SARS-CoV-2 InfectionTESTOGRAPHNCT06917261
Evaluation of the Diagnostic Performance of the TestNPass DM-DIV for SARS-CoV-2 Using a Nasopharyngeal Sample
A study testing nasopharyngeal swab. in people with SARS-CoV-2 Infection, run by University Hospital, Grenoble at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- nasopharyngeal swab.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Apr 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital of Grenoble, emergency department
Grenoble, 38700
University Hospital of Grenoble, infectious disease department
Grenoble, 38700
About this study
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
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.
Read more
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.
Read the 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).
- Conditions
- SARS-CoV-2 Infection
- Being tested
- nasopharyngeal swab.
- Keywords
- SARS-CoV-2, Diagnosis, TestNPass, Nasopharyngeal Sample
- Medical subject headings
- COVID-19, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasopharyngeal swab.Diagnostic test
The only additional procedure related to the study is a nasopharyngeal swab.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Diagnostic Test: nasopharyngeal swab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analytics performance (specificity) of TestNPass
Specificity in % of TestNPass using a nasopharyngeal swab. The specificity target is set at 99%.
Measured: Baseline
Secondary outcomes (1)
Analytics performance (Sensitivity) of TestNPass
Sensitivity in %, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR), and negative likelihood ratio (NLR).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start30 Apr 2025
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917261
- Sponsor's protocol ID
- 38RC24.0309
- Acronym
- TESTOGRAPH
- Status last verified
- May 2026
- First submitted
- 1 Apr 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06917261
- Acronym / sponsor ID
- TESTOGRAPH / 38RC24.0309
- Conditions
- SARS-CoV-2 Infection
- Keywords
- SARS-CoV-2, Diagnosis, TestNPass, Nasopharyngeal Sample
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases: 100 cases will be recruited : Patient diagnosed by RT-PCR for a COVID19 | Active comparator | Diagnostic Test: nasopharyngeal swab.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). |
| Controls 300 controls : Patient suspected for a COVID-19 but negative by RT-PCR for a COVID19 | Sham comparator | Diagnostic Test: nasopharyngeal swab.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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasopharyngeal swab.The only additional procedure related to the study is a nasopharyngeal swab. | Diagnostic test | 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 |
Primary outcome
Analytics performance (specificity) of TestNPass
Time frame: Baseline
Specificity in % of TestNPass using a nasopharyngeal swab. The specificity target is set at 99%.
1 secondary outcome
Analytics performance (Sensitivity) of TestNPass
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasopharyngeal swab. in people with SARS-CoV-2 Infection, run by University Hospital, Grenoble at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analytics performance (specificity) of TestNPass (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.