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Sponsor: University Hospital, Grenoble
Conditions: SARS-CoV-2 Infection
Interventions: nasopharyngeal swab.
Countries: France
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 chain reaction) performed through a deep nasopharyngeal swab, have shown limitations in controlling the epidemic. The current need is to develop new tests that are rapid, affordable, and easy to use, and that can be implemented on a large scale in outpatient settings to reduce the burden on healthcare teams. In addition, a test that is easy to produce and can be stored at room temperature would help overcome the significant logistical challenge of regularly testing the general population to specifically isolate carriers of the virus. In this context, an innovative test called TestNPass has been developed. TestNPass is a rapid and affordable antigen test for screening and diagnosis that provides a secure digital passport and/or QR code upon request. The objective of this study is to evaluate the diagnostic performance of TestNPass using nasopharyngeal swabs for the detection of SARS-CoV-2 infection.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * 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 Criteria: * 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
- Grenoble, France
- Grenoble, France