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

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是开发一种新的设备，用于在家庭或较小的临床环境中进行血液测试。该平台将完全电子化、便携、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获得的信息，从而能够对许多不同的情况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除完整的血液计数分析之外的广泛分析。这一小型企业创新研究(SBIR)第一阶段项目旨在构建并表征一种超紧凑型全电子细胞仪，其带有全塑料墨盒，能够量化完整血细胞计数(CBC)测试中的关键细胞成分，包括：红细胞(RBC)、白细胞(WBC)、血小板、血红蛋白(HGB)浓度和红细胞压积水平。阻抗细胞仪将与机器学习一起开发，以区分红细胞、白细胞和血小板，同时在血液小于15微升的情况下估计HGB和红细胞压积水平。主要目标是设计一种能够与读取器一起工作的墨盒，同时可以以超低成本大批量制造。这项研究将涉及制造和测试集成微流控生物传感器，开发数据驱动软件，使用阻抗细胞仪数据准确分类血细胞类型，构建超紧凑型袖珍硬件和智能手机应用程序，最后对照标准对原型的准确性进行基准测试。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

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.