STAT Palm-Sized Blood Counter

STAT 掌上型血液计数器

• 批准号: 7801307
• 负责人: Eugene Yan-ho Chan
• 金额: $ 10万
• 依托单位: DNA MEDICINE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-02-09 至 2011-02-08
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7801307
• 关键词: Ambulances; Area; Biological Assay; Blast Phase; Blood; Blood Cells; Blood Platelets; Blood Volume; Blood specimen; Caring; Cell Count; Cells; Cessation of life; Collection; Complete Blood Count; Coulter counter; DNA; Data; Data Analyses; Detection; Development; Devices; Dimensions; Drops; Elements; Emergency Situation; Flow Cytometry; Fluorescence; Fluorescent Dyes; Generations; Goals; Handedness; Hematocrit procedure; Hematology; Hemorrhage; Human; Idiopathic Thrombocytopenic Purpura; Infection; Inpatients; Institute of Medicine (U.S.); Label; Lasers; Lead; Left; Length; Leukocytes; Life; Linear Regressions; Manuals; Measurement; Measures; Mechanics; Medical; Methodology; Methods; Microfluidic Microchips; Microfluidics; Microspheres; Mission; Modality; Monitor; Moon; Operating Rooms; Patients; Patients' Rooms; Performance; Persons; Pharmaceutical Preparations; Phase; Physiologic pulse; Planet Mars; Platelet Transfusion; Procedures; Process; Public Health; Pump; Rank-Sum Tests; Recovery; Relative (related person); Reproducibility; Research; Resources; Saline; Sampling; Side; Small Business Innovation Research Grant; Solutions; Source; Space Flight; Staining method; Stains; Syringes; System; Techniques; Technology; Testing; Time; Training; Transfusion; Trauma; United States National Aeronautics and Space Administration; Variant; Venipunctures; Venous; White Blood Cell Count procedure; Whole Blood; Work; base; chemotherapy; clinical decision-making; commercialization; design; gastrointestinal; instrument; light scattering; mean corpuscular volume observed; miniaturize; novel strategies; point of care; pressure; programs; prototype; public health relevance; rapid diagnosis; sensor; success

DESCRIPTION (provided by applicant): The goal of this proposal is to develop a STAT palm-sized blood counter for monitoring complete blood counts (CBC) during emergencies. Changes in blood counts can reflect acutely worsening medical conditions. For instance, a rapidly rising white blood cell count may occur during infections or leukemic blast crises. Hematocrit values may rapidly decline in traumas, gastrointestinal bleeds, and post-procedure recoveries. Platelet values may drop significantly during chemotherapy and idiopathic thrombocytopenic purpura. During these situations, close and frequent monitoring of a patient's CBC is a must to deliver the best care and treatment, whether it be blood transfusions, platelet transfusions, or drug administrations. The proposed blood counter samples a fingerstick of blood from the patient and analyzes it in real-time at the patient's side for point-of-emergency clinical decision making. This is in contrast to today's CBC measurement technologies, which require a benchtop instrument and a trained technician. The central hypothesis for this Phase I-III SBIR effort is this: microfluidic technology can be utilized to develop an integrated palm-sized blood counter that requires only a pinprick of blood. The proposed 12-month $100,000 Phase I research is based on work at the DNA Medicine Institute that includes developments in flow-focusing, detection, micromixing, and integration. For each of these areas, we have conceived or discovered novel approaches that can potentially augment accuracy, increase integration, and diminish the size of our blood counter. These miniaturized advances will be explored in our Specific Aims. Specific Aim 1 will identify the optimal flow-focusing and detection format for measurement of cell counts and volume. Specific Aim 2 will characterize prototype low Reynolds number micromixers with respect to mixing efficiency, functional Re, and blood compatibility. Specific Aim 3 will assess the performance of our prototype integrated microfluidic blood counter in measuring hematocrits relative to a predicate method. Successful completion of Phase I will support our core hypothesis and lead to a Phase II effort that will be utilized for developing a palm-sized prototype that is capable of bringing full hematology capabilities, a complete CBC and 5-part differential, to point-of-emergency situations. Phase III will comprise of development, FDA approvals, and commercialization. The resulting product would be applicable for emergencies in a wide-range of settings including ambulances, inpatient rooms, operating rooms, medical offices, and resource-starved settings. PUBLIC HEALTH RELEVANCE: NARRATIVE This research is relevant to public health because rapid diagnosis of blood counts can be the difference between life and death. The palm-sized blood counter product is designed to provide much needed medical information during critical emergencies.

描述（由申请人提供）：本提案的目标是开发一个STAT手掌大小的血液计数器，用于在紧急情况下监测全血细胞计数（CBC）。血液计数的变化可以反映病情的急剧恶化。例如，在感染或白血病细胞危象期间，白细胞计数可能迅速上升。在创伤、胃肠道出血和术后恢复时，红细胞压积值可能迅速下降。在化疗和特发性血小板减少性紫癜期间，血小板值可能显著下降。在这些情况下，密切和频繁地监测患者的CBC是提供最佳护理和治疗的必要条件，无论是输血、输血小板还是给药。所提出的血液计数器从患者身上采集一根手指的血液，并在患者身边实时分析，以便在紧急情况下做出临床决策。这与今天的CBC测量技术形成对比，后者需要台式仪器和训练有素的技术人员。这项I-III期SBIR工作的中心假设是：微流体技术可以用来开发一个集成的手掌大小的血液计数器，只需要一针血。拟议的12个月10万美元的第一阶段研究是基于DNA医学研究所的工作，包括流动聚焦、检测、微混合和集成的发展。对于这些领域，我们已经构思或发现了新的方法，可以潜在地提高准确性，增加整合，并缩小我们的血液计数器的大小。这些微小的进步将在我们的具体目标中探讨。特异性目标1将确定用于测量细胞计数和体积的最佳流动聚焦和检测格式。具体目标2将在混合效率、功能Re和血液相容性方面描述原型低雷诺数微混合器。具体目标3将评估我们的原型集成微流体血液计数器相对于谓词方法测量红细胞比容的性能。第一阶段的成功完成将支持我们的核心假设，并导致第二阶段的努力，该阶段将用于开发手掌大小的原型，能够为紧急情况提供完整的血液学功能，完整的全血细胞计数和5部分差分。第三阶段将包括开发、FDA批准和商业化。由此产生的产品将适用于各种紧急情况，包括救护车、住院病房、手术室、医疗办公室和资源匮乏的环境。