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: 10665073
• 负责人: Zhenpeng Qin
• 金额: $ 29.64万
• 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 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10665073
• 关键词: Acceleration; 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; Fiber Optics; Future; Goals; Grant; Human; Immunoassay; In Vitro; Influenza A virus; Laboratories; Lasers; Legal patent; Life; Marketing; 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; Seasons; 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; cohort; commercialization; comorbidity; comparative; computerized data processing; coronavirus disease; cost; cost effective; current pandemic; design; detection platform; diagnostic platform; diagnostic value; digital; digital platform; fabrication; falls; improved; in-vitro diagnostics; innovation; nanoGold; nanobubble; nanoparticle; nasopharyngeal swab; optical fiber; pandemic response; 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; signal processing; success; vapor; viral detection; viral pandemic

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 部分由于当前可商购测试的局限性：高成本和耗时的性质 基于实验室的测试以及相对较低的敏感性和护理点（POC）测试的特异性。那里 是对快速，便携式和廉价测试能力的重要需求，既高敏感又 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 使用Avsana Labs的数字等离子体纳米泡（Digital PNB）计数技术进行测试，以检测 RSV是一种全球重要的病毒，可用于概念验证研究。病毒测试装置实现灵敏度 通过使用激光束，通过其附着在抗体偶联的金纳米颗粒上的病毒颗粒 在光纤中共对准，以数字格式（存在或 使用微流体芯片，没有大纳米泡）。该测试将具有快速测试周转 时间，高灵敏度和特异性，低成本，可移植性和易用性，使其适合POC， 包括低资源设置。目标1：开发DPNB测定的α-型平台，证明 便携性和功能。在相关的R01研究中，该测定方法是使用实​​验室设置实现的。这个目标 专注于将实验室设置的光学和电子设备作为alpha- POC平台的原型，该平台将结合检测周围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：优化测定工作流程和化学 对于完整的RSV病毒检测，在临床标本基质中。目的是建立强大的组装工作流程 和化学以检测去识别的鼻咽拭子样品中的完整病毒，以便与 AIM 1的Alpha-蛋白质并将技术推向可靠的诊断测试，以便在诊所使用。 AIM 3：测试DPNB测定的灵敏度和特异性，并通过降低临床的试点队列 使用Alpha-Prototype含有RSV和流感A型标本。一个重要的里程碑 商业化是在临床规格中检测病毒的能力早期建立。我们将测试一个小的 队列的60个去识别的临床标本，并使用原始实验室设置进行参考。社会 在快速，准确的体外病毒病原体中，将发现对公共卫生的好处和更广泛的影响 诊断。 Avsana设想PNB平台将受益于季节性呼吸道管理和 新兴的病毒感染，此外，它将加速大流行反应并减少 生活在未来病毒大流行病的可能性中。