Establishing a high sensitivity detection method for SARS-CoV-2 IgM/IgG and developing a clinical application of this method

• Published in: Emerging microbes & infections 2020-01, Vol.9 (1), p.2020-2029
• Main Authors: Zhang, Chunyan, Zhou, Lei, Liu, Hao, Zhang, Sibing, Tian, Yaping, Huo, Junli, Li, Fei, Zhang, Yao, Wei, Bo, Xu, Dan, Hu, Jinwei, Wang, Jiayi, Cheng, Yuxuan, Shi, Wenjie, Xu, Xiuli, Zhou, Jianping, Sang, Peipei, Tan, Xudong, Wang, Weiwei, Zhang, Minjie, Wang, Bin, Zhou, Yujun, Zhang, Kan, He, Kunlun
• Format: Article
• Language: English
• Subjects: Antibodies, Viral - analysis; Coronaviruses; COVID-19; COVID-19 - diagnosis; COVID-19 - immunology; COVID-19 Serological Testing - methods; disease evaluation; Fluorescent Antibody Technique; Humans; Immunoglobulin G - analysis; Immunoglobulin M - analysis; multi-epitopes fusion protein; prognosis; SARS-CoV-2 - immunology; SARS-CoV-2 antibody; Sensitivity and Specificity; Severe acute respiratory syndrome coronavirus 2; time-resolved fluorescence immunoassay
• ISSN: 2222-1751; 2222-1751
• DOI: 10.1080/22221751.2020.1811161

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.