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. 2020 Jun 29;222(2):189-193.
doi: 10.1093/infdis/jiaa243.

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

Xue-Fei Cai  1 , Juan Chen  1 , Jie- Li Hu  1 , Quan-Xin Long  1 , Hai-Jun Deng  1 , Ping Liu  2 , Kai Fan  3 , Pu Liao  4 , Bei-Zhong Liu  5 , Gui-Cheng Wu  6 , Yao-Kai Chen  7 , Zhi-Jie Li  4 , Kun Wang  4 , Xiao-Li Zhang  5 , Wen-Guang Tian  5 , Jiang-Lin Xiang  6 , Hong-Xin Du  6 , Jing Wang  7 , Yuan Hu  1 , Ni Tang  1 , Yong Lin  1 , Ji-Hua Ren  1 , Lu-Yi Huang  1 , Jie Wei  1 , Chun-Yang Gan  1 , Yan-Meng Chen  1 , Qing-Zhu Gao  1 , A-Mei Chen  1 , Chang-Long He  1 , Dao-Xin Wang  8 , Peng Hu  1 , Fa-Chun Zhou  9 , Ai-Long Huang  1 , De-Qiang Wang  1   10
Affiliations

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

Xue-Fei Cai et al. J Infect Dis. .

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.

Keywords: COVID-19; SARS-CoV-2; chemiluminescence immunoassay; serological test.

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