Abstract
On-site severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) serological assays allow for timely in-field decisions to be made regarding patient status, also enabling population-wide screening to assist in controlling the coronavirus disease 2019 (COVID-19) pandemic. Here we propose a rapid microfluidic serological assay with two unique functions of nanointerstice filling and digitized flow control, which enable the fast/robust filling of the sample fluid as well as precise regulation of duration and volume of immune reaction. Developed microfluidic assay showed enhanced limit of detection, and 91.67% sensitivity and 100% specificity (n = 152) for clinical samples of SARS CoV-2 patients. The assay enables daily monitoring of IgM/IgG titers and patterns, which could be crucial parameters for convalescence from COVID-19 and provide important insight into how the immune system responds to SARS CoV-2. The developed on-site microfluidic assay presented the mean time for IgM and IgG seroconversions, indicating that these titers plateaued days after seroconversion. The mean duration from day 0 to PCR negativity was 19.4 days (median 20 d, IQR 16-21 d), with higher IgM/IgG titres being observed when PCR positive turns into negative. Simple monitoring of these titres promotes rapid on-site detection and comprehensive understanding of the immune response of COVID-19 patients.
Keywords: COVID-19; Immunoassay; Microfluidics; POCT; SARS-CoV-2.
【저자키워드】 COVID-19, SARS-CoV-2., Microfluidics, immunoassay, POCT, 【초록키워드】 SARS CoV-2, coronavirus disease, SARS-CoV-2, Coronavirus disease 2019, coronavirus, immune response, pandemic, immune system, severe acute respiratory syndrome Coronavirus, Microfluidics, immunoassay, clinical samples, sensitivity, specificity, Seroconversion, Serological assay, serological assays, IgM/IgG, Patient, limit of detection, POCT, convalescence, respiratory, patients, function, COVID-19 patients, IgM and IgG, Volume, acute respiratory syndrome, Regulation, daily monitoring, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, PCR positive, SARS CoV, PCR negativity, titre, immune reaction, parameter, simple, clinical sample, median, unique, promote, respond, turn, the mean, assist, Developed, IQR, 【제목키워드】 serological test, Quantitative,