With the evolution of the COVID‐19 pandemic, there is now a need for point‐of‐care devices for the quantification of disease biomarkers toward disease severity assessment. Disease progression has been determined as a multifactor phenomenon and can be treated based on the host immune response within each individual. CoST is an electrochemical immunosensor point‐of‐care device that can determine disease severity through multiplex measurement and quantification of spike protein, nucleocapsid protein, D‐dimer, and IL‐2R from 100 μL of plasma samples within a few minutes. The limit of detection was found to be 3 ng/mL and 21 ng/mL for S and N proteins whereas for D‐dimer and IL‐2R it was 0.0006 ng/mL and 0.242 ng/mL, respectively. Cross‐reactivity of all the biomarkers was studied and it was found to be <20%. Inter and intra‐assay variability of the CoST sensor was less than <15% confirming its ability to detect the target biomarker in body fluids. In addition, this platform has also been tested to quantify all four biomarkers in 40 patient samples and to predict the severity index. A significant difference was observed between healthy and COVID‐19 samples with a p‐value of 0.0002 for D‐dimer and <0.0001 for other proteins confirming the ability of the COST sensor to be used as a point of care device to assess disease severity at clinical sites. This device platform can be modified to impact a wide range of disease indications where prognostic monitoring of the host response can be critical in modulating therapy.
Monitoring of plasma drug concentrations is required for effective and safe pharmacotherapies. Recent technical advances gave rise to various portable or wearable biosensors for rapid on-site monitoring. These devices are not yet popular owing to not only insufficient evaluation of accuracy on clinical samples and sensor-to-sensor variability but also the need for complicated costly fabrication processes. To address these bottlenecks, here, we describe a simple strategy based on boron-doped diamond (BDD) without any engineering modifications. As a test compound, we selected pazopanib, a molecular-targeting anticancer drug whose monitoring is recommended. When assaying rat plasma spiked with pazopanib, a sensing system constructed from a ~1 cm2 BDD plate chip detected concentrations in the clinically relevant range. The response was stable in a series of 60 measurements on the same chip, indicating excellent repeatability of the assay and high sustainability of the material. When plasma samples collected from orally treated healthy rats or patients with cancers were analysed with the system, the results overall matched the concentrations determined by liquid chromatography with mass spectrometry. Additionally, the reproducibility of BDD chip–based assays was tested. Finally, we constructed a portable system with a palm-sized sensor containing a BDD chip and demonstrated that the setup successfully quantifies the drug in plasma from ~40 µL of whole blood of a dosed rat within a short turnaround time: ~10 min. This approach with the ‘reusable’ sensor, which can also possibly detect other drug types, may accelerate point-of-testing assays and advance personalised medicine while reducing medical costs.
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