Abstract
Serological tests play an important role in the fight against Coronavirus Disease 2019 (COVID-19), including monitoring the dynamic immune response after vaccination, identifying past infection and determining community infection rate. Conventional methods for serological testing, such as enzyme-linked immunosorbent assays and chemiluminescence immunoassays, provide reliable and sensitive antibody detection but require sophisticated laboratory infrastructure and/or lengthy assay time. Conversely, lateral flow immunoassays are suitable for rapid point-of-care tests but have limited sensitivity. Here, we describe the development of a rapid and sensitive magnetofluidic immuno-PCR platform that can address the current gap in point-of-care serological testing for COVID-19. Our magnetofluidic immuno-PCR platform automates a magnetic bead-based, single-binding, and one-wash immuno-PCR assay in a palm-sized magnetofluidic device and delivers results in ∼30 min. In the device, a programmable magnetic arm attracts and transports magnetically-captured antibodies through assay reagents pre-loaded in a companion plastic cartridge, and a miniaturized thermocycler and a fluorescence detector perform immuno-PCR to detect the antibodies. We evaluated our magnetofluidic immuno-PCR with 108 clinical serum/plasma samples and achieved 93.8% (45/48) sensitivity and 98.3% (59/60) specificity, demonstrating its potential as a rapid and sensitive point-of-care serological test for COVID-19.
Keywords: COVID-19; Immuno-PCR; Magnetofluidic device; Point-of-care; Serological testing.
【저자키워드】 COVID-19, point-of-care, serological testing., Immuno-PCR, Magnetofluidic device, 【초록키워드】 coronavirus disease, serological test, Coronavirus disease 2019, immune response, vaccination, antibody, Infection, Coronavirus disease 2019 (COVID-19), Laboratory, immunoassays, point-of-care, lateral flow immunoassay, sensitivity, specificity, enzyme-linked immunosorbent assay, Antibody detection, Serological tests, Serological testing, enzyme-linked immunosorbent assays, Community, infection rate, point-of-care test, Lateral flow immunoassays, chemiluminescence, platform, Device, community infection, Transport, enzyme, plasma samples, serum/plasma, reagent, magnetic bead, cartridge, thermocycler, detect, evaluated, Conventional, the antibodies,