A Peptide-Based Magnetic Chemiluminescence Enzyme Immunoassay for Serological Diagnosis of Coronavirus Disease 2019
Xue-Fei Cai, Juan Chen, Jie Hu, Quanxin Long, Haijun Deng, Ping Liu, Kai Fan, Pu Liao, Beizhong Liu, Guicheng Wu, Yao-Kai Chen, Zhijie Li, Kun Wang, Xiaoli Zhang, Wenguang Tian, Jianglin Xiang, Hongxin Du, Jing Wang, Yuan Hu, Ni Tang, Yong Lin, Ji‐Hua Ren, Luyi Huang, Jie Wei, Chun-Yang Gan, Yanmeng Chen, Qingzhu Gao, Amei Chen, Changlong He, Daoxin Wang, Peng Hu, Fachun Zhou, Ailong Huang, Deqiang Wang
Abstract
BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a novel β-coronavirus, causes severe pneumonia and has spread throughout the globe rapidly. The disease associated with SARS-CoV-2 infection is named coronavirus disease 2019 (COVID-19). To date, real-time reverse-transcription polymerase chain reaction (RT-PCR) is the only test able to confirm this infection. However, the accuracy of RT-PCR depends on several factors; variations in these factors might significantly lower the sensitivity of detection. METHODS: In this study, we developed a peptide-based luminescent immunoassay that detected immunoglobulin (Ig)G and IgM. The assay cutoff value was determined by evaluating the sera from healthy and infected patients for pathogens other than SARS-CoV-2. RESULTS: To evaluate assay performance, we detected IgG and IgM in the sera from confirmed patients. The positive rate of IgG and IgM was 71.4% and 57.2%, respectively. CONCLUSIONS: Therefore, combining our immunoassay with real-time RT-PCR might enhance the diagnostic accuracy of COVID-19.