Silicon Photonic Blood Typing

硅光子血型分析

• 批准号: 9763988
• 负责人: Danielle Drury-Stewart
• 金额: $ 74.61万
• 依托单位: SIDX, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-15 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9763988
• 关键词: Anemia; Antibodies; Biological Assay; Biosensor; Blood; Blood Banks; Blood Group Antigens; Blood Tests; Blood Transfusion; Blood Volume; Blood donor; Blood specimen; Blood typing procedure; Chemistry; Childhood; Clinical; Critical Illness; Detection; Devices; Diagnostic; Emergency Situation; Equipment and supply inventories; Freedom; Funding; Future; Goals; Hemorrhage; Hospitals; Iatrogenesis; Improve Access; Individual; Intellectual Property; Laboratories; Legal patent; Life; Medical; Methods; Minor; Modernization; Modification; Patient Care; Patients; Performance; Phase; Printing; Reaction; Reader; Readiness; Reagent; Reproducibility; Resources; Risk; Sampling; Savings; Secure; Seeds; Silanes; Silicon; Small Business Innovation Research Grant; Speed; Streptavidin; Surface; Surface Properties; System; Technology; Testing; Time; Training; Transfusion; Transportation; Universities; Validation; Vascular blood supply; Washington; Work; assay development; base; biochip; blood group; blood product; commercialization; cost; ethnic minority population; experience; immunoreaction; improved; laboratory experience; microdevice; nanolitre; nanophotonic; off-patent; photonics; sensor; sound; transfusion medicine

SUMMARY Millions of blood samples are tested annually to establish blood type compatibility between blood donors and transfusion recipients. However, current testing methods are encumbered by the need for large blood samples, transportation to centralized laboratories, time to centrifuge and perform testing, specialized reagents, and technical training needs, placing a costly burden on the medical system. In particular, reduced blood sampling volumes are desirable to avoid exacerbating anemia in patients who may require transfusion, particularly pediatric and critically ill patients. Additionally, current test times create the need to maintain universal units to provide emergency transfusions when the blood type of the patient is not yet known, placing a strain on the blood supply. Thus, there is a need for smaller, faster, better, and cheaper blood group testing. Our proposed solution will perform blood group testing on a multiplexed, low-cost, and scalable silicon nanophotonic biochip. This technology has been demonstrated in proof-of-concept studies to detect A, B, and RhD (D) blood groups and anti-A and anti-B antibodies in small volume blood samples. SiDx, Inc. has licensed the core intellectual property, engaged an experienced FDA regulatory consultant, and secured seed funding to commercialize this technology. This application is seeking SBIR support for SiDx to advance this blood group testing technology towards readiness for FDA studies, with the future goal of FDA regulatory approval and commercialization of the product as a medical diagnostic. In this SBIR Fast Track Phase I/II application, we propose specific aims for each of the two Phases: In Phase I we propose one aim: to develop proof-of-concept assays to functionalize silicon photonic biosensors for the detection of blood groups C, E, and K. These blood groups are critical minor blood group antigens that can provoke severe, potentially life-threatening immune reactions and bring value in expanding the multiplexed blood group testing capabilities of the future product. In Phase II, we propose 2 aims: Aim II.1: to study surface functionalization conditions and optimize surface capture of streptavidin via covalent (silane) and non-covalent (physisorption) means on silicon photonic surfaces for blood group antigen and antibody assay validation; and Aim II.2: to multiplex ABO, D, C, E, and K blood group assays (and controls) on optimized functional surfaces using an inkjet arrayer and test assay performance. This aim will also assess samples that can challenge conventional testing methods in the clinical laboratory, such as weak D and mixed field reactions This silicon photonic blood typing chip holds the promise to modernize blood group testing with simple, fast, fully automated multiplexed blood group testing in small volume blood samples. We predict that, if successful, this product holds the potential to transform both blood group testing and transfusion medicine through small sample volume requirements, fully automated testing, and rapid time to results. This should reduce iatrogenic blood loss, delays in transfusion, minimize the use of universal units, and improve access in hospitals that currently have limited resources to support blood group testing capabilities.

总结 每年对数百万份血液样本进行检测，以确定献血者和 输血者然而，目前的测试方法受到需要大量血液样本的阻碍， 运送到中心实验室，离心分离和进行检测的时间，专用试剂，以及 技术培训需要，给医疗系统带来了昂贵的负担。特别是，减少血液采样 对于可能需要输血的患者， 儿科和重症患者。此外，当前的测试时间需要维护通用单元， 当病人的血型尚不清楚时，提供紧急输血，使血液紧张， 供应因此，需要更小、更快、更好和更便宜的血型测试。我们提出的解决方案 将在多路复用、低成本和可扩展的硅纳米光子生物芯片上进行血型测试。这 技术已在概念验证研究中得到证实，可检测A、B和RhD（D）血型， 小体积血液样本中的抗A和抗B抗体。SiDx公司已授权核心知识产权， 该公司聘请了一位经验丰富的FDA监管顾问，并获得了种子资金，将这项技术商业化。 该申请正在寻求对SiDx的SBIR支持，以将该血型检测技术推向 准备进行FDA研究，未来目标是获得FDA监管批准和产品商业化 作为医学诊断。在SBIR快速通道I/II阶段的应用中，我们为每个阶段提出了具体的目标， 两个阶段：在第一阶段，我们提出了一个目标：开发概念验证分析，以功能化硅光子晶体。 用于检测血型C、E和K的生物传感器。这些血型都是关键的次要血型 抗原，可以引起严重的，可能危及生命的免疫反应，并带来价值，扩大 未来产品的多重血型检测能力。在第二阶段，我们提出两个目标：目标II.1： 研究了链霉亲和素表面功能化条件，优化了链霉亲和素通过共价（硅烷）和 用于血型抗原和抗体测定的硅光子表面上的非共价（物理吸附）方法 目标II.2：在优化的基础上进行ABO、D、C、E和K血型检测（和质控品）的多重检测 使用喷墨阵列器对功能表面进行测试并测试分析性能。这一目标还将评估样本， 可挑战临床实验室的常规检测方法，如弱D和混合野反应 这种硅光子血型芯片有望通过简单，快速，全面的 在小体积血液样本中进行自动化多重血型检测。我们预测，如果成功， 该产品具有通过小样本改变血型检测和输血医学的潜力 批量要求、全自动测试和快速获得结果。这应该可以减少医源性失血， 延迟输血，尽量减少使用通用单位，并改善目前有 支持血型检测能力的资源有限。