Rapid Viral Diagnostic Test by Digital Plasmonic Nanobubbles

利用数字等离子体纳米气泡进行快速病毒诊断测试

• 批准号: 10547200
• 负责人: Zhenpeng Qin
• 金额: $ 30万
• 依托单位: AVSANA LABS INCORPORATED
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-14 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10547200
• 关键词: Binding Proteins; Biological Assay; Biomedical Research; Biosensor; Categories; Chemistry; Clinic; Clinical; Clinical Sensitivity; Communicable Diseases; Complex; Consumption; Coupling; Data; Detection; Development; Devices; Diagnosis; Diagnostic; Diagnostic Equipment; Diagnostic tests; Dimensions; Early Diagnosis; Electronics; Engineering; Event; Future; Goals; Grant; Human; Immunoassay; In Vitro; Influenza; Laboratories; Lasers; Legal patent; Life; Measurement; Methods; Microfluidic Microchips; Molecular; Mucolytics; National Institute of Allergy and Infectious Disease; Nature; Optics; Performance; Phase; Physiologic pulse; Population; Preparation; Public Health; RNA; Rapid diagnostics; Research; Resource-limited setting; Respiratory syncytial virus; Risk; Sampling; Sensitivity and Specificity; Severities; Signal Transduction; Small Business Technology Transfer Research; Specificity; Specimen; System; Technology; Temperature; Test Result; Testing; Texas; Time; Universities; Validation; Viral; Virion; Virus; Virus Diseases; Work; antibody conjugate; base; cohort; commercialization; comorbidity; comparative; computerized data processing; coronavirus disease; cost; cost effective; design; detection platform; diagnostic platform; diagnostic value; digital; falls; in-vitro diagnostics; innovation; miniaturize; nanoGold; nanobubble; nanoparticle; nasopharyngeal swab; optical fiber; pandemic disease; particle; pathogen; pathogenic virus; plasmonics; point of care; point of care testing; point-of-care diagnostics; portability; prototype; rapid test; research and development; respiratory; respiratory virus; response; signal processing; success; vapor; viral detection

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.

项目摘要/摘要：呼吸道病毒是对全球公共卫生最严重的威胁之一， 部分原因是目前商用测试的局限性：成本高且耗时 基于实验室的测试，以及相对较低的敏感性和特异性的即时 (PoC) 测试。那里 迫切需要一种快速、便携且廉价的测试能力，该能力既要​​高度灵敏，又要 具体的。该项目的广泛、长期目标是开发高度敏感的病毒诊断方法 测试采用 Avsana Labs 的数字等离子体纳米气泡（数字 PNB）计数技术来检测 RSV，一种全球重要的病毒，被选用于概念验证研究。病毒检测装置实现传感 利用激光束将病毒颗粒附着在抗体偶联的金纳米颗粒上 在光纤中共同排列，以数字格式（存在或存在）从金纳米粒子生成纳米气泡 没有大的纳米气泡）并使用微流控芯片。该测试将具有快速的测试周转 时间、高灵敏度和特异性、低成本、便携性和易用性，使其适合 PoC， 包括资源匮乏的环境。目标 1：开发 dPNB 检测的 alpha 原型平台，展示 便携性和功能性。在相关的 R01 研究中，该测定是使用实验室设置实现的。这一目标将 专注于将光学和电子器件从实验室装置小型化为台式便携式设备，作为阿尔法- PoC 平台的原型，它将包含围绕检测的所有必要的信号处理 机制，实现低成本的独立解决方案。目标 2：优化检测工作流程和化学反应 用于临床样本基质中完整 RSV 病毒的检测。目标是建立强大的检测工作流程 和化学检测去识别的鼻咽拭子样本中的完整病毒，以便与 来自 Aim 1 的 alpha 原型，并将该技术推进到临床上使用的可靠诊断测试。 目标 3：通过未识别的临床试验队列测试 dPNB 测定的敏感性和特异性 使用 alpha 原型包含 RSV 和 A 型流感样本。一个重要的里程碑 商业化的目的是尽早建立检测临床标本中病毒的能力。我们将测试一个小 60个去鉴定的临床标本的队列，并使用原始实验室设置作为参考。社会的 快速、准确的体外病毒病原体将带来好处和对公共健康更广泛的影响 诊断。 Avsana 预计 PNB 平台将有利于季节性呼吸和疾病的管理 新出现的病毒感染，此外，它将加速大流行应对并减少损失 生活在未来可能发生的病毒大流行的情况下。