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-researchinitiatives/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 language | English |
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Journal | mSphere |
Volume | 7 |
Issue number | 4 |
DOIs | |
State | Published - Aug 2022 |
Bibliographical note
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.
Funding
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.). 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).
Funders | Funder number |
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Be Biopharma, Inc. | |
National Childhood Cancer Registry – National Cancer Institute | 21X091, 75N91021F00001, 21X090, 75N91019D00024, U01CA260541, U01CA260462, U01CA261276, U01CA260469, U01CA260539, U01CA260526, 21X089, U54CA260543, U01CA260508, U54CA260563, U54CA260582, U54CA260492, U54CA260591, 21X092 |
National Childhood Cancer Registry – National Cancer Institute | |
Bill and Melinda Gates Foundation | |
Genentech Incorporated | |
plasma cell survival media |
Keywords
- COVID-19
- SeroNet
- assay harmonization
- serology
ASJC Scopus subject areas
- Microbiology
- Molecular Biology