mSphere (Aug 2022)
The Serological Sciences Network (SeroNet) for COVID-19: Depth and Breadth of Serology Assays and Plans for Assay Harmonization
- Amy B. Karger,
- James D. Brien,
- Jayne M. Christen,
- Santosh Dhakal,
- Troy J. Kemp,
- Sabra L. Klein,
- Ligia A. Pinto,
- Lakshmanane Premkumar,
- John D. Roback,
- Raquel A. Binder,
- Karl W. Boehme,
- Suresh Boppana,
- Carlos Cordon-Cardo,
- James M. Crawford,
- John L. Daiss,
- Alan P. Dupuis,
- Ana M. Espino,
- Adolfo Firpo-Betancourt,
- Catherine Forconi,
- J. Craig Forrest,
- Roxie C. Girardin,
- Douglas A. Granger,
- Steve W. Granger,
- Natalie S. Haddad,
- Christopher D. Heaney,
- Danielle T. Hunt,
- Joshua L. Kennedy,
- Christopher L. King,
- Florian Krammer,
- Kate Kruczynski,
- Joshua LaBaer,
- F. Eun-Hyung Lee,
- William T. Lee,
- Shan-Lu Liu,
- Gerard Lozanski,
- Todd Lucas,
- Damodara Rao Mendu,
- Ann M. Moormann,
- Vel Murugan,
- Nkemakonam C. Okoye,
- Petraleigh Pantoja,
- Anne F. Payne,
- Jin Park,
- Swetha Pinninti,
- Amelia K. Pinto,
- Nora Pisanic,
- Ji Qiu,
- Carlos A. Sariol,
- Viviana Simon,
- Lusheng Song,
- Tara L. Steffen,
- E. Taylor Stone,
- Linda M. Styer,
- Mehul S. Suthar,
- Stefani N. Thomas,
- Bharat Thyagarajan,
- Ania Wajnberg,
- Jennifer L. Yates,
- Kimia Sobhani
Affiliations
- Amy B. Karger
- Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota, USA
- James D. Brien
- Department of Molecular Microbiology & Immunology, Saint Louis University, St. Louis, Missouri, USA
- Jayne M. Christen
- Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA
- Santosh Dhakal
- W. Harry Feinstone Department of Molecular Microbiology and Immunology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
- Troy J. Kemp
- Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA
- Sabra L. Klein
- W. Harry Feinstone Department of Molecular Microbiology and Immunology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
- Ligia A. Pinto
- Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA
- Lakshmanane Premkumar
- Department of Microbiology and Immunology, University of North Carolina, Chapel Hill, North Carolina, USA
- John D. Roback
- Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, Georgia, USA
- Raquel A. Binder
- Department of Medicine, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA
- Karl W. Boehme
- Department of Microbiology & Immunology, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA
- Suresh Boppana
- Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA
- Carlos Cordon-Cardo
- Department of Pathology, Icahn School of Medicine at Mount Sinai, New York, New York, USA
- James M. Crawford
- Department of Pathology and Laboratory Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA
- John L. Daiss
- MicroB-plex, Inc., Atlanta, Georgia, USA
- Alan P. Dupuis
- Wadsworth Center, New York State Department of Health, Albany, New York, USA
- Ana M. Espino
- Department of Microbiology and Medical Zoology, University of Puerto Rico—Medical Sciences Campus, San Juan, Puerto Rico, USA
- Adolfo Firpo-Betancourt
- Department of Pathology, Icahn School of Medicine at Mount Sinai, New York, New York, USA
- Catherine Forconi
- Department of Medicine, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA
- J. Craig Forrest
- Department of Microbiology & Immunology, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA
- Roxie C. Girardin
- Wadsworth Center, New York State Department of Health, Albany, New York, USA
- Douglas A. Granger
- Salimetrics, LLC, Carlsbad, California, USA
- Steve W. Granger
- Salimetrics, LLC, Carlsbad, California, USA
- Natalie S. Haddad
- Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Department of Medicine, Emory University, Atlanta, Georgia, USA
- Christopher D. Heaney
- Department of Environmental Health and Engineering, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
- Danielle T. Hunt
- Wadsworth Center, New York State Department of Health, Albany, New York, USA
- Joshua L. Kennedy
- Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA
- Christopher L. King
- Department of Pathology, Case Western Reserve School of Medicine, Cleveland, Ohio, USA
- Florian Krammer
- Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, New York, USA
- Kate Kruczynski
- Department of Environmental Health and Engineering, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
- Joshua LaBaer
- Virginia G. Piper Center for Personalized Diagnostics, Arizona State University Biodesign Institute, Tempe, Arizona, USA
- F. Eun-Hyung Lee
- Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Department of Medicine, Emory University, Atlanta, Georgia, USA
- William T. Lee
- Wadsworth Center, New York State Department of Health, Albany, New York, USA
- Shan-Lu Liu
- Center for Retrovirus Research, The Ohio State University, Columbus, Ohio, USA
- Gerard Lozanski
- Department of Pathology, The Ohio State University Medical Center, Columbus, Ohio, USA
- Todd Lucas
- Division of Public Health, College of Human Medicine, Michigan State University, East Lansing, Michigan, USA
- Damodara Rao Mendu
- Department of Pathology, Icahn School of Medicine at Mount Sinai, New York, New York, USA
- Ann M. Moormann
- Department of Medicine, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA
- Vel Murugan
- Virginia G. Piper Center for Personalized Diagnostics, Arizona State University Biodesign Institute, Tempe, Arizona, USA
- Nkemakonam C. Okoye
- Department of Pathology and Laboratory Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA
- Petraleigh Pantoja
- Unit of Comparative Medicine, University of Puerto Rico—Medical Sciences Campus, San Juan, Puerto Rico, USA
- Anne F. Payne
- Wadsworth Center, New York State Department of Health, Albany, New York, USA
- Jin Park
- Virginia G. Piper Center for Personalized Diagnostics, Arizona State University Biodesign Institute, Tempe, Arizona, USA
- Swetha Pinninti
- Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA
- Amelia K. Pinto
- Department of Molecular Microbiology & Immunology, Saint Louis University, St. Louis, Missouri, USA
- Nora Pisanic
- Department of Environmental Health and Engineering, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
- Ji Qiu
- Virginia G. Piper Center for Personalized Diagnostics, Arizona State University Biodesign Institute, Tempe, Arizona, USA
- Carlos A. Sariol
- Unit of Comparative Medicine, University of Puerto Rico—Medical Sciences Campus, San Juan, Puerto Rico, USA
- Viviana Simon
- Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, New York, USA
- Lusheng Song
- Virginia G. Piper Center for Personalized Diagnostics, Arizona State University Biodesign Institute, Tempe, Arizona, USA
- Tara L. Steffen
- Department of Molecular Microbiology & Immunology, Saint Louis University, St. Louis, Missouri, USA
- E. Taylor Stone
- Department of Molecular Microbiology & Immunology, Saint Louis University, St. Louis, Missouri, USA
- Linda M. Styer
- Wadsworth Center, New York State Department of Health, Albany, New York, USA
- Mehul S. Suthar
- Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta, Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA
- Stefani N. Thomas
- Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota, USA
- Bharat Thyagarajan
- Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota, USA
- Ania Wajnberg
- Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA
- Jennifer L. Yates
- Wadsworth Center, New York State Department of Health, Albany, New York, USA
- Kimia Sobhani
- Department of Pathology and Laboratory Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USA
- DOI
- https://doi.org/10.1128/msphere.00193-22
- Journal volume & issue
-
Vol. 7,
no. 4
Abstract
ABSTRACT In October 2020, the National Cancer Institute (NCI) Serological Sciences Network (SeroNet) was established to study the immune response to COVID-19, and “to develop, validate, improve, and implement serological testing and associated technologies” (https://www.cancer.gov/research/key-initiatives/covid-19/coronavirus-research-initiatives/serological-sciences-network). SeroNet is comprised of 25 participating research institutions partnering with the Frederick National Laboratory for Cancer Research (FNLCR) and the SeroNet Coordinating Center. Since its inception, SeroNet has supported collaborative development and sharing of COVID-19 serological assay procedures and has set forth plans for assay harmonization. To facilitate collaboration and procedure sharing, a detailed survey was sent to collate comprehensive assay details and performance metrics on COVID-19 serological assays within SeroNet. In addition, FNLCR established a protocol to calibrate SeroNet serological assays to reference standards, such as the U.S. severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serology standard reference material and first WHO international standard (IS) for anti-SARS-CoV-2 immunoglobulin (20/136), to facilitate harmonization of assay reporting units and cross-comparison of study data. SeroNet institutions reported development of a total of 27 enzyme-linked immunosorbent assay (ELISA) methods, 13 multiplex assays, and 9 neutralization assays and use of 12 different commercial serological methods. FNLCR developed a standardized protocol for SeroNet institutions to calibrate these diverse serological assays to reference standards. In conclusion, SeroNet institutions have established a diverse array of COVID-19 serological assays to study the immune response to SARS-CoV-2 and vaccines. Calibration of SeroNet serological assays to harmonize results reporting will facilitate future pooled data analyses and study cross-comparisons. IMPORTANCE SeroNet institutions have developed or implemented 61 diverse COVID-19 serological assays and are collaboratively working to harmonize these assays using reference materials to establish standardized reporting units. This will facilitate clinical interpretation of serology results and cross-comparison of research data.
Keywords
