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Evaluation of the EUROIMMUN Anti-SARS-CoV-2 ELISA Assay for detection of IgA and IgG antibodies

Scott M. Matushek, View ORCID ProfileKathleen G. Beavis, Ana Abeleda, Cindy Bethel, Carlissa Hunt, Stephanie Gillen, Angelica Moran, View ORCID ProfileVera Tesic
doi: https://doi.org/10.1101/2020.05.11.089862
Scott M. Matushek
bClinical Microbiology and Immunology Laboratory, University of Chicago Medicine, Chicago, Illinois, USA
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Kathleen G. Beavis
aDepartment of Pathology, University of Chicago, Chicago, Illinois, USA
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  • For correspondence: KBeavis@uchicago.edu
Ana Abeleda
bClinical Microbiology and Immunology Laboratory, University of Chicago Medicine, Chicago, Illinois, USA
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Cindy Bethel
bClinical Microbiology and Immunology Laboratory, University of Chicago Medicine, Chicago, Illinois, USA
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Carlissa Hunt
bClinical Microbiology and Immunology Laboratory, University of Chicago Medicine, Chicago, Illinois, USA
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Stephanie Gillen
bClinical Microbiology and Immunology Laboratory, University of Chicago Medicine, Chicago, Illinois, USA
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Angelica Moran
aDepartment of Pathology, University of Chicago, Chicago, Illinois, USA
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Vera Tesic
aDepartment of Pathology, University of Chicago, Chicago, Illinois, USA
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  • ORCID record for Vera Tesic
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Abstract

As the Coronavirus 2019 (COVID-19) pandemic evolves, the development of immunoassays to help determine exposure and potentially predict immunity has become a pressing priority. In this report we present the performance of the EUROIMMUN enzyme-linked immunosorbent assay (ELISA) for semi-quantitative detection of IgA and IgG antibodies in serum and plasma samples using recombinant S1 domain of the SARS-CoV-2 spike protein as antigen. Specimens from patients, with and without COVID-19 infection, were tested at the University of Chicago Clinical Microbiology and Immunology Laboratory. Of 57 samples from COVID-19 PCR-negative patients, including 28 samples positive for common human coronavirus strains, 53 tested negative and 4 tested positive for IgA (93.0% agreement) while 56 tested negative and 1 tested positive for IgG (98.2% agreement). For COVID-19 PCR-positive patients, 29 of 30 (96.7%) samples collected ≥3 days after positive PCR were positive for IgA, and 28 of 28 samples collected ≥4 days after positive PCR were positive for IgG.

The EUROIMMUN Anti-SARS-CoV-2 ELISA Assay demonstrates excellent sensitivity for detection of IgA and IgG antibodies from samples collected ≥3 days and ≥4 days, respectively, after COVID-19 diagnosis by PCR. This assay did not demonstrate cross reaction in any of the 28 samples from patients with common human coronaviruses, including types HKU1, NL63, CV229E, and OC43.

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The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license.
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Posted May 13, 2020.
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Evaluation of the EUROIMMUN Anti-SARS-CoV-2 ELISA Assay for detection of IgA and IgG antibodies
Scott M. Matushek, Kathleen G. Beavis, Ana Abeleda, Cindy Bethel, Carlissa Hunt, Stephanie Gillen, Angelica Moran, Vera Tesic
bioRxiv 2020.05.11.089862; doi: https://doi.org/10.1101/2020.05.11.089862
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Evaluation of the EUROIMMUN Anti-SARS-CoV-2 ELISA Assay for detection of IgA and IgG antibodies
Scott M. Matushek, Kathleen G. Beavis, Ana Abeleda, Cindy Bethel, Carlissa Hunt, Stephanie Gillen, Angelica Moran, Vera Tesic
bioRxiv 2020.05.11.089862; doi: https://doi.org/10.1101/2020.05.11.089862

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