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Rapid Detection of COVID-19 by Portable and Connected Biosensor

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04367142
Acronym
COR-DIAL-1
Enrollment
200
Registered
2020-04-29
Start date
2020-08-24
Completion date
2023-05-02
Last updated
2024-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sars-CoV2

Brief summary

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.

Interventions

DIAGNOSTIC_TESTCOVID-19 RT-PCR

Nasopharyngeal swabs for COVID-19 RT-PCR

DIAGNOSTIC_TESTBiosensor

Portable and Connected Biosensor viral

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of the COR-DIAL based on nasopharyngeal swabs taken on admission of the patient compared to the final diagnosis of COVID-19 made by the medical teamBaseline (at admission)

Secondary

MeasureTime frame
Cohen's Kappa Coefficient for concordance for the diagnosis of CoV-2-SARS between PCR and COR-DIAL based on nasopharyngeal swabs taken on patient admissionBaseline (at admission)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026