At the end of 2019, a novel coronavirus (CoV) appeared in Wuhan, China and has since spread to several countries and regions throughout the world. The disease caused by the novel CoV has been officially named CoV disease 2019 (COVID-19). This study provides additional data for the presence of anti-SARS-CoV-2 IgM and IgG antibodies in COVID-19 patients in Vietnam. The study also presents the development of a lateral flow immunoassay (LFA) strip for rapid simultaneous detection of the IgA/IgM/IgG antibodies against the SARS-CoV-2 virus in COVID-19 patients. The properties of the LFA test strip were evaluated by testing specimens from COVID-19 positive and negative patients confirmed by real-time PCR. Reproducibility and repeatability reached 100%. The LFA test strip did not show any cross-reactivity with 13 different pathogens and did not interfere with anticoagulants. The sensitivity and specificity of the LFA test strips were evaluated with 633 clinical samples and were found to be 91.06% and 98.74%, respectively. The Kappa statistics showed almost perfect agreement and correlation between our test strip and real-time PCR results (k coefficient = 0.902). From the obtained results, it could be suggested that the LFA test strip is a useful tool for rapid detection of antibodies against SARS-CoV-2 to accelerate epidemiological surveillance, to determine the situation of exposure to SARS-CoV-2, and to increase the diagnostic accuracy of the real-time PCR method for COVID-19.
Key words: COVID-19, SARS-CoV-2, antibody, lateral flow assay (LFA), humoral immune response, detection
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