SBIR Phase I: Modular, Paper-based, Secured Diagnostics for Managing Viral Outbreaks (COVID-19)

这个小企业创新研究第一阶段项目的更广泛影响是一种经济高效的方式来管理和跟踪动物、人类和植物种群中的病毒爆发，包括跟踪像新冠肺炎大流行这样的情况。它克服了目前病毒筛查方法的挑战，即收集样本所需的个人防护设备、将样本处理到中央分析地点、测试成本以及对有限试剂的依赖。本项目提出的平台可以在动物生产设施现场使用，也可以在家里使用。扫描仪可以放置在许多市政和商业地点(例如，药店)，或者可以方便地邮寄信封进行评估。双重读取模式向客户端提供及时的反馈，以及匿名聚合读出数据的能力--这对于实时跟踪病毒爆发和通知资源分配以减少传播至关重要。这个诊断平台将产生影响，允许：1)动物生产者减少病毒传播和减少损失；2)企业、学校和其他组织在关闭和健康政策方面做出实时数据驱动的决策。拟议的项目侧重于评估诊断平台三个关键要素的技术可行性：(1)使用定制配方将等温RNA扩增直接耦合到无细胞提取液的能力，以简化可用性(消除当前商业试剂盒的卡外扩增)并降低成本；(2)生产一种可伸缩的、高效的、适合于通过RNA回路扩增报告蛋白的无细胞提取物，以提高蛋白质生产的速度，减少RNA的降解。这种提取物的性能将告知结果的时间以及卡片的成本；以及(3)生产针对与动物行业相关的病毒靶标(例如猪流感、猪呼吸道)的新的脚趾核调节因子(2至3)。这些也将告知探测的限度。该项目将评估此类系统的可行性。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact of this Small Business Innovation Research (SBIR) Phase I Project is a cost-effective way to manage and track viral outbreaks in animal, human, and plant populations, including tracking for situations like the COVID-19 pandemic. It overcomes the challenges of current viral screening methods, namely PPE required for collecting samples, handling of samples to centralized analytic sites, cost of tests, and reliance on limited reagents. The platform proposed in this project could be used on-site at an animal production facility or at home. The scanner can be placed at many municipal and commercial locations (e.g., drug stores) or the envelope can be conveniently mailed for assessment. The dual read modality gives timely feedback to the client, as well as the capability for anonymous aggregation of readout data - essential for real-time tracking of viral outbreak and informing resource allocation to mitigate spread. This diagnostic platform would generate impact, allowing: 1) animal producers to mitigate virus spread and reduce loss and 2) businesses, schools, and other organizations to make real-time data-driven decisions on closures and health policies.The proposed project focuses on assessing technical feasibility of three critical elements of a diagnostic platform: (1) the ability to couple isothermal RNA amplification directly to cell-free extract using custom formulations, to simplify usability (eliminate current off-card amplification with commercial kits) and reduce cost; (2) Production of a scalable and efficient cell-free extract well-suited for amplification of reporter proteins by RNA circuits to increase the rate of protein production and reduced RNA degradation. The performance of this extract will inform the time to result as well as the cost of card, necessary metrics for translation; and (3) production of new toehold riboregulators (2 to 3) selective to virus targets relevant to the animal industry (e.g., swine flu, porcine respiratory). These will also inform the limits of detection. This project will evaluate the feasibility of such as system.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.