Emerging Microbes & Infections ( IF 13.2 ) Pub Date : 2020-09-18 , DOI: 10.1080/22221751.2020.1811161 Chunyan Zhang 1 , Lei Zhou 2, 3 , Hao Liu 2, 3 , Sibing Zhang 1, 2 , Yaping Tian 1 , Junli Huo 2, 3 , Fei Li 2, 3 , Yao Zhang 2, 3 , Bo Wei 2, 4 , Dan Xu 5 , Jinwei Hu 5 , Jiayi Wang 2, 3 , Yuxuan Cheng 1 , Wenjie Shi 1 , Xiuli Xu 6 , Jianping Zhou 6 , Peipei Sang 1 , Xudong Tan 1 , Weiwei Wang 1 , Minjie Zhang 1 , Bin Wang 5 , Yujun Zhou 1 , Kan Zhang 2, 3 , Kunlun He 1
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.