Rapid, ultrasensitive and highly specific biosensor for the diagnosis of SARS-CoV-2 in clinical blood samples

In this study, a lateral flow combined IgG-IgM immunochromatographic assay is developed for the rapid, simultaneous detection of IgM and IgG antibodies against SARS-CoV-2 in clinical blood samples within 15 min. The clinical detection sensitivity and specificity of the assay strips is investigated in samples of blood from inpatients with COVID-19. The sensitivity and specificity of this assay are 85.29% and 100.00%, respectively. Compared with a single IgG and IgM test, the combined IgG-IgM immunochromatographic strip test has higher sensitivity. Our results demonstrate that the combined IgG-IgM immunochromatographic strip is suitable for the rapid screening of SARS-CoV-2 infection, among confirmed COVID-19 patients, suspect patients and asymptomatic SARS-CoV-2 carriers.