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

这个小企业创新研究（SBIR）二期项目继续开发一种基于表面增强拉曼散射（SERS）的创新诊断技术，该技术结合了金纳米颗粒标记、高速流体处理和三明治免疫分析。该项目建立在SBIR第一阶段工作的成功基础上，反映了市场对能够提供与临床诊断需求相称的快速结果的高速、低成本测试的明确需求。作为市场切入点，总体目标是创建一个可扩展的多路诊断平台，用于疱疹病原体：1型和2型单纯疱疹病毒（HSV-1和HSV-2）。疱疹在美国和世界其他国家已经达到了接近大流行的程度。这种检测平台的开发将在整个诊断市场中具有明确的效用，从医生办公室和医院POC到第三方临床诊断实验室，作为性传播疾病等的多路平台。随着一种能够提供HSV和许多其他病毒性疾病的绝对定量的技术的发展，这项研究的更广泛影响得以实现。这种诊断工具将在大型临床实验室、评估候选疫苗抗病毒功效的研究实验室以及病理学家确定感染性病原体阈值中找到一个利基，为这项技术成为诊断技术武器库中的首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.