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 ForrestRoxie 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

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)e0019322
JournalmSphere
Volume7
Issue number4
DOIs
StatePublished - Aug 31 2022

Bibliographical note

Funding Information:
This work was funded by NCI contract no. 75N91019D00024, task order no. 75N91021F00001, award numbers 21X089 (J.L., V.M., J.P., J.Q., and L.S.), 21X090 (J.M.C. and N.C.O.), 21X091 (A.B.K., S.N.T., and B.T.), and 21X092 (C.C.-C., A.F.-B., F.K., D.R.M., V.S., and A.W.) and NCI grants U54CA260591 (K.S.), U01CA260469 (T.L., D.A.G., S.W.G., C.D.H., K.K., and N.P.), U54CA260543 (L.P.), U54CA260582 (S.-L.L. and G.L.), U54CA260492 (S.L.K. and S.D.), U54CA260563 (F.E.-H.L., M.S.S., N.S.H., J.L.D., and J.D.R.), U01CA260541 (J.D.B., A.K.P., T.L.S., E.T.S., C.A.S., P.P., and A.M.E.), U01CA260526 (K.W.B., J.C.F., and J.L.K.), U01CA261276 (R.A.B., C.F., and A.M.M.), U01CA260539 (C.L.K.), U01CA260508 (L.M.S., A.P.D., R.C.G., D.T.H., W.T.L., J.L.Y., and A.F.P.), and U01CA260462 (S.B. and S.P.).

Funding Information:
The National Cancer Institute (NCI) Serological Sciences Network for COVID-19 (SeroNet) was launched on 8 October 2020 as a collaborative initiative to expand research on immune responses to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SeroNet is comprised of investigators from 25 U.S. biomedical research institutions, working in partnership with the Frederick National Laboratory for Cancer Research (FNLCR) and the SeroNet Coordinating Center, which is managed by FNLCR (1). Of the 25 participating research institutions, 8 are designated as Serological Sciences Centers of Excellence (funded by U54 grants), 13 are funded with U01 grants to carry out specific research projects related to COVID-19 immunity, and 4 institutions are funded by subcontracts and are designated as Serological Sciences Network Capacity Building Centers (1).

Publisher Copyright:
Copyright © 2022 Karger et al. This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license.

Keywords

  • assay harmonization
  • COVID-19
  • serology
  • SeroNet

PubMed: MeSH publication types

  • Journal Article
  • Research Support, N.I.H., Extramural

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