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

NCT06917261 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-05-12

No results posted yet for this study

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 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.

Conditions

Interventions

DIAGNOSTIC_TEST

nasopharyngeal swab.

The only additional procedure related to the study is a nasopharyngeal swab.

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06917261 on ClinicalTrials.gov