Ultra-sensitive assays using SQUID magnetic sensors

SBIR第二阶段计划的目标是在下一代仪器中展示一种新的磁检测平台技术，该仪器能够对各种分析物进行超灵敏均质分析。新型磁检测系统将利用高温（高tc） SQUID传感器的重大进展，能够对少量磁标签进行定量测量。我们将开发一种针对亚原子摩尔范围检测的原型仪器。虽然灵敏度是主要优势，但我们也将重点展示均匀格式能力和处理小体积分析物的能力，这两者对于高通量筛选都很重要。我们将使用已建立的检测技术对细胞因子进行磁免疫分析。我们还将研究仪器对DNA探针非常重要的领域的适用性。理论上，它的灵敏度是如此之高，有可能提供一种简单而有效的替代PCR或其他目标扩增系统的方法。这种检测技术平台的商业影响是巨大的，范围从药物发现的高通量筛选到临床诊断DNA探针市场。建议的商业应用：我们的目标是开发一种台式磁免疫测定检测器，以满足研究和临床实验室的需要，这些实验室需要高灵敏度，现有技术受成本，吞吐量，灵敏度或毒性的限制。虽然最初开发的仪器是针对一个相当大的研究市场，但这种新的免疫测定系统有潜力在更大的（全球50亿美元/年）商业临床市场的许多细分市场中竞争。此外，该技术的灵敏度可能最终使我们能够在不进行PCR扩增步骤的情况下进行DNA分析，并将找到重要的商业和研究应用。

The goal of the proposed SBIR Phase 2 program is to demonstrate a new magnetic detection platform technology in a next generation instrument that is capable of performing ultra-sensitive homogeneous assays for a wide range of analytes. The novel magnetic detection system will take advantage of major advances in high-temperature (high-Tc) SQUID sensors that enables the quantitative measurements of a small number of magnetic labels. We will develop a prototype instrument that is targeted at detection in the sub-attomolar range. While the sensitivity is a major strength, we will also focus on demonstrating a homogeneous format capability and an ability to work with small volumes of analyte, both of which are important for high throughput screening. We will perform head-to-head comparisons of magnetic immunoassays on cytokines with established detection techniques. We will additionally investigate the suitability of the instrumentation to the very important area of DNA probes. In theory, the sensitivity is so great that the potential exists to provide a simple and efficient alternative to PCR or other target amplifications systems. The commercial impact of this detection technology platform is enormous and ranges from high throughput screening for drug discovery to the clinical diagnostic DNA probe market. PROPOSED COMMERCIAL APPLICATIONS: Our goal is to develop a bench-top magnetic immunoassay detector to meet the needs of research and clinical laboratories where high sensitivity is required and existing techniques are limited by cost, throughput, sensitivity, or toxicity. While the initial instrument to be developed is targeted at a sizable research market, this new immunoassay system has potential to compete in many segments of the much larger ($5 billion/year world-wide) commercial clinical market. In addition the sensitivity of this technology may ultimately allow us to perform DNA analysis without performing a PCR amplification step and would find significant commercial and research application.