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

• Published in: The Journal of infectious diseases Vol. 222; no. 2; pp. 189 - 193
• Main Authors: Cai, Xue-fei, Chen, Juan, li Hu, Jie, Long, Quan-xin, Deng, Hai-jun, Liu, Ping, Fan, Kai, Liao, Pu, Liu, Bei-zhong, Wu, Gui-cheng, Chen, Yao-kai, Li, Zhi-jie, Wang, Kun, Zhang, Xiao-li, Tian, Wen-guang, Xiang, Jiang-lin, Du, Hong-xin, Wang, Jing, Hu, Yuan, Tang, Ni, Lin, Yong, Ren, Ji-hua, Huang, Lu-yi, Wei, Jie, Gan, Chun-yang, Chen, Yan-meng, Gao, Qing-zhu, Chen, A-mei, He, Chang-long, Wang, Dao-Xin, Hu, Peng, Zhou, Fa-Chun, Huang, Ai-long, Wang, De-qiang
• Format: Journal Article
• Language: English
• Published: US Oxford University Press 29.06.2020
• Subjects: Adult; Antibodies, Viral - blood; Betacoronavirus - immunology; Chemiluminescence; Clinical Laboratory Techniques - methods; Coronaviridae; Coronavirus Infections - diagnosis; Coronavirus Infections - immunology; Coronaviruses; COVID-19; COVID-19 Testing; COVID-19 Vaccines; Enzyme immunoassay; Female; Humans; Immunoassay; Immunoenzyme Techniques - methods; Immunoglobulin G; Immunoglobulin G - blood; Immunoglobulin M; Immunoglobulin M - blood; Luminescent Measurements; Major; Male; Medical diagnosis; Middle Aged; Pandemics; Peptides; Peptides - immunology; Pneumonia, Viral - diagnosis; Pneumonia, Viral - immunology; Polymerase chain reaction; Real-Time Polymerase Chain Reaction; Reverse Transcriptase Polymerase Chain Reaction; SARS-CoV-2; Sensitivity and Specificity; Serologic Tests - methods; Severe acute respiratory syndrome coronavirus 2; Viral Proteins - immunology; COVID-19; serological test; SARS-CoV-2; chemiluminescence immunoassay
• ISSN: 0022-1899; 1537-6613; 1537-6613
• DOI: 10.1093/infdis/jiaa243

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. A peptide-based magnetic chemiluminescence enzyme immunoassay for the detection of SARS-CoV-2 antibodies was developed; 71.4% (197 of 276) and 57.2% (158 of 276) of the COVID-19 inpatients were positive for IgG and IgM against SARS-CoV-2.