Evaluation of the Feasibility and Analytic Performance of TestNPass (In Vitro Diagnosis Medical Device) for CoViD-19 Diagnosis on Saliva Sample. : a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Feasibility of TestNPass IVDMD for CoViD19 diagnosis on saliva samples.
Study Overview
Brief Summary
COVID19 pandemic and SARS-CoV-2 rapid progression worldwide are already historical landmarks of the 21st century owing to the magnitude of the event and the collective response that populations have adopted to face such threat. This menace has imposed an unprecedented reactivity to promptly deliver answers in various fields and specifically in termes of diagnostic capabilities.
The very first tests to be used were based on PCR reactions and on deep nasopharyngeal sampling. But this has shown to be insufficient to prevent contaminations and limit the progression of the disease. This approach requires important infrastructure thus limiting the extent to which it can be delivered. Moreover, nasopharyngeal swab is highly intrusive and therefore is not suitable for repeated testing of asymptomatic patients in surveillance programs.
Actual need is based on new tests offering new capabilities both in terms of wide range availability, ease of use and reduced time-to-result duration. Such tests, affordable and that can be performed outside the lab would ultimately relief pressure on healthcare workers and laboratory facilities as well as help test massively wide range of populations thus limiting viral dissemination
Such innovating test device has been developped by the start-up "Grapheal" and the present study will ultimately demonstrate the feasibility of COVID-19 diagnostic using this test.
Detailed Description
ACTUAL KNOWLEDGE ABOUT DIAGNOSTIC STRATEGIES Actual strategy for rapid and accurate diagnostic relies heavily (almost solely) on RT-PCR based tests. The French Scientific Board advising the national government in the management of this epidemic has brought back on September, 3rd the three-axis policy : " Test - Track - Isolate " as the central response to the COVID-19 progression. This strategy is also the response promoted by WHO since March. If properly applied, this approach allows high-performance in identifying positive cases and spotting transmission chains, thus allowing to specifically isolate and quarantine infectious patients. The expected outcome is a halting epidemic allowing economic recovery and protection of populations.
Rise in French laboratory capacities regarding their ability to perform the required tests has been achieved since the early days of COVID-19. Since August, 10th we have reached the pace of 100.000 daily tests nationwide and peaked above 300.000 tests per day as of October, 26th (Santé Publique France).
However, the need to lockdown the entire French population for a second time is the demonstration of the limits of this strategy. Issues can be summarized in a few key points:
- The hassle of performing as many tests as needed over the whole national territory has proven difficult and does not allow control of local epidemic bursts
- Repetitive sampling for asymptomatic patients to confirm viral clearance and lack of viral shedding raises strong questions regarding its feasibility
- The need for high quality sampling for RT-PCR tests accurately reaching nasopharyngeal cavity requires trained staff whose availability is limited. Swab collection remains an important bottleneck nationwide.
- Important consumption of PPE (personal protective equipment) for sampling staff adds an unnecessary tension in supply chains In the light of these issues, there is an urgent need to transition from RT-PCR tests to novel diagnostic techniques capable of addressing the above-mentioned key problems. Rapid Antigenic Tests are being evaluated and used already in some facilities and in very controlled settings. However, these tests do have important limitations and their relatively low sensibility in real-life setting (around 60% of positive agreement with RT-PCR for best-performing tests) is an issue that need to be quickly addressed to avoid jeopardizing efforts made to widespread tests and keep public confidence. Moreover, Rapid Antigenic Tests deliver results in 15 to 30 minutes' time, much faster than traditional RT-PCR, but still inadequate for massive population test in crowded places and public gathering (airports, shows and sporting events).
ABOUT MEDICAL DEVICE INVOLVED
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men or Women over 18 years old
- •suspect of COVID19 and consulting for a diagnosis at Grenoble University Hospital.
- •Duly informed and not opposed to participation at GraphealNPass' study
- •Affiliated to french social security.
Exclusion Criteria
- •Patients protected by law (minors, pregnant or breastfeeding woman, patient under guardianship or deprived of his/her liberty or hospitalized without his/her consent)
Outcomes
Primary Outcomes
Feasibility of TestNPass IVDMD for CoViD19 diagnosis on saliva samples.
Time Frame: DAY0 (single visit study, day of COVID19 diagnosis)
Electric signal obtained in TestNPass Graphene Biosensor for samples collected from known COVID19 positive patients.
Secondary Outcomes
- Analytics performance (sensibility) of TestNPass IVDMD(DAY0 (single visit study, day of COVID19 diagnosis))
- TestNPass IVDMD swiftness(DAY0 (single visit study, day of COVID19 diagnosis))
- Analytics performance (specificity) of TestNPass IVDMD(DAY0 (single visit study, day of COVID19 diagnosis))
- TestNPass IVDMD ease of use(DAY0 (single visit study, day of COVID19 diagnosis))
- Correlation of TestNPass electric signal intensity with RT-PCR Cycle threshold(DAY0 (single visit study, day of COVID19 diagnosis))