ABSTRACT COVID-19 is caused by SARS-CoV-2 infection and was initially discovered in Wuhan. This outbreak quickly spread all over China and then to more than 20 other countries. SARS-CoV-2 fluorescent microsphere immunochromatographic test strips were prepared by the combination of time-resolved fluorescence immunoassay with a lateral flow assay. The analytical performance and clinical evaluation of this testing method was done and the clinical significance of the testing method was verified. The LLOD of SARS-CoV-2 antibody IgG and IgM was 0.121U/L and 0.366U/L. The specificity of IgM and IgG strips in healthy people and in patients with non-COVID-19 disease was 94%, 96.72% and 95.50%, 99.49%, respectively; and sensitivity of IgM and IgG strips for patients during treatment and follow-up was 63.02%, 37.61% and 87.28%, 90.17%, respectively. The SARS-CoV-2 antibody test strip can provide rapid, flexible and accurate testing, and is able to meet the clinical requirement for rapid on-site testing of virus. The ability to detect IgM and IgG provided a significant benefit for the detection and prediction of clinical course with COVID-19 patients.
【저자키워드】 Prognosis, SARS-CoV-2 antibody, multi-epitopes fusion protein, time-resolved fluorescence immunoassay, disease evaluation, 【초록키워드】 COVID-19, Treatment, SARS-CoV-2, SARS-COV-2 infection, virus, Spread, lateral flow, China, immunoassay, test strips, sensitivity, specificity, Clinical course, SARS-CoV-2 antibody test, clinical evaluation, outbreak, Wuhan, Patient, Clinical significance, Follow-up, Antibody test, disease, patients, COVID-19 patients, microsphere, Combination, IgG and IgM, IgM and IgG, during treatment, test strip, Non-COVID-19, fluorescent, immunochromatographic test, benefit, flexible, detect, caused, healthy, provided, was done, with COVID-19, 【제목키워드】 SARS-CoV-2, sensitivity, IgM/IgG, Establishing,