SBIR Phase I: Personalized Point-of-Care Immunity Assessment Platform

该小型企业创新研究（SBIR）第一阶段项目将创建一个多路复用的护理点（POC）测试平台，用于使用全血样本评估和验证疫苗接种。 为了快速评估免疫状态，准确的多重检测和从全血中分离血浆都对POC检测系统构成了技术障碍。 侧流免疫测定在从全血样品获得多重结果方面受到限制。 在足够的样品体积中从血液中分离血浆，以及来自邻近免疫反应的干扰，为开发有效的POC免疫试验造成了重大的技术障碍。 此外，免疫的表位特异性评估尚未在这种测试中得到证实。 本提案的目的是创建一种血浆生成多重表位特异性测试装置，用于测试对病毒性疾病的免疫力。第一阶段项目将在适当的硝酸纤维素表面上建立与血液分离材料一致的最佳、非干扰的肽阵列配置。同时，该公司将利用表位作图技术。多个疫苗应答表位的阐明，以及肽亲和捕获类似物的设计和验证，以实现循环疫苗应答抗体的定量，对于创建准确的血清学检测是必不可少的。该项目的更广泛的影响/商业影响包括用于多重免疫测定的增强技术，用于POC的更有效的血浆生成系统，以及用于定义对免疫的抗体应答的经证实的方法。 仅在美国，每年就有超过1000万人必须核实他们的免疫状况。目前的做法是由初级保健提供者提供可核实的免疫记录，或通过适当的抗体测试证明免疫力。为SBIR项目提出的POC免疫评估装置将为所有无法获得经核实的免疫记录的人提供快速、可靠和成本较低的解决方案。该设备避免了抗体滴度测试所需的费用和长时间的等待，目前抗体滴度测试是没有可验证记录的人的唯一选择。 该测试系统将提供改进的、快速的和廉价的测试方法，以及使用通用设备捕获、分析和存储结果的手段。

This Small Business Innovation Research (SBIR) Phase I project will create a multiplexed point-of-care (POC) testing platform for the assessment and verification of vaccination using whole blood samples. For the rapid assessment of immunization status, both accurate multiplexing and plasma separation from whole blood pose technical hurdles for POC test systems. Lateral flow immunoassays have been limited in achieving multiplexed results from whole blood samples. Plasma separation from blood in sufficient sample volumes, and interferences from neighboring immunoreaction, creates significant technical hurdles for development of an effective POC test for immunity. Moreover, an epitope-specific assessment of immunity has yet to be demonstrated in such a test. The objectives of this proposal will be to create a plasma-generating multiplexed epitope-specific test device for testing immunity to viral diseases. The Phase I project will establish optimum, non-interfering, peptide array configurations on appropriate nitrocellulose surfaces in line with a blood separation material. In parallel, the company will take advantage of epitope mapping technology. The elucidation of multiple vaccine-response epitopes, and the design and validation of peptide affinity-capture analogs to enable quantification of circulating vaccine-response antibodies, will be essential to creating an accurate serological test.The broader impact/commercial impact of this project includes an enhanced technology for multiplexed immunoassay, a more efficient plasma generation system for POC, and a demonstrated methodology for defining antibody responses to immunization. More than 10,000,000 people in the US alone must verify their immunization status each year. This is currently accomplished by providing a verifiable immunization record from a primary health care provider, or by demonstrating proof-of-immunity through appropriate antibody tests. The POC immunization assessment device proposed for this SBIR project will provide a rapid, reliable and lower cost solution for all of those who do not have access to verified immunization records. The devicde avoids the expense and long wait required for antibody titer tests, currently the only option for people without verifiable records. The test system will provide improved, rapid, and inexpensive test methodology as well as a means to capture, analyze, and store the results using common equipment.