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

SBIR 第一阶段：基于抗原的快速 SERS 检测，用于 COVID-19 检测 (COVID-19)

• 批准号: 2031056
• 负责人: Joel Tabb
• 金额: $ 25.55万
• 依托单位: Ionica Sciences
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-01 至 2021-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2031056&HistoricalAwards=false
• 关键词: SBIR; Phase; Rapid; Antigen; based

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.

这一小型企业创新研究（SBIR）第一阶段项目的更广泛影响和商业潜力是允许使用快速和高度准确的诊断测试对潜在的COVID-19患者进行测试，特别是对无症状的患者。这将通过防止这些患者无意中感染其家庭和社区成员，在病例数量的“平坦曲线”方面提供显著优势。目前的协议需要几天时间才能返回结果，这给公共卫生带来了问题。 该测试是使用基础平台技术可以产生的许多测试中的第一个，将提高：1）快速识别患有活动性COVID-19病例的患者的能力，以便迅速进行临床干预，减少该患者的传播;以及2）由于更高的性能和准确性而产生的结果。这个小型企业创新研究（SBIR）第一阶段项目解决了在患者附近缺乏快速，准确的COVID-19检测的问题。这项工作将开发一个传染病平台，它结合了：1）DNA适体，一种靶蛋白的识别元件; 2）表面增强拉曼散射（Sers），一种振动光谱检测方法; 3）正交偏最小二乘差分分析，一种经常应用于振动光谱分析的成熟统计方法。通过使用靶向SARS-CoV-2相关蛋白的适体，（例如，刺突（S）蛋白），预期该测定在收集口咽或鼻咽样品后30分钟内鉴定该蛋白的存在，最终预计达到95%临床敏感性和特异性。该奖项反映了NSF的法定使命，并已被认为是值得通过评估使用基金会的支持，知识价值和更广泛的影响审查标准。