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生物测定技术所需的高样品测试吞吐量能够用于医疗诊断，精确健康和护理点患者护理。低浓度生物标志物的超灵敏检测，其中许多目前无法通过现有技术检测，为改善临床决策和改善患者健康提供了新的诊断能力。现有的高灵敏度诊断仪器使用起来非常复杂，价格昂贵，需要漫长的样品处理步骤-所有这些都增加了医疗保健成本。已经开发了一类新的基于磁性的分析，其结合了使用NV金刚石量子传感器的高灵敏度和低样品处理。磁性测定平台可以更快地提供与当前生物标志物测定相当的结果，并且成本显著降低。样品处理的大幅减少，加上磁标签的直接检测，将提供快速的测试结果，这是护理点诊断的关键组成部分。这种方法的另一个挑战是快速和重复地将生物测定样品输送到传感器-这是本项目要解决的挑战。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转移机制，以提高使用量子磁传感器的生物测定的样品吞吐量。量子感测能够以与生物样品兼容的方式实现革命性的磁灵敏度和空间分辨率。然而，样品必须靠近金刚石传感器进行分析，样品之间的转移必须在几秒钟内发生，同时保持传感性能。在这个项目中设计和制造的原型样品转移系统将实现一个创新的新过程，以快速转换检测样品。硬件将是紧凑的，需要很少的功率，并且可以以低成本制造。在第一阶段开发的原型样品转移硬件将成为基于量子传感器的生物测定设备的后续工程的基础，最初应用于研究用途（RUO）部门，后来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.