SBIR Phase I: A Versatile Nucleic Acid Collection and Purification Technology for Wastewater-Based Epidemiology

小型企业创新研究(SBIR)第一阶段项目的更广泛影响/商业潜力是为私营和公共利益攸关方提供新的技术工具，以更好地监测和预测流行病。该项目预计将使私人和公共实验室目前用于测试和诊断目的的工具现代化，以收集和提纯病原体，特别是来自社区废水的人类冠状病毒。预计新的技术工具将简化工作流程，减少成本和时间，并能够在观察临床病例的几周前预测新冠肺炎疫情和其他流行病。这样的早期预测将为公众和政府机构提供重要数据和足够的时间采取预防措施。该项目的技术产品预计将支持越来越多的提供废水流行病学(WBE)服务的公司和实验室，并帮助将WBE建立为常规、经济高效和可靠的公共卫生监测工具。这一小型企业创新研究(SBIR)第一阶段项目将解决在废水中检测SARS-CoV-2病毒的主要技术障碍。商业上可用的核酸采集和纯化试剂盒是为小体积的临床样本设计的。这些试剂盒通常不适用于病毒浓度较低的大容量废水。因此，目前的过程非常耗时，导致病毒和核酸的回收率不到30%，大大降低了灵敏度。这个SBIR第一阶段项目的目标是论证一种从废水中收集和纯化病毒和核酸的新技术的可行性。具体地说，项目任务旨在加强对病毒特性的了解，特别是废水中的人类冠状病毒及其与过滤介质的相互作用。该项目的创新方法是设计一种简化的工作流程，其中包括从样本收集到检测的所有步骤，在一个一次性墨盒中包含对病毒具有高度亲和力的新型过滤器。这一进展有望将废水中病毒和核酸的回收率提高到90%以上，同时降低成本。开发的工具将由第三方实验室进行独立测试和评估，以确认其性能。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/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to provide private and public stakeholders with new technological tools to better monitor and predict pandemics. This project is expected to modernize the tools used today by private and public laboratories to collect and purify pathogens, particularly human coronaviruses from community wastewater, for testing and diagnostic purposes. The new technological tools are expected to simplify the workflow, reduce costs and time, and enable the prediction of COVID-19 outbreaks and other pandemics several weeks before observing clinical cases. Such early prediction would provide the public and government agencies with important data and sufficient time to take preventive measures. The technological products of this project are expected to empower the growing number of companies and laboratories offering wastewater-based epidemiology (WBE) services and help establish WBE as a routine, cost-effective and reliable tool for public health monitoring.This Small Business Innovation Research (SBIR) Phase I project will address a major technological barrier for the detection of viruses such as SARS-CoV-2 in wastewater. Commercially available nucleic acid collection and purification kits are designed for clinical samples with small volumes. These kits are not generally used for large wastewater volumes where the virus is present at low concentrations. As a result, current processes are time-consuming, and result in the recovery of less than 30% of viruses and nucleic acids, significantly reducing the sensitivity. The goal of this SBIR Phase I project is to demonstrate the feasibility of a novel virus and nucleic acid collection and purification technology from wastewater. Specifically, the project tasks aim at enhancing understanding of virus properties, particularly human coronaviruses in wastewater and their interactions with filter media. The project’s innovative approach is to design a streamlined workflow that includes all the steps from sample collection to detection, in a single disposable cartridge containing novel filters with high affinity to viruses. This development is expected to enhance viral and nucleic acid recovery in wastewater to over 90%, while reducing costs. The developed tools will be independently tested and evaluated by third-party laboratories to confirm their performance.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.