SBIR Phase I: Quantum Diamond Sensors with Rapid Sample Transfer for High-Throughput Magnetic Bioassays

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是使量子磁性生物分析技术用于医疗诊断、精确健康和护理点患者护理所需的高样本测试吞吐量。对低浓度生物标志物的超灵敏检测，为改善临床决策和改善患者健康提供了新的诊断能力，其中许多目前是现有技术无法检测到的。现有的高灵敏度诊断仪器使用非常复杂，价格昂贵，需要漫长的样本处理步骤--所有这些都增加了卫生保健成本。利用NV钻石量子传感器开发了一种高灵敏度和低样品处理相结合的新型磁基分析方法。磁性分析平台可以更快地提供与当前生物标记物分析相同的结果，并且成本显著降低。样品处理大大减少，结合磁性标签的直接检测，将提供快速测试结果，这是护理点诊断的关键组件。这种方法的一个剩余挑战是快速和重复地将生物测定样本送到传感器--这是本项目要解决的一个挑战。这个小型企业创新研究(SBIR)第一阶段项目将开发一种快速样品传输机制，以提高使用量子磁性传感器的生物分析的样品吞吐量。量子传感能够以与生物样本兼容的方式实现革命性的磁敏感度和空间分辨率。然而，样品必须靠近钻石传感器进行分析，样品之间的转移必须在几秒钟内进行，同时保持传感性能。在本项目中设计和制造的原型样品传输系统将实施一种创新的新工艺，以在化验样品之间快速转换。硬件将紧凑，需要很少的电力，并且可以低成本制造。在第一阶段开发的原型样品传输硬件将为基于量子传感器的生物分析设备的后续工程奠定基础，最初将应用于仅用于研究(RUO)部门，随后将应用于临床体外诊断。这一进展将弥合量子磁传感能力与临床应用的样本吞吐量需求之间的差距。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to enable the high sample testing throughput necessary for quantum magnetic bioassay technology to be used for medical diagnostics, precision health and point of care patient care. Ultrasensitive detection of low-concentration biomarkers, many of which are currently undetectable by existing technology, offers new diagnostic capability for improved clinical decisions and better patient health. Existing high-sensitivity diagnostic instruments are very complex to use, expensive and require lengthy sample processing steps - all of which increase health care costs. A new class of magnetic-based assays combining high sensitivity and low sample processing using NV diamond quantum sensors has been developed. Magnetic assay platforms can deliver equivalent results to current biomarker assays faster and at significantly lower cost. A dramatic reduction in sample processing, combined with direct detection of magnetic tags, will provide rapid test results, a critical component for point of care diagnostics. A remaining challenge for this approach is delivering bioassay samples to the sensor quickly and repeatedly - a challenge to be addressed in this project. This Small Business Innovation Research (SBIR) Phase I project will develop a rapid sample transfer mechanism to enhance the sample throughput of bioassays using a quantum magnetic sensor. Quantum sensing enables revolutionary magnetic sensitivity and spatial resolution in a modality compatible with biological samples. However, the sample must be delivered close to the diamond sensor for analysis, and transfer between samples must occur in seconds, all while maintaining sensing performance. Prototype sample transfer systems designed and fabricated in this project will implement an innovative new process to rapidly transition between assay samples. The hardware will be compact, require little power, and be manufacturable at low cost. Prototype sample transfer hardware developed in Phase I will form the basis for subsequent engineering of quantum sensor based bioassay devices, with initial applications to the research use only (RUO) sector, and later to clinical in vitro diagnostics. This advance will bridge the gap between the capabilities of quantum magnetic sensing and the sample throughput needs of clinical applications.