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Serological immunochromatographic approach in diagnosis with SARS-CoV-2 infected COVID-19 patients.

Authors
  • Pan, Yunbao1
  • Li, Xinran2
  • Yang, Gui1
  • Fan, Junli1
  • Tang, Yueting1
  • Zhao, Jin1
  • Long, Xinghua1
  • Guo, Shuang1
  • Zhao, Ziwu1
  • Liu, Yinjuan1
  • Hu, Hanning1
  • Xue, Han3
  • Li, Yirong4
  • 1 Department of Laboratory Medicine, Zhongnan Hospital of Wuhan University, Wuhan University, No.169 Donghu Road, Wuhan, Hubei, China. , (China)
  • 2 Department of Laboratory Medicine, Zhongnan Hospital of Wuhan University, Wuhan University, No.169 Donghu Road, Wuhan, Hubei, China; School of Biomedical Sciences, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China. , (China)
  • 3 Department of Laboratory Medicine, Zhongnan Hospital of Wuhan University, Wuhan University, No.169 Donghu Road, Wuhan, Hubei, China. Electronic address: [email protected] , (China)
  • 4 Department of Laboratory Medicine, Zhongnan Hospital of Wuhan University, Wuhan University, No.169 Donghu Road, Wuhan, Hubei, China. Electronic address: [email protected] , (China)
Type
Published Article
Journal
The Journal of infection
Publication Date
Jul 01, 2020
Volume
81
Issue
1
Identifiers
DOI: 10.1016/j.jinf.2020.03.051
PMID: 32283141
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

An outbreak of new coronavirus SARS-CoV-2 was occurred in Wuhan, China and rapidly spread to other cities and nations. The standard diagnostic approach that widely adopted in the clinic is nucleic acid detection by real-time RT-PCR. However, the false-negative rate of the technique is unneglectable and serological methods are urgently warranted. Here, we presented the colloidal gold-based immunochromatographic (ICG) strip targeting viral IgM or IgG antibody and compared it with real-time RT-PCR. The sensitivity of ICG assay with IgM and IgG combinatorial detection in nucleic acid confirmed cases were 11.1%, 92.9% and 96.8% at the early stage (1-7 days after onset), intermediate stage (8-14 days after onset), and late stage (more than 15 days), respectively. The ICG detection capacity in nucleic acid-negative suspected cases was 43.6%. In addition, the concordance of whole blood samples and plasma showed Cohen's kappa value of 0.93, which represented the almost perfect agreement between two types of samples. In conclusion, serological ICG strip assay in detecting SARS-CoV-2 infection is both sensitive and consistent, which is considered as an excellent supplementary approach in clinical application. Copyright © 2020 Elsevier Ltd. All rights reserved.

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