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

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. <strong>IMPORTANCE</strong> 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.

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UNC Libraries
Published
2025-04-17
DOI
https://doi.org/10.17615/cx3j-2776
Primary Topic
SARS-CoV-2 and COVID-19 Research
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article
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article

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

Karl W. Boehme, John L. Daiss, James M. Crawford, Jennifer L. Yates et al.
UNC Libraries
SARS-CoV-2 and COVID-19 Research
article

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

Karl W. Boehme, John L. Daiss, James M. Crawford, Jennifer L. Yates, Nkemakonam C. Okoye, Vel Murugan, Lusheng Song, Suresh B. Boppana, Todd Lucas, J. Craig Forrest, Gerard Lozanski, F. Eun‐Hyung Lee, Petraleigh Pantoja, Roxie C. Girardin, Steve W. Granger, Christopher D. Heaney, Santosh Dhakal, Ana M. Espino, Jayne M. Christen, Natalie S. Haddad, Mehul S. Suthar, Nora Pisanic, Christopher L. King, Sabra L. Klein, Tara L. Steffen, William T. Lee, Alan P. Dupuis, Amelia K. Pinto, Kate Kruczynski, Swetha Pinninti, Amy B. Karger, Joshua LaBaer, Ania Wajnberg, Raquel A. Binder, John D. Roback, Stefani N. Thomas, Danielle Hunt, Lígia A. Pinto, Catherine S. Forconi, Ji Qiu, Shan‐Lu Liu, Lakshmanane Premkumar, Bharat Thyagarajan, James D. Brien, Adolfo Firpo‐Betancourt, Troy J. Kemp, Linda M. Styer, Damodara Rao Mendu, Florian Krammer, Douglas Alan Granger, Ann M. Moormann, Joshua L. Kennedy, E. Taylor Stone, Kimia Sobhani, Carlos Cordon‐Cardo, Carlos A. Sariol, Jin Park, Viviana Simon, Anne F. Payne
article en

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. <strong>IMPORTANCE</strong> 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.

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SARS-CoV-2 and COVID-19 Research
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