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Biosens Bioelectron . Magnetofluidic immuno-PCR for point-of-care COVID-19 serological testing

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  • Biosens Bioelectron . Magnetofluidic immuno-PCR for point-of-care COVID-19 serological testing

    Biosens Bioelectron

    . 2021 Sep 23;195:113656.
    doi: 10.1016/j.bios.2021.113656. Online ahead of print.
    Magnetofluidic immuno-PCR for point-of-care COVID-19 serological testing

    Pengfei Zhang 1 , Liben Chen 2 , Jiumei Hu 2 , Alexander Y Trick 1 , Fan-En Chen 1 , Kuangwen Hsieh 2 , Yang Zhao 1 , Branch Coleman 3 , Kate Kruczynski 4 , Thomas R Pisanic 2nd 5 , Christopher D Heaney 4 , William A Clarke 3 , Tza-Huei Wang 6



    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.