Abstract

COVID-19, a disease resulting from the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), has caused more than 287 million infections and 5.5 million deaths worldwide. To mitigate the spread of the virus, highly specific, selective, and rapid Point of Care (POC) diagnostics are required to diagnose COVID-19 at all stages of infection. Here, we have developed a rapid, lightweight, portable, sensitive, and flexible paper-based microfluidic platform for singleplex and multiplex detection of biomarkers (antibodies and antigenic viral proteins) for COVID-19. Our singleplex platform, which individually tests for the SARS-CoV-2 Spike Protein (SP) and Nucleocapsid Protein (NP), demonstrates high sensitivity in the 100 pg/mL limit of detection range with a detection time of 5 minutes. In addition, our platform demonstrates high specificity to the SARS-CoV-2 SP when challenged in the presence of other coronavirus and pathogenic viruses. The detection capability for the SARS-CoV-2 SP in various specimen types (saliva, nasal fluid, blood, and urine) was also examined in this platform. As proof of concept, our platform was also evaluated for multiplex detection of antibodies against the SARS-CoV-2 SP (IgM and IgG) and the SP viral antigen in a single device. The platform demonstrates the capability for rapid multiplexing within 10 minutes.

Keywords: COVID-19; Paper-based test; Point-of-care diagnostics; Immunoassay