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  • Point-of-care test system f...
    Peng, Tao; Sui, Zhiwei; Huang, Zhenghui; Xie, Jie; Wen, Kai; Zhang, Yongzhuo; Huang, Wenfeng; Mi, Wei; Peng, Ke; Dai, Xinhua; Fang, Xiang

    Sensors and actuators. B, Chemical, 03/2021, Volume: 331
    Journal Article

    Display omitted •A POCT system has been developed for objectively and accurately detecting IgG and IgM against SARS-CoV-2.•The levels of IgG and IgM in the patients and cured population have been primarily investigated by the POCT system.•The alterations of IgG and IgM levels in two hospital patients have been monitored by the POCT system. The coronavirus disease 2019 (COVID-19) epidemic continues to ravage the world. In epidemic control, dealing with a large number of samples is a huge challenge. In this study, a point-of-care test (POCT) system was successfully developed and applied for rapid and accurate detection of immunoglobulin-G and -M against nucleocapsid protein (anti-N IgG/IgM) and receptor-binding domain in spike glycoprotein (anti-S-RBD IgG/IgM) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Any one of the IgG/IgM found in a sample was identified as positive. The POCT system contains colloidal gold-based lateral flow immunoassay test strips, homemade portable reader, and certified reference materials, which detected anti-N and anti-S-RBD IgG/IgM objectively in serum within 15 min. Receiver operating characteristic curve analysis was used to determine the optimal cutoff values, sensitivity, and specificity. It exhibited equal to or better performances than four approved commercial kits. Results of the system and chemiluminescence immunoassay kit detecting 108 suspicious samples had high consistency with kappa coefficient at 0.804 (P < 0.001). Besides, the levels and alterations of the IgG/IgM in an inpatient were primarily investigated by the POCT system. Those results suggested the POCT system possess the potential to contribute to rapid and accurate serological diagnosis and epidemiological survey of COVID-19.