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

一种医疗保健专业人员使用的用于检测急性COVID19感染的护理点体外诊断测试。这项测试将检测来自医疗保健提供者的SARS-CoV-2病毒的核蛋白抗原-使用手持数字平台收集的鼻甲中拭子。该检测系统连接到一个云平台，以提供公共卫生当局对患者检测结果的实时访问，以进行监测和监测。该测试系统包括：1)建立连接到手持数字平台的一次性测试墨盒2)建立样本采集和处理装置3)建立包含固定体积提取液的可挤压小瓶4)Aellume.Lab，这是一个手持式数字平台，旨在显示测试结果并提供与Ellume的云的连接。5)建立用于实时数据收集、分析和共享的云数据库和界面测试基于Ellume建立的具有数字检测技术的荧光免疫分析试剂盒，并利用专有的荧光生物传感器，通过高灵敏度但完全一次性的光电组件检测和数字化量子点纳米颗粒产生的光信号。ElLume.Lab是Ellume的数字平台，是一种手持智能设备，可以同时读取2个测试墨盒。该设备提供数字用户界面，包括逐步测试说明、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.