RADX-TECH - ELLUME USA, LLC COVID-19 ANTIGEN TEST FOR THE DIRECT DETECTION OF THE SARS COV-2 VIRUS.

A point-of-care, in vitro diagnostic test for the detection of an acute COVID 19 infection for use by healthcare professionals. The test will detect the nucleoprotein antigen of the SARS-CoV-2 virus from a healthcare provider-collected mid-turbinate nasal swab using a hand-held digital platform. The test system is connected to a cloud platform to provide real time access to patient test results by public health authorities for surveillance and monitoring. The test system includes: 1)    a single-use test cartridge that connects to the hand-held digital platform 2)    a sample collection and processing device 3)    a squeezable vial containing a fixed volume of extraction fluid 4)    ellume.lab, a hand-held digital platform designed to display test results and provide connectivity to Ellume's cloud. 5)    a cloud database and interface for real time data collection, analytics and sharing The test is based on Ellume's established fluorescent immunoassay cartridge with digital detection technology, and leverages a proprietary fluorescence biosensor, with a light signature produced by quantum dot nanoparticles detected and digitized by a highly sensitive but fully disposable optoelectronics package. Ellume.lab, Ellume's digital platform, is a hand-held smart device that can read 2 test cartridges at a time. The device provides a digital user interface and includes step-by-step test instructions, digital interpretation of test results, and is connected to Ellume's cloud platform. The device also connects to the clinic's electronic medical record (EMR) system. The device requires no calibration or maintenance, and is battery operated with over 24 hours use before requiring charging.