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

这项小型企业创新研究（SBIR）一期项目通过结合金纳米颗粒标记、高速流体处理和基于三明治的异质免疫测定以及表面增强拉曼散射（SERS）技术，开发了疱疹病毒诊断平台。疱疹在美国和其他国家已经接近流行病的水平。目前的诊断方法严重限制了对该病病原体，即单纯疱疹病毒1型和2型（单纯疱疹病毒1型和单纯疱疹病毒2型）的广泛水平检测。这一应用反映了市场对高速、低成本测试平台的需求增加，该平台能够量化对诊断至关重要的HSV水平（每毫升样品数十到数百个病毒）。对可靠技术的迫切需求证明了这项研究的广泛影响，这些技术可以作为快速、低成本的分析方法部署，从医生的即时诊断（POC）。S办公室或医院，到实验室检测。目前，超过5000万美国人患有生殖器疱疹，预计每年还会有1%的美国人感染。1999年的一项调查显示，约20%的孕妇检测出HSV-2抗体呈阳性。如果经济和快速的POC检测可以作为产科病房中HSV-2的石蕊试验，那么对于需要剖宫产的疱疹患者，就可以做出更明智的决定，从而保护免疫受损的新生儿。一种能够在特定水平上量化HSV的技术也将在研究人员中找到一席之地。美国实验室评估候选疫苗的抗病毒有效性，以及病理学家确定感染病原体阈值。

This Small Business Innovation Research (SBIR) Phase I project develops a diagnostic platform for herpes viruses by combining gold nanoparticle labels, high-speed fluid handling, and sandwich-based heterogeneous immunoassays with advances in surface enhanced Raman scattering (SERS). Herpes has reached near epidemic levels in the United States and other countries. Current diagnostic approaches severely limit broad level testing of the causative agents of this disease, herpes simplex viruses types 1 and 2 (HSV-1 and HSV-2). This application reflects the increase in market need for a high-speed, low-cost testing platform capable of quantifying HSV levels critical to diagnosis (tens to hundreds of viruses per milliliter of sample). The broader impacts of this research are demonstrated by the urgent need for reliable techniques that can be deployed as rapid, low-cost analysis methods ranging from point-of-care (POC) diagnostics in the doctor?s office or hospital, to laboratory testing. Presently more than 50 million Americans have genital herpes, with another 1% of the U.S. population predicted to become infected annually. A 1999 survey showed ~20% of pregnant women tested positively for HSV-2 antibodies. If economic and rapid POC testing were available as a litmus test for HSV-2 in maternity wards, more informed decisions for herpes necessitated cesarean deliveries could be made, thereby protecting the immune-compromised neonates. A technique capable of quantifying HSV at the noted levels would also find a niche in the researcher?s laboratory in evaluating the antiviral effectiveness of candidate vaccines, as well as by pathologists in defining infective pathogen thresholds.