Acoustofluidic-based microscopic examination for automated and point-of-care urinalysis

Urinalysis is a heavily used diagnostic test in clinical laboratories; however, it is chronically held back by urine sediment microscopic examination. Current instruments are bulky and expensive to be widely adopted, making microscopic examination a procedure that still relies on manual operations and requires large time and labor costs. To improve the efficacy and automation of urinalysis, this study develops an acoustofluidic-based microscopic examination system. The system utilizes the combination of acoustofluidic manipulation and a passive hydrodynamic mechanism, and thus achieves a high throughput (1000 μL min^-1) and a high concentration factor (95.2 ± 2.1 fold) simultaneously, fulfilling the demands for urine examination. The concentrated urine sample is automatically dispensed into a hemocytometer chamber and the images are then analyzed using a machine learning algorithm. The whole process is completed within 3 minutes with detection accuracies of erythrocytes and leukocytes of 94.6 ± 3.5% and 95.1 ± 1.8%, respectively. The examination outcome of urine samples from 50 volunteers by this device shows a correlation coefficient of 0.96 compared to manual microscopic examination. Our system offers a promising tool for automated urine microscopic examination, thus it has potential to save a large amount of time and labor in clinical laboratories, as well as to promote point-of-care urine testing applications in and beyond hospitals.