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Validation of a SARS-CoV-2 spike protein ELISA for use in contact investigations and sero-surveillance

Brandi Freeman, Sandra Lester, Lisa Mills, Mohammad Ata Ur Rasheed, Stefany Moye, Olubukola Abiona, Geoffrey B. Hutchinson, Maria Morales-Betoulle, Inna Krapinunaya, Ardith Gibbons, Cheng-Feng Chiang, Deborah Cannon, John Klena, Jeffrey A. Johnson, Sherry Michele Owen, View ORCID ProfileBarney S. Graham, Kizzmekia S. Corbett, View ORCID ProfileNatalie J. Thornburg
doi: https://doi.org/10.1101/2020.04.24.057323
Brandi Freeman
1Centers for Disease Control and Prevention, Atlanta GA
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Sandra Lester
2Synergy America, Inc, Duluth GA
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Lisa Mills
3Eagle global Scientific, LLC, Atlanta, GA
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Mohammad Ata Ur Rasheed
2Synergy America, Inc, Duluth GA
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Stefany Moye
3Eagle global Scientific, LLC, Atlanta, GA
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Olubukola Abiona
4Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda MD
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Geoffrey B. Hutchinson
4Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda MD
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Maria Morales-Betoulle
1Centers for Disease Control and Prevention, Atlanta GA
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Inna Krapinunaya
1Centers for Disease Control and Prevention, Atlanta GA
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Ardith Gibbons
1Centers for Disease Control and Prevention, Atlanta GA
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Cheng-Feng Chiang
1Centers for Disease Control and Prevention, Atlanta GA
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Deborah Cannon
1Centers for Disease Control and Prevention, Atlanta GA
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John Klena
1Centers for Disease Control and Prevention, Atlanta GA
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Jeffrey A. Johnson
1Centers for Disease Control and Prevention, Atlanta GA
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Sherry Michele Owen
1Centers for Disease Control and Prevention, Atlanta GA
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Barney S. Graham
4Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda MD
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  • ORCID record for Barney S. Graham
Kizzmekia S. Corbett
4Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda MD
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Natalie J. Thornburg
1Centers for Disease Control and Prevention, Atlanta GA
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  • ORCID record for Natalie J. Thornburg
  • For correspondence: Nax3@cdc.gov
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Abstract

Since emergence of SARS-CoV-2 in late 2019, there has been a critical need to understand prevalence, transmission patterns, to calculate the burden of disease and case fatality rates. Molecular diagnostics, the gold standard for identifying viremic cases, are not ideal for determining true case counts and rates of asymptomatic infection. Serological detection of SARS-CoV-2 specific antibodies can contribute to filling these knowledge gaps. In this study, we describe optimization and validation of a SARS-CoV-2-specific-enzyme linked immunosorbent assay (ELISA) using the prefusion-stabilized form of the spike protein [1]. We performed receiver operator characteristic (ROC) analyses to define the specificities and sensitivities of the optimized assay and examined cross reactivity with immune sera from persons confirmed to have had infections with other coronaviruses. These assays will be used to perform contact investigations and to conduct large-scale, cross sectional surveillance to define disease burden in the population.

Competing Interest Statement

The authors have declared no competing interest.

Footnotes

  • One discussion point added to text.

Copyright 
The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license.
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Posted April 25, 2020.
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Validation of a SARS-CoV-2 spike protein ELISA for use in contact investigations and sero-surveillance
Brandi Freeman, Sandra Lester, Lisa Mills, Mohammad Ata Ur Rasheed, Stefany Moye, Olubukola Abiona, Geoffrey B. Hutchinson, Maria Morales-Betoulle, Inna Krapinunaya, Ardith Gibbons, Cheng-Feng Chiang, Deborah Cannon, John Klena, Jeffrey A. Johnson, Sherry Michele Owen, Barney S. Graham, Kizzmekia S. Corbett, Natalie J. Thornburg
bioRxiv 2020.04.24.057323; doi: https://doi.org/10.1101/2020.04.24.057323
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Validation of a SARS-CoV-2 spike protein ELISA for use in contact investigations and sero-surveillance
Brandi Freeman, Sandra Lester, Lisa Mills, Mohammad Ata Ur Rasheed, Stefany Moye, Olubukola Abiona, Geoffrey B. Hutchinson, Maria Morales-Betoulle, Inna Krapinunaya, Ardith Gibbons, Cheng-Feng Chiang, Deborah Cannon, John Klena, Jeffrey A. Johnson, Sherry Michele Owen, Barney S. Graham, Kizzmekia S. Corbett, Natalie J. Thornburg
bioRxiv 2020.04.24.057323; doi: https://doi.org/10.1101/2020.04.24.057323

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