A Peptide-Based Magnetic Chemiluminescence Enzyme Immunoassay for Serological Diagnosis of Coronavirus Disease 2019

Author:

Cai Xue-fei1,Chen Juan1,li Hu Jie-1,Long Quan-xin1,Deng Hai-jun1,Liu Ping2,Fan Kai3,Liao Pu4,Liu Bei-zhong5,Wu Gui-cheng6,Chen Yao-kai7,Li Zhi-jie4,Wang Kun4,Zhang Xiao-li5,Tian Wen-guang5,Xiang Jiang-lin6,Du Hong-xin6,Wang Jing7,Hu Yuan1,Tang Ni1,Lin Yong1,Ren Ji-hua1,Huang Lu-yi1,Wei Jie1,Gan Chun-yang1,Chen Yan-meng1,Gao Qing-zhu1,Chen A-mei1,He Chang-long1,Wang Dao-Xin8,Hu Peng1,Zhou Fa-Chun9,Huang Ai-long1,Wang De-qiang110

Affiliation:

1. Key Laboratory of Molecular Biology on Infectious Diseases, Ministry of Education, Chongqing Medical University, Chongqing, China

2. BioScience Co. LTD, Tianjin, China

3. PEG-Bio Biopharm Co. LTD., Chongqing, China

4. Laboratory Department, Chongqing People’s Hospital, Chongqing, China

5. Yongchuan Hospital Affiliated to Chongqing Medical University, Chongqing, China

6. Chongqing Three Gorges Central Hospital, Chongqing, China

7. The Public Health Center, Chongqing, China

8. Department of Respiration, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China

9. Department of Emergency, The First Affiliated Hospital, Chongqing Medical University, Chongqing, China

10. College of Laboratory Medicine, Chongqing Medical University, Chongqing, China

Abstract

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.

Funder

National Science and Technology Planning Project

Chongqing Natural Science Foundation

Natural Science Foundation of Chongqing Yuzhong

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Immunology and Allergy

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