STAT Palm-Sized Blood Counter

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）。血液计数的变化可以反映病情的急剧恶化。例如，在感染或白血病爆发危机期间，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，无论是输血、输血小板还是给药，都必须密切和频繁地监测患者的血细胞计数，以提供最佳护理和治疗。这些临床情况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。其中，估计有25-35%的测试是STAT测试，理想情况下是在护理点进行。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。这与今天的测量技术形成鲜明对比，后者需要台式仪器和训练有素的技术人员。这项二期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。提议的为期24个月的第二阶段工作利用我们在微流体，敏感检测和精密测量方面的第一阶段成就来开发手持式应急血液传感器原型。开发这样的装置需要在检测和微流体方面取得进展。特异性目标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。Specific Aim 2将用于开发一种集成的光学和电阻抗检测系统，该系统用于测量广泛的细胞参数。Specific Aim 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与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，其中包括商业STAT血液计数器产品的详细产品工程，FDA 510(k)批准测试和商业化。由此产生的产品可以在广泛的环境中使用，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。

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. PUBLIC HEALTH RELEVANCE: 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 is designed to provide much needed medical information during critical emergencies.