SBIR Phase II: Sensitive, Rapid Heterogeneous Immunoassays Based on Surface Enhanced Raman Scattering and Gold Nanoparticle Labels

这个小型企业创新研究(SBIR)第二阶段项目继续开发基于表面增强拉曼散射(SERS)的创新诊断技术，将其与金纳米颗粒标记、高速流体处理和基于三明治的免疫分析相结合。该项目建立在SBIR第一阶段工作的成功基础上，反映了市场对高速、低成本测试的明确需求，能够提供与临床诊断需求相称的快速结果。作为一个市场切入点，首要目标是为疱疹的病原体：1型单纯疱疹病毒和2型单纯疱疹病毒(HSV-1和HSV-2)创建一个可扩展的、多路诊断平台。在美国和世界其他国家，疱疹已经达到接近大流行的水平。这种检测平台的开发将在从医生办公室和医院内POC到第三方临床诊断实验室的诊断市场上具有明显的效用，作为性传播疾病和其他疾病的多路平台。这项研究的更广泛影响随着能够提供HSV和许多其他病毒疾病绝对定量的技术的开发而实现。这种诊断工具将在大型临床实验室、评估候选疫苗抗病毒效果的研究实验室以及确定感染病原体阈值的病理学家中找到一席之地，为这项技术成为诊断技术武器库中的主要工具之一奠定基础。

This Small Business Innovation Research (SBIR) Phase II project continues the development of an innovative diagnostic technology based on surface-enhanced Raman scattering (SERS) through its combination with gold nanoparticle labels, high-speed fluid handling, and sandwich-based immunoassays. This project, which builds on the successes of the SBIR Phase I effort, reflects a clear market need for high-speed, low-cost testing capable of providing rapid results commensurate with clinical diagnostic demands. As a market-entry point, the overarching goal is to create an extensible, multiplexed diagnostics platform for the causative agents of herpes: herpes simplex virus type 1 and type 2 (HSV-1 and HSV-2). Herpes has reached near pandemic levels in the United States and other countries around the world. The development of such a detection platform would have clear utility across the diagnostics marketplace, from the physician's office and in-hospital POC to third-party clinical diagnostic laboratories, as a multiplexed platform for sexually transmitted diseases and beyond.The broader impacts of this research are realized with the development of a technique capable of providing absolute quantitation of HSV and many other viral diseases. Such a diagnostic tool would find a niche in large clinical laboratories, in research laboratories evaluating the antiviral efficacy of candidate vaccines, and with pathologists for defining infective pathogen thresholds, setting the stage for this technology to emerge as one of the premier tools in an arsenal of diagnostic technologies.