Measurement of serum phosphate levels using a mobile sensor.

The measurement of serum phosphate concentration is crucial for patients with advanced chronic kidney disease (CKD) and those on maintenance dialysis, as abnormal phosphate levels may be associated with severe health risks. It is important to monitor serum phosphate levels on a regular basis in these patients; however, such measurements are generally limited to every 0.5-3 months, depending on the severity of CKD. This is due to the fact that serum phosphate measurements can only be performed at regular clinic visits, in addition to cost considerations. Here we present a portable and cost-effective point-of-care device capable of measuring serum phosphate levels using a single drop of blood (<60 µl). This is achieved by integrating a paper-based microfluidic platform with a custom-designed smartphone reader. This mobile sensor was tested on patients undergoing dialysis, where whole blood samples were acquired before starting the hemodialysis and during the three-hour treatment. This sampling during the hemodialysis, under patient consent, allowed us to test blood samples with a wide range of phosphate concentrations, and our results showed a strong correlation with the ground truth laboratory tests performed on the same patient samples (Pearson coefficient r = 0.95 and p < 0.001). Our 3D-printed smartphone attachment weighs about 400 g and costs less than 80 USD, whereas the material cost for the disposable test is <3.5 USD (under low volume manufacturing). This low-cost and easy-to-operate system can be used to measure serum phosphate levels at the point-of-care in about 45 min and can potentially be used on a daily basis by patients at home.

Quantitative particle agglutination assay for point-of-care testing using mobile holographic imaging and deep learning.

Particle agglutination assays are widely adopted immunological tests that are based on antigen-antibody interactions. Antibody-coated microscopic particles are mixed with a test sample that potentially contains the target antigen, as a result of which the particles form clusters, with a size that is a function of the antigen concentration and the reaction time. Here, we present a quantitative particle agglutination assay that combines mobile lens-free microscopy and deep learning for rapidly measuring the concentration of a target analyte; as its proof-of-concept, we demonstrate high-sensitivity C-reactive protein (hs-CRP) testing using human serum samples. A dual-channel capillary lateral flow device is designed to host the agglutination reaction using 4 µL of serum sample with a material cost of 1.79 cents per test. A mobile lens-free microscope records time-lapsed inline holograms of the lateral flow device, monitoring the agglutination process over 3 min. These captured holograms are processed, and at each frame the number and area of the particle clusters are automatically extracted and fed into shallow neural networks to predict the CRP concentration. 189 measurements using 88 unique patient serum samples were utilized to train, validate and blindly test our platform, which matched the corresponding ground truth concentrations in the hs-CRP range (0-10 µg mL-1) with an R2 value of 0.912. This computational sensing platform was also able to successfully differentiate very high CRP concentrations (e.g., >10-500 µg mL-1) from the hs-CRP range. This mobile, cost-effective and quantitative particle agglutination assay can be useful for various point-of-care sensing needs and global health related applications.