCR test on nasopharyngeal swab.
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Social insured
Exclusion Criteria:
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Refusal of the person to participate (collection of information, second use of his sample, collection of saliva by spitting)
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Pregnant and breastfeeding women
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Protected Majors
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hopital Roger Salengro, CHU Lille | Lille | France | 59037 |
Sponsors and Collaborators
- University Hospital, Lille
Investigators
- Principal Investigator: Enagnon Kazali ALIDJINOU, MD, University Hospital, Lille
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021_0063
- 2021-A00387-34