Microfluidic neutrophil counter for at-home use by chemotherapy patients

描述（由申请人提供）：本提案描述了一种快速计数患者血液样本中中性粒细胞的新方法。中性粒细胞增多症是化疗的一种常见副作用，其特征是作为抵抗感染的主要防御的中性粒细胞数量异常低。如果不及时就医，中性粒细胞减少症可能会危及生命。由于大多数肿瘤患者（美国每年约有100万）在门诊接受治疗，因此必须密切和频繁监测中性粒细胞的数量，以便在中性粒细胞减少症和相关感染的情况下及时治疗。此外，患有中性粒细胞减少症的接受抗增殖化疗的患者对医院（医院）感染特别敏感，每年导致99，000人死亡。因此，考虑到癌症患者的利益以及我们的医疗保健系统的成本和效率，在患者住所进行自我管理的中性粒细胞测试的能力特别重要和有吸引力。今天的全血细胞计数设备是为中央医疗机构设计的。它们非常昂贵，而且过于复杂，患者无法操作。即使是简单的血液检测设备的即时护理应用程序的目的是在医生的办公室和不适合病人管理的测试在家里使用。为了解决这一重要的未满足的需求，我们提出了一个独特的和创新的设备，患者管理的中性粒细胞测试在家里。我们的中性粒细胞计数装置利用了流经微流体通道时特别表现出的细胞特性。最近的出版物的支持下，细胞大小和变形能力的组合信息可以确定流动的细胞在微流体通道中的平衡位置，由于基本的流体动力学特性。我们发明了一种空时编码技术来编码每个移动细胞的前向散射信号。通过对信号进行解码，我们获得了每个细胞的速度和位置，精度非常高（0.1 μ m）。由于细胞的位置 微流体通道与细胞体积和变形性直接相关，我们已经发现了一种对白色血细胞，特别是嗜中性粒细胞进行分类的创新方法。我们的设备和分析方法具有以下突出特点：（1）它是微创的，只需要5微升的血液（类似于典型的血糖测试）;（2）简单的样品 制备和测试程序可由未经医学培训的人员执行;（3）易于理解并符合医学标准的准确测试结果;（4）低成本;以及（5）高便携性。因此，我们设想该设备的成功开发和商业化将为癌症患者带来巨大的好处，因为该设备可以大大降低医院感染的风险，降低医疗费用，由于密切监测中性粒细胞减少症而改善化疗期间的结果，并最大限度地减少不必要的医院和急诊室就诊的不便和痛苦。

DESCRIPTION (provided by applicant): This proposal describes a novel method for rapidly counting neutrophils in a patient's blood sample. Neutropenia, characterized by an abnormally low number of neutrophils that serve as the primary defense against infections, is a common side effect of chemotherapy. Without prompt medical attention, the condition of neutropenia may become life threatening. Since the majority of oncology patients (about 1 million each year in the US) are treated on an outpatient basis, the number of neutrophils must be closely and frequently monitored to allow timely treatment in the event of neutropenia and associated infections. Furthermore, patients undergoing antiproliferative chemotherapy with neutropenia are particularly sensitive to nosocomial (hospital) infections, causing 99,000 deaths each year. Therefore, in consideration of the interest of cancer patients, as well as the cost and efficiency of our healthcare system, the ability for self-administered neutrophil test at the patient's residence is particularly important and attractive. Today's complete blood count devices have been designed for central medical facilities. They are very expensive and too complicated to operate by patients. Even the simper blood test devices for point-of-care applications are designed for use in physician's office and unsuitable for patient-administered testing at home. To address this important unmet need, we propose a unique and innovative device for patient-administered neutrophil testing at home. Our neutrophil counting device takes advantage of cellular properties manifested specifically when flowing through microfluidic channels. Supported by recent publications, the combined information of cell size and deformability can determine the equilibrium positions of flowing cells in a microfluidic channel due to fundamental fluidic dynamic properties. We invented a space-time coding technique to encode the forward scattering signal of each travelling cell. By decoding the signal, we obtain the velocity and position of each individual cell with a very high accuracy (0.1 um). Since the cell position within a microfluidic channel is directly related to the cell volume and deformability, we have found an innovative method to classify white blood cells, particularly neutrophils. Our device and analysis method possesses the following salient features: (1) it is minimally invasive, requiring only 5 microliters of blood (a similar amount to a typical blood glucose test); (2) straightforward sample preparation and test procedures that can be performed by persons without medical training; (3) accurate test results that are easy to understand and compliant to medical standards; (4) low cost; and (5) high portability. We therefore envision that the successful development and commercialization of the device will bring tremendous benefits to cancer patients because the device can greatly reduce the risk of hospital infection, cut down healthcare costs, improve outcomes during chemotherapy due to close monitoring of neutropenia, and minimize the inconvenience and pain for unnecessary hospital and emergency room visits.