RADX TECH XTRAVA, INC. - SPERA COVID-19 AG TESTRAPID ACCELERATION OF DIAGNOSTICS (RADX) PROGRAM: TECH PROJECT #5834 XTRAVA, INC.

RADX TECH XTRAVA, INC. - SPERA COVID-19 AG TESTRAPID 诊断加速 (RADX) 计划：技术项目

• 批准号: 10505998
• 负责人: SAMEH SARHAN
• 金额: $ 620.7万
• 依托单位: XTRAVA, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-04 至 2022-03-03
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10505998
• 关键词: Acceleration; COVID-19; COVID-19 diagnosis; Clinic; Consumption; Diagnostic; Diagnostic tests; Economics; Health; Health Personnel; Health Professional; Home; Influenza A Virus, H1N1 Subtype; Legal patent; Manuals; Monitor; Population; Positioning Attribute; RADx; RADx Tech; Rapid diagnostics; Reader; System; Technology; Testing; Time; Validation; Walking; Wireless Technology; authority; cost; design; digital; handheld mobile device; large scale production; lateral flow assay; machine vision; manufacturing scale-up; nasal swab; novel; point of care; programs; saliva sample; self testing

Mitigating the economic and health challenges of COVID-19 is hindered by the absence of mass population testing. Available platforms are designed for lab-use and rely on sophisticated technologies and readers. They are slow, expensive, hard to manufacture and overload healthcare professionals with time consuming manual workflows; presenting massive obstacles to high throughput testing.  We introduce a novel platform to diagnose COVID-19, which includes a digital test that combines fluorescent lateral flow assays with our patent-pending cost-optimized lateral flow test platform which was initially developed to detect H1N1.  We have formed the essential alliances with key partners to rapidly scale up manufacturing and distribution to the points-of-need. Nasal swabs (and soon saliva samples) are tested in under 15 minutes. The digital results are wirelessly communicated to the participants’ mobile devices and the cloud thereby providing healthcare providers with test status and sharing real-time analytics and monitoring capabilities with health authorities. In the first stage, the test will be deployed into CLIA-waived point-of-care clinics, walk-in facilities and drive-thru testing centers for less than $35 for the digital test and with an effective cost of less than $10 per disposable test.   After full validation, we will immediately extend deployment to at-home use by leveraging machine vision-guided self-testing. By combining IoT technologies that are proven to enable large-scale production with rapid diagnostic testing we believe we are uniquely positioned to increase testing throughput by 10X-100X. RADx re-enforcement will propel the launch of the system in highly condensed timeframes to meet the enormous need.

由于缺乏大规模人群检测，缓解 COVID-19 带来的经济和健康挑战受到阻碍。可用平台专为实验室使用而设计，依赖于复杂的技术和读取器。它们速度慢、成本高、难以制造，并且耗时的手动工作流程使医疗保健专业人员超负荷；给高通量测试带来巨大障碍。  我们推出了一种诊断 COVID-19 的新颖平台，其中包括将荧光侧流检测与我们正在申请专利的成本优化侧流测试平台相结合的数字测试，该平台最初是为检测 H1N1 而开发的。  我们与主要合作伙伴建立了重要的联盟，以快速扩大制造和分销以满足需求。鼻拭子（很快还有唾液样本）可在 15 分钟内完成检测。数字结果通过无线方式传输到参与者的移动设备和云，从而为医疗保健提供者提供测试状态并与卫生当局共享实时分析和监控功能。在第一阶段，该测试将部署到 CLIA 豁免的现场护理诊所、步入式设施和得来速测试中心，数字测试的费用不到 35 美元，每次一次性测试的有效成本不到 10 美元。   全面验证后，我们将立即利用机器视觉引导的自测试将部署扩展到家庭使用。通过将已被证明能够实现大规模生产的物联网技术与快速诊断测试相结合，我们相信我们具有独特的优势，可以将测试吞吐量提高 10 倍至 100 倍。 RADx 的强化将推动该系统在高度紧凑的时间内启动，以满足巨大的需求。