I-Corps: Integrated System for Rapid Pathogen Enrichment and Detection

这个I-Corps项目的更广泛的影响/商业潜力解决了对快速，准确和高通量诊断测试平台的需求。鉴于这一需求的紧迫性，该团队的第一个产品旨在通过在几分钟内从患者鼻拭子进行即时诊断来支持正在进行的SARS-CoV-2疾病诊断。尽管该疾病的流行和快速传播，但大多数诊断测试仍然是时间密集型的，需要大量的外部试剂，和/或在感染的早期阶段缺乏检测灵敏度。该团队假设该技术在这一领域具有重要价值，并有兴趣通过I-Corps更彻底地探索这种潜在价值。该技术还可以应用于传统上依赖于基于培养的检测和/或核酸扩增技术的其他诊断市场。该平台可以处理复杂的生物流体和大体积样品，这可以转化为一系列生物流体中的病原体检测，包括尿液、唾液和滑液，分别用于检测尿路感染、呼吸道感染和关节感染。还有一些潜在的非医疗应用，包括食品和水质监测，生物安全监测，以及应用到护理点。这个I-Corps项目的重点是了解市场对该平台的需求，该平台执行纳米级病原体富集和检测（nano-PED）。对于传染病，目前的诊断方法仍然非常耗时、昂贵，并且依赖于劳动密集型样品制备步骤，随后是用于病原体鉴定和表征的额外步骤。 该平台旨在：1）通过从患者的生物流体样品中直接分离罕见病原体来避免费力的样品制备步骤，以及2）通过超灵敏的序列特异性核酸检测来消除对分子扩增的需要。更具体地说，nano-PED利用纳米颗粒的各种科学应用，将病原体捕获和物种特异性检测集成到单个芯片上。该技术是一种微型平台，可从患者样本中分离细菌、真菌和/或病毒，并通过超灵敏的核酸表征识别致病病原体。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值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 I-Corps project addresses the need for rapid, accurate, and high-throughput diagnostic testing platforms. Given the urgency of this need, the team's first product aims to support ongoing SARS-CoV-2 disease diagnosis by enabling point-of-care diagnosis from a patient nasal swab within minutes. Despite the prevalence and rapid spread of the disease, the majority of diagnostic tests remain time intensive, require numerous external reagents, and/or lack detection sensitivity in the early stages of infection. The team hypothesizes that the technology has significant value in this space and is interested in exploring this potential value more thoroughly through I-Corps. The technology may also find application to other diagnostic markets that traditionally rely on culture-based detection and/or nucleic acid amplification technologies. The platform can process complex biofluids and large volume samples, which could translate to pathogen detection in a range of biological fluids, including urine, saliva, and synovial fluid for the detection of urinary tract infections, respiratory infections, and joint infections, respectively. There are also a number of potential non-medical applications, including food and water quality monitoring, biosecurity surveillance, and applications to the point-of-care.This I-Corps project focuses on understanding the market need for the platform, which performs nanoscale Pathogen Enrichment and Detection (nano-PED). For infectious disease, current diagnostic methodologies remain extremely time-consuming, costly, and rely on labor intensive sample preparation steps, followed by additional steps for pathogen identification and characterization. The platform aims to: 1) circumvent laborious sample preparation steps through direct isolation of rare pathogens from a patient's biofluid sample, and 2) eliminate the need for molecular amplification through ultrasensitive, sequence-specific nucleic acid detection. More specifically, nano-PED capitalizes on the diverse scientific applications of nanoparticles to integrate pathogen capture and species-specific detection onto a single chip. The technology is a micro-scale platform that isolates bacteria, fungi, and/or virus from a patient sample and identifies the disease-causing pathogen through ultrasensitive nucleic acid characterization.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.