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公司一直在开发一种原型多路复用纸条设备，用于检测 胃肠道病原体的DNA和RNA在需要时在< 30分钟内， NCATS SBIR母基金TR 001912的资助。我们使用同一个平台 技术，我们正在开发的家长补助金，以开发一个快速（<30分钟），低成本， SARS-CoV-2的无仪器试纸测试，可以在广泛的 设置.我们的测试比抗原测试更敏感，因为病毒的RNA是 呈指数级放大此测试的价值主张是，它快速且易于使用， 患者（30分钟在医生的办公室与一个简单的，医生的办公室实验室与2-3 将样本送至实验室的时间为30天），这允许更快地隔离和治疗患者。 我们的测试也将是有价值的实验室和医院资源有限， 发达国家和发展中国家没有RT-PCR仪器来测试 冠状病毒。我们建议将一种简单、快速、低成本、无需仪器的 检测SARS-CoV-2。我们将进行所需的分析和临床验证， FDA紧急使用授权（EUA）。我们还将生产和商业化我们的 test.