COVID severity test (CoST sensor)-An electrochemical immunosensing approach to stratify disease severity.

ABSTRACT

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.