SBIR Phase I: 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)第一阶段项目将金纳米颗粒标记、高速流体处理和基于三明治的异种免疫分析与表面增强拉曼散射(SERS)技术的进步相结合，开发了一个针对疱疹病毒的诊断平台。在美国和其他国家，疱疹已经接近流行水平。目前的诊断方法严重限制了对这种疾病的病原体--1型和2型单纯疱疹病毒(HSV-1和HSV-2)的广泛检测。这一应用反映了市场对高速、低成本测试平台的需求的增加，该平台能够量化对诊断至关重要的HSV水平(每毫升样本中有数十到数百种病毒)。这项研究的更广泛影响体现在对可靠技术的迫切需求上，这些技术可以作为快速、低成本的分析方法部署，范围从医生S办公室或医院的看护点(POC)诊断到实验室测试。目前，美国有5000多万人患有生殖器疱疹，预计每年还会有1%的美国人口受到感染。1999年的一项调查显示，约20%的孕妇HSV-2抗体检测呈阳性。如果经济和快速的POC检测可以作为产科病房HSV-2的试金石，就可以对需要剖腹产的疱疹做出更明智的决定，从而保护免疫功能低下的新生儿。一种能够在所指出的水平上量化单纯疱疹病毒的技术也将在研究员S的实验室中找到合适的位置，以评估候选疫苗的抗病毒效果，以及病理学家在确定感染病原体阈值方面的优势。

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.