Development of a Sensitive Immunochromatographic Method Using Lanthanide Fluorescent Microsphere for Rapid Serodiagnosis of COVID-19.

The SARS-CoV-2 infection that caused the COVID-19 pandemic quickly spread worldwide within two months. Rapid diagnosis of the disease and isolation of patients are effective ways to prevent and control the spread of COVID-19. Therefore, a sensitive immunofluorescent assay method was developed for rapid detection of special IgM and IgG of COVID-19 in human serum within 10 min. The recombinant nucleocapsid protein of 2019 novel coronavirus was used as capture antigen. Lanthanide, Eu(III) fluorescent microsphere, was used to qualitatively/semiquantitatively determine the solid phase immunochromatographic assay. A total of 28 clinical positive and 77 negative serum or plasma samples were included in the test. Based on the analysis of serum or plasma from COVID-19 patients and healthy people, the sensitivity and specificity of the immunochromatographic assay were calculated as 98.72% and 100% (IgG), and 98.68% and 93.10% (IgM), respectively. The results demonstrated that rapid immunoassay has high sensitivity and specificity and was useful for rapid serodiagnosis of COVID-19.