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[Preprint]. 2022 Mar 14:2022.02.27.22271399.

doi: 10.1101/2022.02.27.22271399.

The Serological Sciences Network (SeroNet) for COVID-19: Depth and Breadth of Serology Assays and Plans for Assay Harmonization

Amy B Karger¹, James D Brien², Jayne M Christen³, Santosh Dhakal⁴, Troy J Kemp³, Sabra L Klein⁴, Ligia A Pinto³, Lakshmanane Premkumar⁵, John D Roback⁶, Raquel A Binder⁷, Karl W Boehme⁸, Suresh Boppana^{9

10}, Carlos Cordon-Cardo¹¹, James M Crawford¹², John L Daiss¹³, Alan P Dupuis 2nd¹⁴, Ana M Espino¹⁵, Adolfo Firpo-Betancourt¹¹, Catherine Forconi⁷, J Craig Forrest⁸, Roxie C Girardin¹⁴, Douglas A Granger¹⁶, Steve W Granger¹⁶, Natalie S Haddad¹⁷, Christopher D Heaney¹⁸, Danielle T Hunt¹⁴, Joshua L Kennedy^{19

20}, Christopher L King²¹, Florian Krammer²², Kate Kruczynski¹⁸, Joshua LaBaer²³, F Eun-Hyung Lee¹⁷, William T Lee^{14

24}, Shan-Lu Liu²⁵, Gerard Lozanski²⁶, Todd Lucas²⁷, Damodara Rao Mendu¹¹, Ann M Moormann⁷, Vel Murugan²³, Nkemakonam C Okoye¹², Petraleigh Pantoja²⁸, Anne F Payne¹⁴, Jin Park²³, Swetha Pinninti⁹, Amelia K Pinto², Nora Pisanic¹⁸, Ji Qiu²³, Carlos A Sariol^{28

29}, Viviana Simon²², Lusheng Song²³, Tara L Steffen², E Taylor Stone², Linda M Styer^{14

24}, Mehul S Suthar³⁰, Stefani N Thomas¹, Bharat Thyagarajan¹, Ania Wajnberg³¹, Jennifer L Yates^{14

24}, Kimia Sobhani³²

Affiliations

¹ Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota.
² Department of Molecular Microbiology & Immunology, Saint Louis University, Saint Louis, Missouri.
³ Frederick National Laboratory for Cancer Research, Frederick, Maryland.
⁴ W. Harry Feinstone Department of Molecular Microbiology and Immunology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
⁵ Department of Microbiology and Immunology, University of North Carolina, Chapel Hill, NC.
⁶ Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, Georgia.
⁷ Department of Medicine, University of Massachusetts Chan Medical School, Worcester, Massachusetts.
⁸ Department of Microbiology & Immunology, University of Arkansas for Medical Sciences, Little Rock, Arkansas.
⁹ Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama.
¹⁰ Department of Microbiology, University of Alabama at Birmingham, Birmingham, Alabama.
¹¹ Department of Pathology, Icahn School of Medicine at Mount Sinai, New York, New York.
¹² Department of Pathology and Laboratory Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York.
¹³ MicroB-plex, Inc., Atlanta, Georgia.
¹⁴ Wadsworth Center, New York State Department of Health, Albany, New York.
¹⁵ Department of Microbiology and Medical Zoology, University of Puerto Rico-Medical Sciences Campus, San Juan, Puerto Rico.
¹⁶ Salimetrics, LLC, Carlsbad, California.
¹⁷ Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Department of Medicine, Emory University, Atlanta, Georgia.
¹⁸ Department of Environmental Health and Engineering, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
¹⁹ Departments of Pediatrics and Internal Medicine, University of Arkansas for Medical Sciences, Little Rock, Arkansas.
²⁰ Arkansas Children's Research Institute, Little Rock, Arkansas.
²¹ Department of Pathology, Case Western Reserve School of Medicine, Cleveland, Ohio.
²² Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, New York.
²³ Virginia G Piper Center for Personalized Diagnostics, Arizona State University Biodesign Institute, Tempe, Arizona.
²⁴ Department of Biomedical Sciences, School of Public Health, University at Albany, Albany, New York.
²⁵ Center for Retrovirus Research, Department of Veterinary Biosciences, Department of Microbial Infection and Immunity, Viruses and Emerging Pathogens Program, Infectious Disease Institute, The Ohio State University, Columbus, Ohio.
²⁶ Department of Pathology, The Ohio State University Medical Center, Columbus, Ohio.
²⁷ Division of Public Health and Department of Epidemiology, College of Human Medicine, Michigan State University, East Lansing, Michigan.
²⁸ Unit of Comparative Medicine, University of Puerto Rico-Medical Sciences Campus, San Juan, Puerto Rico.
²⁹ Department of Internal Medicine, University of Puerto Rico-Medical Sciences Campus, San Juan, Puerto Rico.
³⁰ Center for Childhood Infections and Vaccines of Children's Healthcare Atlanta, Department of Pediatrics, Department of Microbiology and Immunology, Emory Vaccine Center, Yerkes National Primate Research Center, Emory University School of Medicine, Atlanta, Georgia.
³¹ Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.
³² Department of Pathology and Laboratory Medicine, Cedars-Sinai Medical Center, Los Angeles, California.

PMID: 35262095
PMCID: PMC8902887
DOI: 10.1101/2022.02.27.22271399

The Serological Sciences Network (SeroNet) for COVID-19: Depth and Breadth of Serology Assays and Plans for Assay Harmonization

Amy B Karger et al. medRxiv. 2022.

[Preprint]. 2022 Mar 14:2022.02.27.22271399.

doi: 10.1101/2022.02.27.22271399.

Authors

Affiliations

¹ Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota.
² Department of Molecular Microbiology & Immunology, Saint Louis University, Saint Louis, Missouri.
³ Frederick National Laboratory for Cancer Research, Frederick, Maryland.
⁴ W. Harry Feinstone Department of Molecular Microbiology and Immunology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
⁵ Department of Microbiology and Immunology, University of North Carolina, Chapel Hill, NC.
⁶ Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, Georgia.
⁷ Department of Medicine, University of Massachusetts Chan Medical School, Worcester, Massachusetts.
⁸ Department of Microbiology & Immunology, University of Arkansas for Medical Sciences, Little Rock, Arkansas.
⁹ Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama.
¹⁰ Department of Microbiology, University of Alabama at Birmingham, Birmingham, Alabama.
¹¹ Department of Pathology, Icahn School of Medicine at Mount Sinai, New York, New York.
¹² Department of Pathology and Laboratory Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York.
¹³ MicroB-plex, Inc., Atlanta, Georgia.
¹⁴ Wadsworth Center, New York State Department of Health, Albany, New York.
¹⁵ Department of Microbiology and Medical Zoology, University of Puerto Rico-Medical Sciences Campus, San Juan, Puerto Rico.
¹⁶ Salimetrics, LLC, Carlsbad, California.
¹⁷ Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Department of Medicine, Emory University, Atlanta, Georgia.
¹⁸ Department of Environmental Health and Engineering, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
¹⁹ Departments of Pediatrics and Internal Medicine, University of Arkansas for Medical Sciences, Little Rock, Arkansas.
²⁰ Arkansas Children's Research Institute, Little Rock, Arkansas.
²¹ Department of Pathology, Case Western Reserve School of Medicine, Cleveland, Ohio.
²² Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, New York.
²³ Virginia G Piper Center for Personalized Diagnostics, Arizona State University Biodesign Institute, Tempe, Arizona.
²⁴ Department of Biomedical Sciences, School of Public Health, University at Albany, Albany, New York.
²⁵ Center for Retrovirus Research, Department of Veterinary Biosciences, Department of Microbial Infection and Immunity, Viruses and Emerging Pathogens Program, Infectious Disease Institute, The Ohio State University, Columbus, Ohio.
²⁶ Department of Pathology, The Ohio State University Medical Center, Columbus, Ohio.
²⁷ Division of Public Health and Department of Epidemiology, College of Human Medicine, Michigan State University, East Lansing, Michigan.
²⁸ Unit of Comparative Medicine, University of Puerto Rico-Medical Sciences Campus, San Juan, Puerto Rico.
²⁹ Department of Internal Medicine, University of Puerto Rico-Medical Sciences Campus, San Juan, Puerto Rico.
³⁰ Center for Childhood Infections and Vaccines of Children's Healthcare Atlanta, Department of Pediatrics, Department of Microbiology and Immunology, Emory Vaccine Center, Yerkes National Primate Research Center, Emory University School of Medicine, Atlanta, Georgia.
³¹ Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.
³² Department of Pathology and Laboratory Medicine, Cedars-Sinai Medical Center, Los Angeles, California.

PMID: 35262095
PMCID: PMC8902887
DOI: 10.1101/2022.02.27.22271399

Update in

The Serological Sciences Network (SeroNet) for COVID-19: Depth and Breadth of Serology Assays and Plans for Assay Harmonization.
Karger AB, Brien JD, Christen JM, Dhakal S, Kemp TJ, Klein SL, Pinto LA, Premkumar L, Roback JD, Binder RA, Boehme KW, Boppana S, Cordon-Cardo C, Crawford JM, Daiss JL, Dupuis AP 2nd, Espino AM, Firpo-Betancourt A, Forconi C, Forrest JC, Girardin RC, Granger DA, Granger SW, Haddad NS, Heaney CD, Hunt DT, Kennedy JL, King CL, Krammer F, Kruczynski K, LaBaer J, Lee FE, Lee WT, Liu SL, Lozanski G, Lucas T, Mendu DR, Moormann AM, Murugan V, Okoye NC, Pantoja P, Payne AF, Park J, Pinninti S, Pinto AK, Pisanic N, Qiu J, Sariol CA, Simon V, Song L, Steffen TL, Stone ET, Styer LM, Suthar MS, Thomas SN, Thyagarajan B, Wajnberg A, Yates JL, Sobhani K. Karger AB, et al. mSphere. 2022 Aug 31;7(4):e0019322. doi: 10.1128/msphere.00193-22. Epub 2022 Jun 15. mSphere. 2022. PMID: 35703544 Free PMC article.

Abstract

Background: 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." 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.

Methods: 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. 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.

Results: SeroNet institutions reported development of a total of 27 ELISA methods, 13 multiplex assays, 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.

Conclusions: SeroNet institutions have established a diverse array of COVID-19 serological assays to study the immune response to SARS-CoV-2 virus and vaccines. Calibration of SeroNet serological assays to harmonize results reporting will facilitate future pooled data analyses and study cross-comparisons.

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Figures

**Figure 1:**
Example plate map for assay calibration set-up Numbers indicate suggested serial dilutions. Serial dilutions of primary and secondary calibrators (reference materials) are plated in triplicate, and the daily internal assay standard is plated in quadruplicate. C_STD: Daily internal assay standard STD-C1, C2, and C3: Primary calibrator (primary reference material or standard) STD-T1, T2, and T3: Secondary calibrator (secondary reference material or standard) NEG: Negative control sample PC1: Positive control sample 1 PC2: Positive control sample 2

See this image and copyright information in PMC

References

1. NCI Serological Sciences Network for COVID-19 (SeroNet). Accessed December 2, 2021. https://www.cancer.gov/research/key-initiatives/covid-19/coronavirus-res...
1. In Vitro Diagnostics EUAs - Serology and Other Adaptive Immune Response Tests for SARS-CoV-2. Food and Drug Administration (FDA). Accessed December 2, 2021. https://www.fda.gov/medicaldevices/coronavirus-disease-2019-covid-19-eme...
1. Muecksch F, Wise H, Batchelor B, et al. Longitudinal Serological Analysis and Neutralizing Antibody Levels in Coronavirus Disease 2019 Convalescent Patients. J Infect Dis. 02 13 2021;223(3):389–398. doi: 10.1093/infdis/jiaa659 - DOI - PMC - PubMed
1. Perez-Saez J, Zaballa ME, Yerly S, et al. Persistence of anti-SARS-CoV-2 antibodies: immunoassay heterogeneity and implications for serosurveillance. Clin Microbiol Infect. Nov 2021;27(11):1695.e7–1695.e12. doi: 10.1016/j.cmi.2021.06.040 - DOI - PMC - PubMed
1. Muecksch F, Wise H, Templeton K, et al. Longitudinal variation in SARS-CoV-2 antibody levels and emergence of viral variants: implications for the ability of serological assays to predict immunity. medRxiv. Jul 07 2021;doi: 10.1101/2021.07.02.21259939 - DOI - PMC - PubMed

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This is a preprint.

The Serological Sciences Network (SeroNet) for COVID-19: Depth and Breadth of Serology Assays and Plans for Assay Harmonization

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The Serological Sciences Network (SeroNet) for COVID-19: Depth and Breadth of Serology Assays and Plans for Assay Harmonization

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Abstract

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