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

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.

Dynamics of SARS-CoV-2 seroassay sensitivity: a systematic review and modeling study

“…But although it is common knowledge in the field that accounting for seroreversion is important, there is a lack of appropriate data and guidelines to correct for this phenomenon. This has led to very few studies correcting for seroreversion, and to seemingly conflicting reports in the literature regarding this phenomenon (1,15,16,19,30,31). Also, the high variability in seroreversion between assays, together with the lack of robust assay-specific estimates, make it uncertain how accurate existing adjustments for seroreversion are.…”

“…Although it is known that accounting for seroreversion in these estimates is important, there is a lack of appropriate data and guidelines to do so. Few studies correct for seroreversion (1,16,17,20,30,35), and the lack of robust assay-specific estimates of seroreversion make it uncertain how accurate existing adjustments are. In this work, we present the first large-scale systematic analysis of seroreversion across dozens of seroassays for SARS-CoV-2, making three major contributions to help understand seroreversion and establish guidelines to account for it.…”

Rapid Generation of In-House Serological Assays Is Comparable to Commercial Kits Critical for Early Response to Pandemics: A Case With SARS-CoV-2

“…Indeed, the NIBSC references used in this study were a first attempt at standardization. Equal references are available now by the US National Cancer Institute (NCI) Serological Sciences Network (SeroNet) and the WHO standard 20/136 (replacing the here used NIBSC standard 20/130) (25). Due to the delay in establishing the WHO standard and sample availability in our cohort we were not able to evaluate our in-house assays with the new WHO standard.…”