SBIR Phase II: Biosensor for Rapid Whole Blood Assays using Magnetic Labels and Giant Magnetoresistive Sensors

这一小型企业创新研究(SBIR)第二阶段项目利用全血化验促进了兽医和安全/国防市场诊断研究的总体状况。该第二阶段项目将开发(1)用于快速检测原型的自动化开放检测开发平台；(2)用于犬免疫评估和犬甲状腺检测(T4)的全血检测；以及(3)多路复用的犬全血检测。该方法使用磁珠标记捕获到受体图案微芯片上的生物分子，该芯片包含嵌入的磁性微传感器阵列。磁性微传感器是显示巨磁电阻(GMR)的线状结构。当与受控的流体力识别相结合时--这是一项极大地减少不需要的背景信号的创新--实现了对生物分子的高灵敏度和高特异性的快速识别。已经开发了一种用于免疫分析和核酸分析的原型系统，免疫分析(1 ng/mL)在不到10分钟内饱和，在10fm处检测到未修饰的DNA在不到20分钟内。海鹰公司正在开发一种多用途、多用途的仪器和相关的一次性墨盒，以应对兽医面临的临床和财务挑战。这一技术平台为兽医提供了比现有产品更优越的性能(更快、更准确、更容易使用)和更大的盈利能力。最初，该平台将包括两个应用程序的墨盒：(1)个性化免疫评估和(2)疾病诊断，两者都是专门针对狗和猫的。该系统提供了一种诊所内、快速周转、经济高效和准确的动物免疫系统测试，以确定当时需要接种什么疫苗增强剂(如果有)。这为兽医提供了三个主要好处：(1)提高护理质量--仅在需要时为每只动物量身定做复种；(2)由于复种方案的变化而产生额外或替代收入；以及(3)取代每年复种作为客户遵守安排体检办公室访问的动力。

This Small Business Innovation Research (SBIR) Phase II project advances the general state of diagnostics research in the veterinary and security/defense markets using whole-blood assays. This Phase II project will develop (1) an automated Open Assay Development Platform for rapid assay prototyping; (2) whole blood assays for canine immunity assessment and canine thyroid test (T4); and, (3) multiplexed, canine whole blood assays. The approach uses magnetic beads to label biomolecules captured onto a receptor-patterned microchip that contains an embedded array of magnetic microsensors. The magnetic microsensors are wire-like structures that display giant magnetoresistance (GMR). When coupled with controlled fluidic force discrimination - an innovation that greatly reduces unwanted background signal - rapid identification of biomolecules with high sensitivity and specificity is achieved. A prototype system has been developed for both immunoassays and nucleic acid assays, with immunoassays (1 ng/mL) saturating in less than 10 minutes and unmodified DNA detected at 10fm in less than 20 minutes. Seahawk is responding to the clinical and financial challenges veterinarians face by developing a multi-use, multiplexed instrument and associated disposable cartridges. This technology platform offers veterinarians superior performance (faster, more accurate, easier to use) and greater profitability than existing products. Initially, the platform will include cartridges for two applications: (1) individualized immunity assessment and (2) disease diagnostics, both specifically for dogs and cats. The system provides an in-clinic, quick turnaround, cost-effective and accurate test of an animal's immune system to determine what, if any, vaccine boosters need to be administered at that time. This provides the veterinarians with three key benefits: (1) improving the quality of care - providing revaccinations only when needed and tailored to each animal; (2) generating additional or replacement revenue due to changes in revaccination protocols; and, (3) replacing annual revaccinations as the impetus for customer compliance with scheduling office visits for physical exams.