STAT Palm-Sized Blood Counter

描述(由申请人提供)：本提案的目标是开发一种用于在紧急情况下监测全血细胞计数(CBC)的状态手掌大小的血细胞计数器(CBC)。血细胞计数的变化可能反映出急剧恶化的医疗条件。例如，在感染或白血病急变期间，白细胞计数可能会迅速上升。在创伤、胃肠道出血和术后恢复中，红细胞压积可能会迅速下降。化疗和特发性血小板减少性紫癜期间，血小板值可能会显著下降。在这些情况下，必须密切和频繁地监测患者的血细胞计数，以提供最好的护理和治疗，无论是输血、血小板输注还是给药。这些临床场景反映了巨大的市场需求。2007年，进行了27亿美元的血液学测试。在这些测试中，估计有25%-35%是统计测试，最理想的是在护理地点执行。拟议的血液计数器从患者身上采集一根血样，并在患者身边进行实时分析，以供急诊点临床决策。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。这项第二阶段SBIR工作的中心假设是：微流控技术可以用来开发一种集成的手掌大小的血液计数器，只需要针刺血液。拟议的为期24个月的第二阶段工作利用我们在微流体、灵敏检测和精密测量方面的第一阶段成就来开发手持式紧急血液传感器的原型。开发这样的设备需要检测和微流控技术的进步。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溶解。具体目标2将用于开发测量各种电池参数所需的集成光学和电阻抗检测系统。我们将利用特定目标3来开发我们的STAT血液计数器的手持式面包板原型，并通过一组临床样本验证其与黄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工作，其中将包括商业统计血液计数器产品的详细产品设计，FDA 510(K)批准的测试，以及商业化。产品可广泛用于各种环境，包括救护车、住院室、手术室、医务室和资源匮乏的环境。

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.