Early detection of SARS-CoV-2 antibodies in COVID-19 patients as a serologic marker of infection

Zhao, Rongqing; Li, Maohua; Song, Hao; Chen, Jianxin; Ren, Wenlin; Feng, Yingmei; Gao, George F; Song, Jinwen; Peng, Ya; Su, Bin; Guo, Xianghua; Wang, Yanjun; Chen, Jingong; Li, Jianli; Sun, Hunter; Bai, Zhonghu; Cao, WenJing; Zhu, Jin; Zhang, Qinlu; Sun, Yufei; Sun, Sean; Mao, Xinkun; Su, Junchi; Chen, Xiang; He, Ailiang; Gao, Wen; Jin, Ronghua; Jiang, Yongzhong; Sun, Le

BACKGROUND: Thousands of medical staff had been infected with SARS-CoV-2 virus with hundreds of deaths reported. Such loss could be prevented if there is a serologic assay for SARS-CoV-2-specific antibodies for serological surveillance of its infection at the early stage of disease. METHODS: Using CHO cell expressed full length SARS-CoV-2 S1 protein as capturing antigen, a COVID-19/SARS-CoV-2 S1 serology ELISA kit was developed and validated with negative samples collected prior to the outbreaks or during the outbreak, and positive samples from patients confirmed with COVID-19. RESULTS: The specificity of the ELISA kit was 97.5%, as examined against total 412 normal human samples. The sensitivity was 97.1% by testing against 69 samples from hospitalized and/or recovered COVID-19 patients. The overall accuracy rate reached 97.3%. The assay was able to detect SARS-CoV-2 antibody on day one after the onset of COVID-19 disease. The average antibody levels increased during the hospitalization and after been discharged for two weeks. SARS-CoV-2 antibodies were detected in 28 out of 276 asymptomatic medical staff and one out of five nucleic acid test-negative “Close contacts” of COVID-19 patient. CONCLUSION: With the assays developed here, we can screen medical staff, in-coming patients, passengers and people who are in close contact with the confirmed patients to identify the “innocent viral spreaders”, protect the medical staff and stop the further spreading of the virus.