Standardization of ELISA protocols for serosurveys of the SARS-CoV-2 pandemic using clinical and at-home blood sampling

Carleen Klumpp-Thomas, Heather Kalish, Matthew Drew, Sally Hunsberger, Kelly Snead, Michael P. Fay, Jennifer Mehalko, Anandakumar Shunmugavel, Vanessa Wall, Peter Frank, John-Paul Denson, Min Hong, Gulcin Gulten, Simon Messing, Jennifer Hicks, Sam Michael, William Gillette, Matthew D. Hall, Matthew J. Memoli, Dominic Esposito and Kaitlyn Sadtler ()
Additional contact information
Carleen Klumpp-Thomas: National Institutes of Health
Heather Kalish: National Institutes of Health
Matthew Drew: NCI RAS Initiative, Frederick National Laboratory for Cancer Research
Sally Hunsberger: National Institutes of Health
Kelly Snead: NCI RAS Initiative, Frederick National Laboratory for Cancer Research
Michael P. Fay: National Institutes of Health
Jennifer Mehalko: NCI RAS Initiative, Frederick National Laboratory for Cancer Research
Anandakumar Shunmugavel: National Institutes of Health
Vanessa Wall: NCI RAS Initiative, Frederick National Laboratory for Cancer Research
Peter Frank: NCI RAS Initiative, Frederick National Laboratory for Cancer Research
John-Paul Denson: NCI RAS Initiative, Frederick National Laboratory for Cancer Research
Min Hong: NCI RAS Initiative, Frederick National Laboratory for Cancer Research
Gulcin Gulten: NCI RAS Initiative, Frederick National Laboratory for Cancer Research
Simon Messing: NCI RAS Initiative, Frederick National Laboratory for Cancer Research
Jennifer Hicks: National Institutes of Health
Sam Michael: National Institutes of Health
William Gillette: NCI RAS Initiative, Frederick National Laboratory for Cancer Research
Matthew D. Hall: National Institutes of Health
Matthew J. Memoli: National Institutes of Health
Dominic Esposito: NCI RAS Initiative, Frederick National Laboratory for Cancer Research
Kaitlyn Sadtler: National Institutes of Health

Nature Communications, 2021, vol. 12, issue 1, 1-13

Abstract: Abstract The extent of SARS-CoV-2 infection throughout the United States population is currently unknown. High quality serology is key to avoiding medically costly diagnostic errors, as well as to assuring properly informed public health decisions. Here, we present an optimized ELISA-based serology protocol, from antigen production to data analyses, that helps define thresholds for IgG and IgM seropositivity with high specificities. Validation of this protocol is performed using traditionally collected serum as well as dried blood on mail-in blood sampling kits. Archival (pre-2019) samples are used as negative controls, and convalescent, PCR-diagnosed COVID-19 patient samples serve as positive controls. Using this protocol, minimal cross-reactivity is observed for the spike proteins of MERS, SARS1, OC43 and HKU1 viruses, and no cross reactivity is observed with anti-influenza A H1N1 HAI. Our protocol may thus help provide standardized, population-based data on the extent of SARS-CoV-2 seropositivity, immunity and infection.

Date: 2021
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DOI: 10.1038/s41467-020-20383-x

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