Feasibility and Analytic Performance of TestNPass (IVDMD) for CoViD-19 Diagnosis on Saliva Sample

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.