Status:
NOT_YET_RECRUITING
Evaluation of the Diagnostic Performance of the TestNPass DM-DIV for SARS-CoV-2 Using a Nasopharyngeal Sample
Lead Sponsor:
University Hospital, Grenoble
Conditions:
SARS-CoV-2 Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The COVID-19 pandemic has created a major global health crisis that requires a rapid and effective response, particularly in the field of diagnostics. The first tests used, based on PCR (polymerase c...
Detailed Description
The COVID-19 pandemic and the global spread of SARS-CoV-2 are historic events in terms of their magnitude and the collective response they have elicited from medical teams, governments and the general...
Eligibility Criteria
Inclusion
- Adults ≥18 years of age
- Consulting or hospitalized at the University Hospital of Grenoble Alpes, for whom a SARS-CoV-2 RT-PCR test via nasal swab is considered due to symptoms or context (hospitalization in a double room, ongoing epidemic outbreak)
- Having provided informed consent to participate in the study.
- Patient having the rights to French social insurance
Exclusion
- Contraindication to nasopharyngeal swabbing:
- Anatomical abnormalities or medical conditions:
- Severe nasal septum deviation or nasal polyps
- History of recent nasal or facial surgery
- Severe sinusitis or nasal infections
- Bleeding disorders
- Extreme sensitivity or phobias related to medical procedures
- Participation in an exclusion period of another SARS-CoV-2 performance study: Minors
- Pregnant or breastfeeding women, Individuals under guardianship or curatorship, Individuals deprived of liberty or involuntarily hospitalized, Individuals under administrative or judicial supervision, Persons unable to provide informed consent
- Staff with a hierarchical relationship with the principal investigator
Key Trial Info
Start Date :
April 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06917261
Start Date
April 30 2025
End Date
December 30 2025
Last Update
April 8 2025
Active Locations (2)
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1
University Hospital of Grenoble, emergency department
Grenoble, France, 38700
2
University Hospital of Grenoble, infectious disease department
Grenoble, France, 38700