Microfluidic Cartridge for Point-of-Care Hematology Analysis

项目摘要/摘要 对中性粒细胞减少和/或血小板减少的评估需要5部分白细胞(WBC)与 血小板计数。目前，能够进行这些测量的仪器必须在CLIA认证的 实验室并依赖复杂的工作流程，包括多种试剂、广泛的校准和维护、 并由训练有素的人员进行操作。几小时或几天的周转时间会延迟关键业务的管理 治疗，如化疗、抗精神病药物和输血。西莉亚科学公司将 满足对更快速的血细胞鉴别测试的需求，并开发一种设备来诊断中性粒细胞减少症和 适用于护理地点或低资源环境的血小板减少症。该设备将实现无标签的深度 UV成像结合微流控“血涂片”制备和细胞分类算法执行 血细胞分化。Cellia的深紫外光图像是伪彩色的，看起来类似于Giemsa染色 图像，当前手动差异化的黄金标准。但是，因为我们直接检测到 细胞中的核酸，我们的图像本质上是带有亚细胞细节的定量核酸质量图 还有飞秒脉冲敏感度。在这个项目的第一阶段，我们将开发一个微流控样品盒原型， 验证其形成所需细胞单层的能力，并评估计数的准确性和精密度 与我们的成像设备原型一起使用墨盒进行了测试。血液样本将跨越临床相关的 红细胞压积的范围，以验证设备在不同血液粘度下的功能。精确度和精密度 该设备将使用来自健康患者以及中性粒细胞减少症患者的样本进行评估。 血小板减少，以证明对目标患者人群的可接受表现。成功 微流控样品盒的开发将证明可伸缩、坚固的样品的可行性 用于护理点血液学分析的色谱盒。结合我们现有的原型成像设备和 分析算法，这将论证所提出的血细胞分析仪的可行性。

Project Summary/Abstract Evaluation for neutropenia and/or thrombocytopenia requires a 5-part white blood cell (WBC) differential with platelet count. Currently, instruments capable of these measurements must be operated in a CLIA-certified laboratory and rely on complex workflows involving multiple reagents, extensive calibration and maintenance, and operation by highly trained personnel. Turnaround times of hours or days delay administration of critical treatments, such as chemotherapy, anti-psychotic medications, and blood transfusions. Cellia Science will address the need for more rapid blood cell differential tests and develop a device to diagnose neutropenia and thrombocytopenia suitable for point-of-care or low-resource settings. This device will implement label-free deep UV imaging combined with microfluidic “blood smear” preparation and cell classification algorithms to perform blood cell differentials. Cellia’s deep UV images are pseudo-colorized and appear similar to Giemsa-stained images, the current gold standard for manual differentials. However, because we are directly detecting the nucleic acids in the cells, our images are inherently quantitative nucleic acid mass maps with subcellular detail and femtogram sensitivity. In Phase I of this project, we will develop a microfluidic sample cartridge prototype, verify its ability to form the desired cell monolayers, and evaluate the accuracy and precision of counts performed using the cartridge with our imaging device prototype. Blood samples will span the clinically relevant range of hematocrit levels to verify device functionality at varying blood viscosities. Accuracy and precision of the device will be evaluated with samples from healthy patients as well as from patients with neutropenia and thrombocytopenia to demonstrate acceptable performance for the target patient population. Successful development of the microfluidic sample cartridge will demonstrate the feasibility of a scalable, robust sample cartridge for point-of-care hematology analysis. Combined with our existing prototype imaging device and analysis algorithms, this will demonstrate the feasibility of the proposed hematology analyzer.