SBIR Phase I: A Wireless Portable Fully Electronic Hematology Analyzer for Complete Blood Count Analysis

该小型企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力是开发一种用于在家庭或小型临床环境中进行血液检测的新设备。该平台将完全电子化，便携式，低成本，并使用先进的人工智能技术。 这种拟议的分析仪以低得多的成本提供通常从昂贵的高端商业设备中获得的信息，从而能够针对许多不同的条件进行新的诊断和监测。此外，这里开发的超紧凑型模块将适用于全血细胞计数分析以外的广泛检测。这个小型企业创新研究（SBIR）第一阶段项目旨在构建和表征一种超紧凑型全电子血细胞仪，具有全塑料盒，能够量化全血细胞计数（CBC）测试中的关键细胞成分，包括：红细胞（RBC）、白色细胞（WBC）、血小板、血红蛋白（hgb）浓度和血细胞比容水平。将结合机器学习开发阻抗血细胞计数器，以区分RBC、WBC和血小板，同时估计少于15 ul血液的hgb和血细胞比容水平。主要目标是设计一种可以与阅读器一起工作的墨盒，同时以超低成本大批量制造。该研究将涉及制造和测试集成的微流体生物传感器，开发数据驱动的软件，使用阻抗细胞仪数据对血细胞类型进行准确分类，构建超紧凑的袖珍硬件和智能手机应用程序，最后，根据标准对原型准确性进行基准测试和测试。该奖项反映了NSF的法定使命，并通过使用基金会的学术价值和更广泛的影响评审标准。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to develop a new device for conducting blood tests at home or in smaller clinical settings. The platform will be fully electronic, portable, low-cost, and using advanced artificial intelligence techniques. This proposed analyzer provides information normally obtained from costly high-end commercial equipment at much lower cost, enabling new diagnosis and monitoring for many different conditions. Additionally, the ultra-compact modules developed here will be applicable to a broad range of assays beyond complete blood count analysis.This Small Business Innovation Research (SBIR) Phase I project seeks to build and characterize an ultra-compact all-electronic cytometer with a fully plastic cartridge capable of quantifying the key cellular components in a complete blood cell count (CBC) test including: red blood cells (RBC), white blood cells (WBC), platelets, hemoglobin (hgb) concentration, and hematocrit levels. An impedance cytometer will be developed in conjunction with machine learning to discriminate between RBCs, WBCs, and platelets, while estimating hgb and hematocrit levels with less than 15 ul of blood. The primary goal is to engineer a cartridge that can work with the reader while being manufacturable in high volume with ultra-low cost. The research will involve fabrication and testing an integrated microfluidic biosensor, developing data-driven software for accurate classification of blood cell types using impedance cytometry data, building ultra-compact pocket-sized hardware and a smartphone application, and finally benchmarking and testing of prototype accuracy against a standard.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.