Microfluidic Cartridge for Point-of-Care Hematology Analysis

用于即时血液学分析的微流控盒

• 批准号: 10603090
• 负责人: Kelly Mabry
• 金额: $ 27.6万
• 依托单位: CELLIA SCIENCE, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-15 至 2024-01-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10603090
• 关键词: Acceleration; Algorithmic Analysis; Algorithms; Antipsychotic Agents; Area; Biological Assay; Blood; Blood Cell Count; Blood Cells; Blood Platelets; Blood Transfusion; Blood Viscosity; Blood specimen; CLIA certified; Calibration; Cells; Classification; Clinic; Color; Communicable Diseases; Complex; Development; Devices; Diagnosis; Erythrocytes; Evaluation; Future; Giemsa stain; Goals; Height; Hematocrit procedure; Hematological Disease; Hematology; Hour; Human Resources; Image; Imaging Device; Immune System Diseases; Label; Laboratories; Leukocytes; Licensing; Light; Maintenance; Manuals; Maps; Measurement; Methods; Microfluidics; Microscopy; Neutropenia; Nucleic Acids; Optics; Output; Patients; Performance; Pharmaceutical Preparations; Phase; Platelet Count measurement; Preparation; Property; Quartz; Reagent; Resource-limited setting; Sampling; Science; Slide; Source; Specific qualifier value; Techniques; Technology; Testing; Thrombocytopenia; Training; Work; cancer therapy; cell analyzer; cell type; cellular imaging; chemotherapy; classification algorithm; clinically relevant; cost; detection limit; diagnostic value; dietary; imager; imaging system; innovation; instrument; manufacture; monolayer; neutrophil; nucleic acid detection; operation; patient population; peripheral blood; point of care; point-of-care diagnostics; prototype; research and development; segmentation algorithm; transmission process; ultraviolet

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.

项目总结/摘要 中性粒细胞减少症和/或血小板减少症的评价需要5部分白色血细胞（WBC）分类， 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 实验室和依赖复杂的工作流程，涉及多种试剂，广泛的校准和维护， 并由训练有素的人员操作。周转时间延迟数小时或数天， 治疗，如化疗，抗精神病药物和输血。Cellia Science将 解决了对更快速的血细胞分类测试的需求，并开发了一种诊断中性粒细胞减少症的设备， 血小板减少症，适用于床旁或低资源环境。该设备将实现无标签深度 紫外成像结合微流控“血涂片”制备和细胞分类算法， 血细胞分类Cellia的深紫外图像是伪彩色的，看起来类似于Giemsa染色 图像，目前的黄金标准手动差异。然而，由于我们直接检测 细胞中的核酸，我们的图像本质上是具有亚细胞细节的定量核酸质谱图 和毫微微图灵敏度。在这个项目的第一阶段，我们将开发一个微流体样品盒原型， 验证其形成所需细胞单层的能力，并评价计数的准确度和精密度 使用带有我们的成像设备原型的墨盒进行。血液样本将涵盖临床相关的 红细胞压积水平范围，以验证不同血液粘度下的器械功能。准确度和精密度 将使用来自健康患者以及中性粒细胞减少症患者的样本对该器械进行评价， 血小板减少，以证明目标患者人群的性能可接受。成功 微流控样品盒的开发将证明可扩展的、鲁棒的样品的可行性。 用于即时血液学分析的检测盒。结合我们现有的原型成像设备， 分析算法，这将证明所提出的血液分析仪的可行性。