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。 部分由于目前商业上可用的测试的限制：高成本和耗时的性质 以实验室为基础的测试，以及相对较低的敏感性和特异度的护理(PoC)测试。那里 非常需要一种快速、便携和廉价的测试能力，既要高度敏感，又要 具体的。该项目的广泛、长期目标是开发一种高度敏感的病毒诊断方法。 使用Avsana Labs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，被选作概念验证研究。该病毒检测装置实现了传感 利用激光，通过将病毒颗粒附着在抗体偶联的金纳米颗粒上 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)使用微流控芯片。这项测试将以快速测试为特色 时间、高灵敏度和高特异度、低成本、可移植性和易用性，这将使其适合PoC， 包括低资源环境。目标1：开发dPNB检测的阿尔法原型平台，演示 可移植性和功能性。在一项相关的R01研究中，该分析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设备从实验室设置微型化到台式便携式设备，作为阿尔法- PoC平台的原型，它将围绕检测整合所有必要的信号处理 机制，实现低成本的自给自足的解决方案。目标2：优化检测工作流程和化学成分 用于检测临床标本基质中完整的RSV病毒。我们的目标是建立一个强大的分析工作流程 和化学来检测未识别的鼻咽拭子样本中的完整病毒，以便与 来自Aim 1的阿尔法原型，并将该技术推向临床使用的可靠诊断测试。 目的3：用一组初步确定的临床队列来测试dPNB检测的敏感性和特异性 包含使用阿尔法原型的RSV和A型流感样本。一个重要的里程碑，朝着 商业化就是尽早建立在临床标本中检测病毒的能力。我们将测试一个小的 队列60个未鉴定的临床标本，并参考原有的实验室设置。社会性 快速、准确的体外病毒病原体将对公众健康产生好处和更广泛的影响 诊断。Avsana设想，PNB平台将有利于季节性呼吸和呼吸疾病的管理 新出现的病毒感染，此外，它还将加快对大流行的反应，减少 生活在未来可能发生的病毒大流行中。