Microfluidic Cartridge for Point-of-Care Hematology Analysis

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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.