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

NCT06917261 | Not Yet Recruiting

• 1 other identifier: 38RC24.0309
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

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 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.

Conditions

SARS-CoV-2 Infection

Keywords

SARS-CoV-2; Diagnosis; TestNPass; Nasopharyngeal Sample

Outcome Measures

Primary Outcomes (1)

• Analytics performance (specificity) of TestNPass

  Specificity in % of TestNPass using a nasopharyngeal swab. The specificity target is set at 99%.

  DAY0 (single visit study, day of COVID19 diagnosis)

Secondary Outcomes (1)

• Analytics performance (Sensitivity) of TestNPass

  DAY0 (single visit study, day of COVID19 diagnosis)

Study Arms (2)

Cases: 100 cases will be recruited : Patient diagnosed by RT-PCR for a COVID19

ACTIVE COMPARATOR

Diagnostic Test: TestNPass Patients will undergo nasopharyngeal sampling. Grenoble University Hospital lab will perform diagnosis using TestNPass IVDMD. Results won't be used for patient care (only recorded for RESEARCH purpose).

Diagnostic Test: nasopharyngeal swab.

Controls 300 controls : Patient suspected for a COVID-19 but negative by RT-PCR for a COVID19

SHAM COMPARATOR

Diagnostic Test: TestNPass Patients will undergo nasopharyngeal sampling. Grenoble University Hospital lab will perform diagnosis using TestNPass IVDMD. Results won't be used for patient care (only recorded for RESEARCH purpose).

Diagnostic Test: nasopharyngeal swab.

Interventions

nasopharyngeal swab. DIAGNOSTIC_TEST

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

Cases: 100 cases will be recruited : Patient diagnosed by RT-PCR for a COVID19; Controls 300 controls : Patient suspected for a COVID-19 but negative by RT-PCR for a COVID19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (2)

University Hospital of Grenoble, emergency department

Grenoble, 38700, France

Location

University Hospital of Grenoble, infectious disease department

Grenoble, 38700, France

Location

MeSH Terms

Conditions

COVID-19; Disease

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marion Le Maréchal

CONTACT

04 76 76 52 91; MLemarechal@chu-grenoble.fr

Saber TOUATI

CONTACT

04 76 76 58 05; stouati1@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: April 30, 2025
• Primary Completion: October 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

FR (2)