NCT04780334

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 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.

Conditions

• SARS-CoV Infection
• Covid19

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	COVID-19 RT-PCR	Nasopharyngeal swabs for COVID-19 RT-PCR
DIAGNOSTIC_TEST	Biosensor	Portable and Connected Biosensor viral

Timeline

• Start date: 2021-07-07
• Primary completion: 2022-05-02
• Completion: 2022-05-02
• First posted: 2021-03-03
• Last updated: 2024-12-13

Locations

1 site across 1 country: France