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

项目总结 GoDx，Inc.一直在开发一种多路传输纸条设备的原型，用于检测 胃肠道病原体DNA和RNA在30分钟内的危急时刻 资金来自NCATS SBIR家长赠款tr 001912。我们使用了相同的平台 我们在母公司赠款中正在开发的技术，以开发快速(&lt；30分钟)、低成本和 SARS-CoV-2免仪器纸条检测，适用范围广 设置。我们的检测比抗原检测更敏感，因为病毒的RNA是 成倍放大。此测试的价值主张是，它快速且随时可用来 患者(30分钟在医生办公室与简单的医生办公室实验室对比2-3分钟 将样本送到实验室的天数)，从而可以更快地隔离和治疗患者。 我们的测试在实验室和医院资源有限的情况下也将很有价值 发达国家和发展中国家没有可供检测的RT-PCR仪器 冠状病毒。我们提出了一种简单、快速、低成本、免仪器的商业化 检测SARS-CoV-2的试验。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 测试。

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.