The COVID-19 pandemic has created a major global health crisis that requires a rapid andeffective response, particularly in the field of diagnostics.The first tests used, based on PCR (polymerase chain reaction) performed through a deepnasopharyngeal swab, have shown their limitations in controlling the epidemic. Thecurrent need is to develop new tests that are rapid, affordable and easy to use, and thatcan be used on a large scale in outpatient settings to reduce the burden on healthcareteams. In addition, a test that is easy to produce and can be stored at room temperaturewould help overcome the significant logistical challenge of regularly testing the generalpopulation to specifically isolate carriers of the virus.In this context, an innovative test called "TestNPass" has been developed. TestNPass is arapid and affordable antigen test for screening and diagnosis that provides a securedigital passport and/or QR code upon request.Our aim is to evaluate the diagnostic performance of TestNPass using nasopharyngeal swabsfor the detection of SARS-CoV-2 infection.
The COVID-19 pandemic and the global spread of SARS-CoV-2 are historic events in terms of
their magnitude and the collective response they have elicited from medical teams,
governments and the general public. This situation requires a rapid and effective
response to find 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 its limitations in controlling the
epidemic. The significant logistical resources required for its implementation limit its
large-scale use beyond what is currently being done. In addition, deep nasopharyngeal
sampling is not feasible for repeated testing of healthy populations as part of primary
screening.
The current need is to develop new point-of-care (PoC) testing methods that are rapid,
affordable and easy to use. These characteristics would allow mass use in outpatient
settings, reducing the burden on healthcare teams. In addition, 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 on
request. This type of device could also be used to detect various antigens, such as those
of influenza, streptococcus A or shingles.
Our objective in 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, we will take an additional nasopharyngeal swab
sample immediately after the sample taken as part of routine health care.
A total of 400 adult participants who require a nasopharyngeal swab for their medical
care will be enrolled in this study. The only additional procedure involved in the study
is the collection of a second nasopharyngeal swab. The study consists of a single visit
(1 day).
Diagnostic Test: nasopharyngeal swab.
The only additional procedure related to the study is a nasopharyngeal swab.
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
University Hospital of Grenoble, emergency department
Grenoble, France
University Hospital of Grenoble, infectious disease department
Grenoble, France
Marion Le Maréchal
04 76 76 52 91
MLemarechal@chu-grenoble.fr
Saber TOUATI
04 76 76 58 05
stouati1@chu-grenoble.fr
Not Provided