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

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

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2 Infection
• Intervention / Treatment: Diagnostic test: nasopharyngeal swab.

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 elicited from medical teams, governments, and the general public. This situation requires a rapid and effective response to identify solutions, particularly in the field of diagnostics.

While the initial tests used were based on PCR (polymerase chain reaction) and deep nasopharyngeal swabs, this approach has shown limitations in controlling the epidemic. The significant logistical resources required for implementation limit its large-scale use beyond current applications. In addition, deep nasopharyngeal sampling is not feasible for repeated testing of healthy populations as part of primary screening.

The current need is the development of new point-of-care (PoC) testing methods that are rapid, affordable, and easy to use. These characteristics would enable mass deployment in outpatient settings, reducing the burden on healthcare teams. Furthermore, a test that is easy to produce and can be stored at room temperature would address the immense logistical challenge of regularly testing the general population to specifically isolate virus carriers.

In this context, an innovative test called TestNPass has been developed by the Grenoble-based start-up company Grapheal. TestNPass is a rapid and low-cost antigen test for screening and diagnosis that delivers a secure digital passport and/or QR code upon request. This type of device may also be used to detect various antigens, such as those of influenza, streptococcus A, or shingles.

The objective of this study is to evaluate the diagnostic performance of an in vitro diagnostic medical device (IVD) for the detection of SARS-CoV-2 infection using a nasopharyngeal swab. To achieve this, an additional nasopharyngeal swab sample will be collected immediately after the sample taken as part of routine healthcare procedures.

A total of 400 adult participants who require a nasopharyngeal swab for medical care will be enrolled in the study. The only additional procedure involved is the collection of a second nasopharyngeal swab. The study consists of a single visit (1 day).

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38700
    • University Hospital of Grenoble, emergency department
  • Grenoble, France, 38700
    • University Hospital of Grenoble, infectious disease department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cases: 100 cases will be recruited : Patient diagnosed by RT-PCR for a COVID19; 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.; The only additional procedure related to the study is a nasopharyngeal swab.
Sham Comparator: Controls 300 controls : Patient suspected for a COVID-19 but negative by RT-PCR for a COVID19; 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.; The only additional procedure related to the study is a nasopharyngeal swab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analytics performance (specificity) of TestNPass	Specificity in % of TestNPass using a nasopharyngeal swab. The specificity target is set at 99%.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analytics performance (Sensitivity) of TestNPass	Sensitivity in %, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR), and negative likelihood ratio (NLR).	Baseline

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Actual): February 28, 2026
• Study Completion (Actual): February 28, 2026

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Diagnosis; TestNPass; Nasopharyngeal Sample
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Pathological Conditions, Signs and Symptoms; COVID-19; Disease
• Other Study ID Numbers: 38RC24.0309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No