Clinical Research Directory

Evaluation of the Diagnostic Performance of the TestNPass DM-DIV for SARS-CoV-2 Using a Nasopharyngeal Sample

Sponsor: University Hospital, Grenoble

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 chain reaction) performed through a deep nasopharyngeal swab, have shown their 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 used 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. Our aim is to evaluate the diagnostic performance of TestNPass using nasopharyngeal swabs for the detection of SARS-CoV-2 infection.

Official title: Evaluation of the Diagnostic Performance of the DM-DIV (in Vitro Diagnostic Medical Device) TestNPass for the Diagnosis of SARS-CoV-2 Infection Using a Nasopharyngeal Sample

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