• Zhao Rongqing, Maohua Li, Hao Song, Jianxin Chen, Wenlin Ren, Yingmei Feng, George F Gao, Jinwen Song, Ya Peng, Bin Su, Xianghua Guo, Yanjun Wang, Jingong Chen, Jianli Li, Hunter Sun, Zhonghu Bai, Wenjing Cao, Jin Zhu, Qinlu Zhang, Yufei Sun, Sean Sun, Xinkun Mao, Junchi Su, Xiang Chen, Ailiang He, Wen Gao, Ronghua Jin, Yongzhong Jiang, and Le Sun.
• AnyGo Technology Co, Ltd, Beijing, China.
• Clin. Infect. Dis. 2020 Nov 19; 71 (16): 2066-2072.

BackgroundThousands of medical staff have been infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), with hundreds of deaths reported. Such loss could be prevented if there were a serologic assay for SARS-CoV-2-specific antibodies for serological surveillance of its infection at the early stage of disease.MethodsUsing Chinese hamster ovarian (CHO) cell-expressed full-length SARS-CoV-2 S1 protein as capturing antigen, a coronavirus disease 2019 (COVID-19)/SARS-CoV-2 S1 serology enzyme-linked immunosorbent assay (ELISA) kit was developed and validated with negative samples collected prior to the outbreak or during the outbreak and positive samples from patients confirmed with COVID-19.ResultsThe 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 1 after the onset of COVID-19 disease. The average antibody levels increased during hospitalization and 14 days after discharge. SARS-CoV-2 antibodies were detected in 28 of 276 asymptomatic medical staff and 1 of 5 nucleic acid test-negative "close contacts" of COVID-19 patients.ConclusionsWith the assays developed here, we can screen medical staff, incoming 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 further spread of the virus.© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

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