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Performance of Three SARS-CoV-2 Immunoassays, Three Rapid Lateral Flow Tests, and a Novel Bead-Based Affinity Surrogate Test for the Detection of SARS-CoV-2 Antibodies in Human Serum.

Authors
  • Krone, Manuel1
  • Gütling, Julia1
  • Wagener, Johannes1, 2
  • Lâm, Thiên-Trí1
  • Schoen, Christoph1
  • Vogel, Ulrich1
  • Stich, August3
  • Wedekink, Florian4
  • Wischhusen, Jörg4
  • Kerkau, Thomas5
  • Beyersdorf, Niklas5
  • Klingler, Silvana6
  • Backes, Simone5
  • Dölken, Lars5
  • Gasteiger, Georg6
  • Kurzai, Oliver1
  • Schubert-Unkmeir, Alexandra1
  • 1 Institute for Hygiene and Microbiology, University of Wuerzburg, Wuerzburg, Germany. , (Germany)
  • 2 Department of Clinical Microbiology, Trinity College Dublin, Dublin, Ireland. , (Ireland)
  • 3 Department of Tropical Medicine, Missioklinik, Klinikum Wuerzburg Mitte, Wuerzburg, Germany. , (Germany)
  • 4 Department of Gynecology, Section for Experimental Tumor Immunology, University Hospital Wuerzburg, Wuerzburg, Germany. , (Germany)
  • 5 Institute for Virology and Immunobiology, University of Wuerzburg, Wuerzburg, Germany. , (Germany)
  • 6 Institute of Systems Immunology, University of Wuerzburg, Wuerzburg, Germany. , (Germany)
Type
Published Article
Journal
Journal of Clinical Microbiology
Publisher
American Society for Microbiology
Publication Date
Jul 19, 2021
Volume
59
Issue
8
Identifiers
DOI: 10.1128/JCM.00319-21
PMID: 33962959
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

For the control of immunity in COVID-19 survivors and vaccinated subjects, there is an urgent need for reliable and rapid serological assays. Based on samples from 63 COVID-19 survivors up to 7 months after symptom onset, and on 50 serum samples taken before the beginning of the pandemic, we compared the performances of three commercial immunoassays for the detection of SARS-CoV-2 IgA and IgG antibodies (Euroimmun SARS-COV-2 IgA/IgG, Mikrogen recomWell SARS-CoV-2 IgA/IgG, and Serion ELISA agile SARS-CoV-2 IgA/IgG) and three rapid lateral flow (immunochromatographic) tests (Abbott PanBio COVID-19 IgG/IgM, Nadal COVID-19 IgG/IgM, and Cleartest Corona 2019-nCOV IgG/IgM) with a 50% plaque-reduction neutralization test (PRNT50) representing the gold standard. Fifty-seven out of 63 PCR-confirmed COVID-19 patients (90%) showed neutralizing antibodies. The sensitivity of the seven assays ranged from 7.0% to 98.3%, and the specificity ranged from 86.0% to 100.0%. Only one commercial immunoassay showed a sensitivity and specificity of greater than 98%.

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