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Last Updated: 11 October 2021

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Evaluation of the Feasibility and Analytic Performance of TestNPass (In Vitro Diagnosis Medical Device) for CoViD-19 Diagnosis on Saliva Sample. : a Pilot Study

The French Scientific Board advising the national government in the monitoring of this epidemic has brought back on September, 3rd the three-axis policy:" Test - Track - Isolate" as the central response to the COVID-19 development. ABOUT MEDICAL DEVICE INVOLVED \ n \ nVincent BOUCHIAT is a team leader, former research study senior and primary investigator from French scientific research company CNRS in the field of material scientific research and physics, and he established in 2019 a startup in Grenoble to upcycle his basic deal with the special properties of graphene, permitting the synthesis of electronic polymers with bio-compatibility and biological discovery abilities. Since March 2020, Grapheal has been working with a single-use specific biosensor called 'TestNPass digital Covid Ag examination strip' therefore permitting the rapid detection of SARS-CoV-2. Evidence of concept of the device has been understood by in vitro experiments assembling commercial samples having recombinant structural healthy proteins of the SARS-CoV-2 infection with the discovery electrodes of the disposable antigenic test strip after dilution in a saline service. Examined examples with Nucleocapsid and Spike healthy proteins had the ability to set off an adjustment in conductance, thus permitting detection of the viral surrogate. Encryption of the result within the on-board processing circuits of the device permit the advancement of a device totally compliant with personal data defense and grating GDPR conformity from the beginning. EXPEDIENCY AND PAST EXPERIENCE OF INVOLVED TEAMS: \ n \ nThe group from Grapheal is hosted within the BioPolis incubator facility which presence near Grenoble Teaching Hospital permits for slim cooperations. The virology team from Grenoble University hospital is a pioneer in the growth of molecular based assays for viral analysis. Several of the now classic PCR and RT-PCR widely utilized for routine analysis in France have been set up within our team and research laboratory. These strategies and PCR sets now branded by BioMérieux firm have been established by collaborators from our lab, hence giving us with a large experience in analysis strategy and molecular based technologies. The analysis of SARS-CoV-2 infection is carried out within our research laboratory since the very early days of the pandemic. We have been handling the extremely first infected patients from France as very early as February, 8th 2020. Both medical and microbiological teams from CHUGA have been creating research tasks and data about COVID-19 pandemic. STUDY HYPOTHESIS \ n \ nThe present research has a primary target of demonstrating the feasibility of the Grapheal TestNPass tool to precisely distinguish SARS-CoV-2 infections in a checked population. The origin theory is as adhering to: the bond between the antibody routed against viral healthy proteins and the infection itself suffices to generate within a graphene base semi-conductor a change in conductance that is quantifiable and repeatable. This electrical current can therefore be utilized as a surrogate of viral infection, viral losing and viral infectiousness. Will the primary goal of the here and now study is to show the usefulness of COVID-19 diagnosis with the device, essential performance day such as level of sensitivity, specificity, favorable agreement and adverse contract will be approximated.

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* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions