SBIR Phase I: Rapid Antigen-based SERS assay for COVID-19 Detection (COVID-19)

这个小企业创新研究第一阶段项目的更广泛的影响和商业潜力是允许使用快速和高精度的诊断测试来测试潜在的新冠肺炎患者，特别是对于没有症状的患者。这将通过防止这些患者不经意地感染他们的家人和社区成员，在平坦化病例数量方面提供显著的优势。目前的协议需要数天才能返回结果，这给公共卫生带来了问题。这是使用底层平台技术可以产生的许多测试中的第一个，它将提高：1)快速识别新冠肺炎活跃病例患者的能力，以便进行快速临床干预，减少患者的传播；以及2)由于更高的性能和准确性而产生的结果。这一小型企业创新研究第一阶段项目解决了在近患者环境下缺乏对新冠肺炎进行快速、准确测试的问题。这项工作将开发一个传染病平台，它结合了：1)DNA适配子，目标蛋白质的识别元件；2)表面增强拉曼散射(SERS)，一种振动光谱检测方法；3)和正交偏最小二乘微分分析，这是一种成熟的统计方法，通常用于基于振动光谱的分析。通过使用针对SARS-CoV-2相关蛋白(例如，SPEKE(S)蛋白)的适体，该检测有望在采集口腔或鼻咽样本后30分钟内确定该蛋白的存在，最终有望达到95%的临床灵敏度和特异度。该奖项反映了美国国家科学基金会的法定使命，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 and commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to allow testing of potential COVID-19 patients using a rapid and highly accurate diagnostic test, particularly for patients who are asymptomatic. This will provide a significant advantage in “flattening the curve” of the number of cases by preventing these patients from inadvertently infecting their family and community members. Current protocols require days to return a result, creating problems for public health. This test, the first of many that can be produced using the underlying platform technology, would improve: 1) the ability to rapidly identify patients with active COVID-19 cases for expeditious clinical intervention, reducing transmission by that patient; and 2) outcomes because of the higher performance and accuracy. This Small Business Innovation Research (SBIR) Phase I project addresses the lack of rapid, accurate testing for COVID-19 in near patient settings. This effort will develop an infectious disease platform that combines: 1) DNA aptamers, a recognition element for target proteins; 2) surface enhanced Raman scattering (SERS), a vibrational spectroscopic detection method; 3) and orthogonal partial least squares differential analysis, a well-established statistical method often applied to vibrational spectroscopy-based analyses. By employing aptamers that target SARS-CoV-2 related proteins (e.g. the spike (S) protein), this assay is anticipated to identify the presence of this protein under 30 minutes after oro- or naso-pharyngeal sample is collected, and is ultimately expected to achieve 95% clinical sensitivity and specificity.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.