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）：该提案的目的是开发一个统计的棕榈大小的血液计数器，用于监测全面的血液计数（CBC），并在紧急情况下使用3部分差异。血液计数的变化可能反映出严重恶化的医疗状况。例如，在感染或白血病爆炸危机期间，白细胞计数迅速上升。血细胞比容的值可能会迅速下降创伤，胃肠道出血和手术后恢复。在化学疗法和特发性血小板减少性紫癜期间，血小板值可能会显着下降。在这些情况下，必须对患者的血液计数进行密切和频繁的监测，无论是输血，血小板输血还是药物管理，都必须提供最佳护理和治疗。这些临床方案反映了巨大的市场需求。 2007年，进行了27亿美元的血液学检查。其中，估计其中25-35％的测试是STAT测试，理想情况下是在护理点上进行的。拟议的血液柜台样本从患者的血液中进行了指尖，并在患者的一侧实时分析了临床决策。这与当今的测量技术相反，后者需要台式工具和训练有素的技术人员。这一II期SBIR工作的中心假设是：可以利用微流体技术来开发一种仅需要血液针刺的掌上式血液计数器。提出的24个月II期努力利用了我们在微流体，敏感检测和精确测量方面的I期成就来开发手持紧急血液传感器的原型。开发这种设备需要检测和微流体的进步。具体目标1将利用我们的微流体技术评估连续细胞稀释ad ad红细胞裂解。特定的目标2将用于开发测量广泛的细胞参数所需的集成光学和电阻抗检测系统。特定的目标3将用于开发我们Stat血液计数器的手持式面包板原型，并在一组临床样本中验证其针对金标准的血液计数器的性能。第二阶段的成功将导致第三阶段的工作，其中将包括用于商业统计血液计数器产品的详细产品工程，FDA 510（k）批准的测试以及商业化。可以在各种设置中使用所得的产品，包括救护车，住院室，手术室，医疗办公室和资源饥饿的设置。