Rapid Viral Diagnostic Test by Digital Plasmonic Nanobubbles

项目摘要/摘要：呼吸道病毒是全球公共卫生面临的最严重威胁之一， 部分原因是目前商业上可用的测试的限制： 基于实验室的测试，以及相对较低的灵敏度和特异性的护理点（POS）测试。那里 是对快速、便携和廉价的测试能力的显著需求，该测试能力既高度灵敏又 特定.该项目的广泛的长期目标是开发一种高度敏感的病毒诊断方法， 测试采用Avsana实验室的数字等离子体纳米气泡（数字PNB）计数技术检测 RSV，一种全球重要的病毒，选择用于概念验证研究。病毒检测装置实现传感 病毒颗粒通过其附着到抗体结合的金纳米粒子，采用激光束 在光纤中共对准，以从数字格式的金纳米颗粒产生纳米气泡（存在或 没有大的纳米气泡）。测试将以快速测试周转为特色 时间、高灵敏度和特异性、低成本、便携性和易于使用，这将使其适用于PCR， 包括低资源环境。目的1：开发用于dPNB测定的α原型平台， 便携性和功能性。在一项相关的R 01研究中，使用实验室设置实现了该测定。这一目标将 专注于将光学和电子器件从实验室设置集成到台式便携式设备中， 该平台将整合围绕检测的所有必要信号处理 机制，实现低成本的独立解决方案。目标2：优化分析工作流程和化学 用于检测临床标本基质中的完整RSV病毒。目标是建立一个强大的检测工作流程 和化学检测去识别鼻咽拭子样本中的完整病毒，以便与 Aim 1的alpha原型，并将该技术推向临床使用的可靠诊断测试。 目的3：用去识别临床试验队列测试dPNB测定的灵敏度和特异性。 含有RSV和A型流感病毒标本。的一个重要里程碑 商业化的目的是建立早期检测临床标本中病毒的能力。我们将测试一个小的 60份去识别临床标本的队列，并使用原始实验室设置作为参考。社会 在快速准确的体外病毒病原体检测中， 诊断. Avsana设想PNB平台将有利于季节性呼吸道疾病的管理， 新出现的病毒感染，此外，它将加快大流行的反应，并减少 生活在未来病毒大流行的可能事件中。

Project Summary/Abstract: Respiratory viruses are among the most serious threats to global public health, in part due to the limitations of currently commercially available tests: the high cost and time-consuming nature of lab-based tests, as well as the comparatively lower sensitivity and specificity of point-of-care (PoC) tests. There is a significant need for a rapid, portable, and inexpensive testing capability that is both highly sensitive and specific. The broad, long-term objective of this project is the development of a highly sensitive viral diagnostic test employing Avsana Labs’ digital plasmonic nanobubble (digital PNB) counting technology for detection of RSV, a globally significant virus selected for proof-of-concept studies. The viral test device implements sensing of virus particles by means of their attachment to antibody-conjugated gold nanoparticles, employing laser beams co-aligned in an optical fiber to generate nanobubbles from gold nanoparticles in a digital format (presence or absence of large nanobubbles) with the use of a microfluidic chip. The test will feature a rapid test turnaround time, high sensitivity and specificity, low cost, portability, and ease of use that will make it suitable for the PoC, including low-resource settings. Aim 1: Develop alpha-prototype platform for dPNB assay, demonstrating portability & functionality. In a related R01 study, the assay is realized using a laboratory setup. This aim will focus on miniaturizing optics and electronics from the lab setup into a benchtop-portable device as an alpha- prototype of a PoC platform, which would incorporate all the necessary signal processing around the detection mechanism, enabling a low-cost self-contained solution. Aim 2: Optimize the assay workflow and chemistry for intact RSV virus detection in clinical specimen matrix. The goal is to establish a robust assay workflow and chemistry to detect intact viruses in de-identified nasopharyngeal swab samples, in order to integrate with the alpha-prototype from Aim 1 and advance the technology toward a reliable diagnostic test for use in the clinic. Aim 3: Test the sensitivity and specificity of the dPNB assay with a pilot cohort of de-identified clinical containing RSV and Influenza type A specimens using the alpha-prototype. An important milestone towards commercialization is to establish early-on the ability to detect viruses in clinical specimens. We will test a small cohort of 60 de-identified clinical specimens, and use the original laboratory setup for reference. Societal benefits and broader impact on public health will be found in rapid and accurate in vitro viral pathogen diagnosis. Avsana envisions that the PNB platform will benefit the management of seasonal respiratory and emerging viral infections, and that additionally, it will accelerate the pandemic response and reduce the loss of lives in the likely event of future viral pandemics.