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A new and rapid approach for detecting COVID-19 based on S1 protein fragments.
Li, Hua; Liu, Zhe; He, Yue; Qi, Yingjie; Chen, Jie; Ma, Yuanyuan; Liu, Fujia; Lai, Kaisheng; Zhang, Yong; Jiang, Liu; Wang, Xiangdong; Ge, Junbo.
  • Li H; Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Shanghai Xuhui District Central Hospital & Zhongshan-xuhui Hospital, Zhongshan Hospital, Fudan University, Shanghai, China.
  • Liu Z; Department of Medicine, BestNovo (Beijing) Medical Technology Co., Ltd, Beijing, China.
  • He Y; Department of Cardiology, Shanghai Xuhui District Central Hospital & Zhongshan-xuhui Hospital, Shanghai, China.
  • Qi Y; Division of Life Sciences and Medicine, The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, 230000, China.
  • Chen J; Department of Laboratory Medicine, Shanghai Xuhui District Central Hospital & Zhongshan-xuhui Hospital, Shanghai, China.
  • Ma Y; Shanghai Public Health Clinical Center, Clinical Trial Institution, Shanghai, China.
  • Liu F; Department of Medicine, BestNovo (Beijing) Medical Technology Co., Ltd, Beijing, China.
  • Lai K; Department of Medicine, BestNovo (Beijing) Medical Technology Co., Ltd, Beijing, China.
  • Zhang Y; Department of Medicine, BestNovo (Beijing) Medical Technology Co., Ltd, Beijing, China.
  • Jiang L; Department of Medicine, BestNovo (Beijing) Medical Technology Co., Ltd, Beijing, China.
  • Wang X; Institute of Clinical Science, Zhongshan Hospital, Fudan University, Shanghai, China.
  • Ge J; Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Shanghai Xuhui District Central Hospital & Zhongshan-xuhui Hospital, Zhongshan Hospital, Fudan University, Shanghai, China.
Clin Transl Med ; 10(2): e90, 2020 Jun.
Article in English | MEDLINE | ID: covidwho-583657
ABSTRACT
The pandemic of novel coronavirus disease 2019 (COVID-19) seriously threatened the public health all over the world. A colloidal gold immunochromatography assay for IgM/IgG antibodies against the receptor-binding domain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) S1 protein was established to assess its rapid diagnostic value. We first designed and manufactured all contents of the test cassette of SARS-CoV-2 rapid test kit the colloidal gold-labeled mouse-antihuman lgM/lgG antibody, the recombinant SARS-CoV-2 antigen, the nitrocellulose membrane control line, and specimen diluents. Furthermore, reverse transcription-polymerase chain reaction (RT-PCR) assay, colloidal gold immunochromatography assay, serological validation of cross reaction with other common viruses, and clinical validation were performed. The kit was finally evaluated by 75 serum/plasma samples of SARS-CoV-2 infection cases and 139 healthy samples as control, with the result of that the sensitivity, specificity, and accuracy for IgM were 90.67%, 97.84%, and 95.33%, whereas for IgG were 69.33%, 99.28%, and 88.79%, respectively; the combination of IgM and IgG could improve the value 92.00%, 97.12%, and 95.33%, respectively. Therefore, the rapid detection kit has high sensitivity and specificity, especially for IgM&IgG, showing a critical value in clinical application and epidemic control of COVID-19.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Language: English Journal: Clin Transl Med Year: 2020 Document Type: Article Affiliation country: Ctm2.90

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Language: English Journal: Clin Transl Med Year: 2020 Document Type: Article Affiliation country: Ctm2.90