STAT Palm-Sized Blood Counter

STAT 掌上型血液计数器

• 批准号: 8495402
• 负责人: Eugene Yan-ho Chan
• 金额: $ 48.63万
• 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 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8495402
• 关键词: Ambulances; Behavior; Blast Phase; Blood; Blood Platelets; Blood Tests; Blood Transfusion; Blood capillaries; Blood specimen; Caring; Cell Volumes; Cells; Cessation of life; Clinical; Complete Blood Count; Coulter counter; Custom; Cytolysis; Detection; Devices; Drops; Electrodes; Emergency Situation; Engineering; Equation; Erythrocytes; FDA approved; Fluorescence; Goals; Gold; Head; Hematocrit procedure; Hematology; Hemoglobin; Hemorrhage; Idiopathic Thrombocytopenic Purpura; Individual; Infection; Inpatients; Institutional Review Boards; Laboratories; Lasers; Lead; Length; Leukocytes; Life; Liquid substance; Lymphocyte; Manuals; Marketing; Measurement; Measures; Medical; Methods; Microfluidic Microchips; Microfluidics; Modality; Monitor; Operating Rooms; Optics; Patients; Performance; Pharmaceutical Preparations; Phase; Platelet Transfusion; Procedures; Public Health; Pump; Reagent; Recovery; Research; Resources; Respiratory Diaphragm; Robotics; Saline; Sampling; Series; Side; Small Business Innovation Research Grant; Spectrophotometry; Staging; Steel; System; Technology; Testing; Time; Training; Trauma; Variant; Venipunctures; Vortex Mixer; White Blood Cell Count procedure; Work; analog; capillary; chemotherapy; clinical decision-making; commercialization; cost; design; detector; electric impedance; gastrointestinal; granulocyte; instrument; miniaturize; monocyte; point of care; portability; prototype; rapid diagnosis; research study; 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) with 3-part differential 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 a 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 blood counts is a must to deliver the best care and treatment, whether it be blood transfusions, platelet transfusions, or drug administrations. These clinical scenarios reflect a significant market need. In 2007, $2.7 billion of hematology tests were performed. Of these, an estimated 25-35% of these tests were STAT tests, which are ideally performed at the point-of-care. 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 measurement technologies, which require a benchtop instrument and a trained technician. The central hypothesis for this Phase II 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 24-month Phase II effort leverages our Phase I accomplishments in microfluidics, sensitive detection, and precision measurements to develop a prototype handheld emergency blood sensor. Advances in detection and microfluidics are required to develop such a device. Specific Aim 1 will utilize our microfluidics technology to assess serial cell dilution ad red cell lysis. Specific Aim 2 will be utilized to develop an integrated optical and electrical impedance detection system required for measurement of a wide range of cell parameters. Specific Aim 3 will be utilized to develop a handheld, breadboard prototype of our STAT blood counter and validate its performance against a gold-standard blood counter across a set of clinical samples. Success in Phase II will lead to a Phase III effort which will include detailed product engineering for a commercial STAT blood counter product, tests for FDA 510(k) approval, and commercialization. The resulting product can be utilized in a wide- range of settings including ambulances, inpatient rooms, operating rooms, medical offices, and resource- starved settings.

描述（由申请人提供）：本提案的目标是开发一种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）和三部分分类。血细胞计数的变化可以反映急性恶化的医疗条件。例如，白色血细胞计数迅速上升可能发生在感染或白血病急变期间。在创伤、胃肠道出血和术后恢复期，红细胞压积值可能迅速下降。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血细胞计数是提供最佳护理和治疗的必要条件，无论是输血、血小板输注还是药物管理。这些临床场景反映了巨大的市场需求。2007年，进行了价值27亿美元的血液学检查。其中，估计25-35%的这些测试是STAT测试，理想情况下在护理点进行。所提出的血液计数器从患者的手指针刺血液中取样，并在患者侧实时分析血液，以用于紧急临床决策。这与当今的测量技术形成了鲜明对比，后者需要台式仪器和训练有素的技术人员。SBIR第二阶段工作的核心假设是：可以利用微流体技术开发一种集成的手掌大小的血液计数器，只需要一个针刺的血液。拟议的为期24个月的第二阶段工作利用了我们在微流体、灵敏检测和精确测量方面的第一阶段成就，开发了一种原型手持式应急血液传感器。需要在检测和微流体方面取得进展来开发这样的设备。具体目标1将利用我们的微流体技术来评估连续细胞稀释和红细胞裂解。具体目标2将被用来开发一个集成的光学和电阻抗检测系统所需的测量范围广泛的细胞参数。Specific Aim 3将用于开发STAT血液计数器的手持式试验板原型，并在一组临床样本中验证其相对于金标准血液计数器的性能。第二阶段的成功将导致第三阶段的努力，其中将包括商业STAT血液计数器产品的详细产品工程，FDA 510（k）批准和商业化的测试。所得到的产品可用于广泛的环境，包括救护车、住院室、手术室、医务室和资源匮乏的环境。