Zhao Rongqing1, Maohua Li2, Hao Song3, Jianxin Chen4, Wenlin Ren2, Yingmei Feng5, George F Gao6, Jinwen Song7, Ya Peng3, Bin Su5, Xianghua Guo5, Yanjun Wang5, Jingong Chen4, Jianli Li2, Hunter Sun1, Zhonghu Bai8, Wenjing Cao9, Jin Zhu10, Qinlu Zhang11, Yufei Sun1, Sean Sun1, Xinkun Mao1, Junchi Su1, Xiang Chen8, Ailiang He4, Wen Gao4, Ronghua Jin5, Yongzhong Jiang12, Le Sun1,2. 1. AnyGo Technology Co, Ltd, Beijing, China. 2. AbMax Biotechnology Co, Ltd, Beijing, China. 3. Research Network of Immunity and Health, Beijing Institutes of Life Science, Chinese Academy of Sciences, Beijing, China. 4. ZhenGe Biotechnology Co, Ltd, Shanghai, China. 5. Beijing YouAn Hospital, Capital Medical University, Beijing, China. 6. Institute of Microbiology, Chinese Academy of Sciences, Beijing, China. 7. Treatment and Research Center for Infectious Diseases, Fifth Medical Center of People's Liberation Army General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China. 8. School of Biotechnology, Jiangnan University, Wuxi, Jiangsu, China. 9. Bengbu Medical University, Bengbu, Anhui, China. 10. Department of Laboratory, Quzhou People's Hospital, Quzhou, Zhejiang, China. 11. ShaanXi Provincial Engineering Research Center for Nano-BioMedical Detection, Xi'an, Shaanxi, China. 12. Hubei Provincial Center for Disease Control and Prevention, Wuhan, China.
Abstract
BACKGROUND: Thousands 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. METHODS: Using 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. 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 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. CONCLUSIONS: With 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.
BACKGROUND: Thousands 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. METHODS: Using Chinese hamster ovarian (CHO) cell-expressed full-length SARS-CoV-2S1 protein as capturing antigen, a coronavirus disease 2019 (COVID-19)/SARS-CoV-2S1 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. 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-19patients. 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-19patients. CONCLUSIONS: With 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.
Authors: Tongqing Zhou; I-Ting Teng; Adam S Olia; Gabriele Cerutti; Jason Gorman; Alexandra Nazzari; Wei Shi; Yaroslav Tsybovsky; Lingshu Wang; Shuishu Wang; Baoshan Zhang; Yi Zhang; Phinikoula S Katsamba; Yuliya Petrova; Bailey B Banach; Ahmed S Fahad; Lihong Liu; Sheila N Lopez Acevedo; Bharat Madan; Matheus Olivera de Souza; Xiaoli Pan; Pengfei Wang; Jacy R Wolfe; Michael Yin; David D Ho; Emily Phung; Anthony DiPiazza; Lauren Chang; Olubukula Abiona; Kizzmekia S Corbett; Brandon J DeKosky; Barney S Graham; John R Mascola; John Misasi; Tracy Ruckwardt; Nancy J Sullivan; Lawrence Shapiro; Peter D Kwong Journal: SSRN Date: 2020-07-21
Authors: Fainareti N Zervou; Ping Louie; Anna Stachel; Ioannis M Zacharioudakis; Yadira Ortiz-Mendez; Kristen Thomas; Maria E Aguero-Rosenfeld Journal: J Med Virol Date: 2021-05-12 Impact factor: 20.693
Authors: Richard J Martino; Kristen D Krause; Marybec Griffin; Caleb LoSchiavo; Camilla Comer-Carruthers; Anita G Karr; Allie F Bullock; Perry N Halkitis Journal: Public Health Rep Date: 2021-05-25 Impact factor: 3.117
Authors: Andrea P Espejo; Yamac Akgun; Abdulaziz F Al Mana; Youley Tjendra; Nicolas C Millan; Carmen Gomez-Fernandez; Carolyn Cray Journal: Am J Clin Pathol Date: 2020-08-05 Impact factor: 2.493
Authors: Micah T McClain; Florica J Constantine; Ricardo Henao; Yiling Liu; Ephraim L Tsalik; Thomas W Burke; Julie M Steinbrink; Elizabeth Petzold; Bradly P Nicholson; Robert Rolfe; Bryan D Kraft; Matthew S Kelly; Gregory D Sempowski; Thomas N Denny; Geoffrey S Ginsburg; Christopher W Woods Journal: medRxiv Date: 2020-07-26