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

用于检测急性COVID 19感染的即时体外诊断测试，供医疗保健专业人员使用。该测试将使用手持式数字平台从医疗保健提供者收集的中鼻甲鼻拭子中检测SARS-CoV-2病毒的核蛋白抗原。测试系统连接到云平台，以提供公共卫生当局对患者测试结果的真实的访问，以进行监视和监测。测试系统包括：1） 连接到手持式数字平台的一次性测试盒2） 样品收集和处理装置3） 容纳固定体积的提取液的可挤压小瓶4） ellume.lab是一个手持式数字平台，旨在显示测试结果并提供与Ellume云的连接。第五章） 用于真实的时间数据收集、分析和共享的云数据库和界面该测试基于Ellume已建立的具有数字检测技术的荧光免疫分析盒，并利用专有的荧光生物传感器，由量子点纳米颗粒产生的光信号由高度敏感但完全一次性的光电封装检测和数字化。Ellume的数字平台Ellume.lab是一款手持式智能设备，可以一次读取2个测试盒。该设备提供了一个数字用户界面，包括一步一步的测试说明，测试结果的数字解释，并连接到Ellume的云平台。该设备还连接到诊所的电子病历（EMR）系统。该设备不需要校准或维护，并且在需要充电之前使用电池超过24小时。

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.