Rapid and Simple Paper Strip Test for the Multiplexed Detection of Gastrointestinal Pathogens at the Point-of-Need

快速、简单的纸条测试，用于在需要时多重检测胃肠道病原体

• 批准号: 10255421
• 负责人: Chang Hee Kim
• 金额: $ 59.78万
• 依托单位: GODX, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-11-01 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10255421
• 关键词: COVID test; COVID-19; COVID-19 detection; COVID-19 test; Cessation of life; Clinical; DNA; Detection; Devices; FDA Emergency Use Authorization; Funding; Hospitals; Laboratories; Paper; Patients; Physicians' Offices; RNA; RNA Viruses; Resources; Reverse Transcriptase Polymerase Chain Reaction; Sampling; Small Business Innovation Research Grant; Technology; Testing; United States; Validation; Virus; antigen test; commercialization; cost; gastrointestinal; instrument; multiplex detection; pandemic disease; parent grant; pathogen; prototype; test strip

PROJECT SUMMARY GoDx, Inc. has been developing a prototype multiplexed paper strip device for the detection of the DNA and RNA of gastrointestinal pathogens at the point-of-need in < 30 minutes with funding from the NCATS SBIR parent grant TR 001912. We have used the same platform technology we are developing in the parent grant to develop a rapid (<30 minute), low-cost and instrument-free paper strip test for SARS-CoV-2 that can be performed in a wide range of settings. Our tests are more sensitive than the antigen tests since the RNA of the virus are exponentially amplified. The value proposition of this test is that it is fast and readily available to the patient (30 minutes at the doctor's office with a simple, physician's office laboratory vs 2-3 days sending samples to a laboratory) which allows faster isolation and treatment of the patient. Our test will also be valuable in laboratories and hospitals with limited resources in the developed and the developing world that do not have an RT-PCR instrument to test for coronavirus. We propose the commercialization of a simple, rapid, ow-cost and instrument-free test to detect SARS-CoV-2. We will perform the analytical and clinical validation required for the FDA Emergency Use Authorization (EUA). We will also manufacture and commercialize our test.

项目摘要 Godx，Inc。一直在开发一种原型多路复用纸条设备，以检测 在<30分钟内，胃肠道病原体的DNA和RNA与 NCATS SBIR父母赠款TR 001912的资金。我们使用了同一平台 我们正在父母赠款中开发的技术，以开发快速（<30分钟），低成本和 SARS-COV-2的无仪器纸带测试，可以在各种范围内执行 设置。我们的测试比抗原测试更敏感，因为病毒的RNA是 呈指数增大。该测试的价值主张是它快速且容易可用 病人（在医生办公室30分钟，有一个简单的医师办公室实验室vs 2-3 将样品发送到实验室的天数），这可以更快地隔离和治疗患者。 我们的测试也将在实验室和医院中有价值 发达的以及没有RT-PCR工具来测试的发展中国家 新冠病毒。我们提出了简单，快速，ow且无仪器的商业化 测试以检测SARS-COV-2。我们将执行所需的分析和临床验证 FDA紧急使用授权（EUA）。我们还将制造和商业化我们的 测试。