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Standardization of ELISA protocols for serosurveys of the SARS-CoV-2 pandemic using clinical and at-home blood sampling.
Klumpp-Thomas, Carleen; Kalish, Heather; Drew, Matthew; Hunsberger, Sally; Snead, Kelly; Fay, Michael P; Mehalko, Jennifer; Shunmugavel, Anandakumar; Wall, Vanessa; Frank, Peter; Denson, John-Paul; Hong, Min; Gulten, Gulcin; Messing, Simon; Hicks, Jennifer; Michael, Sam; Gillette, William; Hall, Matthew D; Memoli, Matthew J; Esposito, Dominic; Sadtler, Kaitlyn.
  • Klumpp-Thomas C; National Center for Advancing Translational Sciences, National Institutes of Health, Rockville, MD, 20850, USA.
  • Kalish H; Section on Immuno-Engineering, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Bethesda, MD, 20894, USA.
  • Drew M; Trans-NIH Shared Resource on Biomedical Engineering and Physical Science, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Bethesda, MD, 20894, USA.
  • Hunsberger S; Protein Expression Laboratory, NCI RAS Initiative, Frederick National Laboratory for Cancer Research, Frederick, MD, 21702, USA.
  • Snead K; Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, 20894, USA.
  • Fay MP; Protein Expression Laboratory, NCI RAS Initiative, Frederick National Laboratory for Cancer Research, Frederick, MD, 21702, USA.
  • Mehalko J; Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, 20894, USA.
  • Shunmugavel A; Protein Expression Laboratory, NCI RAS Initiative, Frederick National Laboratory for Cancer Research, Frederick, MD, 21702, USA.
  • Wall V; Section on Immuno-Engineering, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Bethesda, MD, 20894, USA.
  • Frank P; Protein Expression Laboratory, NCI RAS Initiative, Frederick National Laboratory for Cancer Research, Frederick, MD, 21702, USA.
  • Denson JP; Protein Expression Laboratory, NCI RAS Initiative, Frederick National Laboratory for Cancer Research, Frederick, MD, 21702, USA.
  • Hong M; Protein Expression Laboratory, NCI RAS Initiative, Frederick National Laboratory for Cancer Research, Frederick, MD, 21702, USA.
  • Gulten G; Protein Expression Laboratory, NCI RAS Initiative, Frederick National Laboratory for Cancer Research, Frederick, MD, 21702, USA.
  • Messing S; Protein Expression Laboratory, NCI RAS Initiative, Frederick National Laboratory for Cancer Research, Frederick, MD, 21702, USA.
  • Hicks J; Protein Expression Laboratory, NCI RAS Initiative, Frederick National Laboratory for Cancer Research, Frederick, MD, 21702, USA.
  • Michael S; Trans-NIH Shared Resource on Biomedical Engineering and Physical Science, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Bethesda, MD, 20894, USA.
  • Gillette W; National Center for Advancing Translational Sciences, National Institutes of Health, Rockville, MD, 20850, USA.
  • Hall MD; Protein Expression Laboratory, NCI RAS Initiative, Frederick National Laboratory for Cancer Research, Frederick, MD, 21702, USA.
  • Memoli MJ; National Center for Advancing Translational Sciences, National Institutes of Health, Rockville, MD, 20850, USA.
  • Esposito D; LID Clinical Studies Unit, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, 20894, USA.
  • Sadtler K; Protein Expression Laboratory, NCI RAS Initiative, Frederick National Laboratory for Cancer Research, Frederick, MD, 21702, USA.
Nat Commun ; 12(1): 113, 2021 01 04.
Article in English | MEDLINE | ID: covidwho-1007629
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Enzyme-Linked Immunosorbent Assay / COVID-19 Testing / SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Diagnostic study / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Nat Commun Journal subject: Biology / Science Year: 2021 Document Type: Article Affiliation country: S41467-020-20383-x

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Enzyme-Linked Immunosorbent Assay / COVID-19 Testing / SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Diagnostic study / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Nat Commun Journal subject: Biology / Science Year: 2021 Document Type: Article Affiliation country: S41467-020-20383-x