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

Abstract

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.

SARS-CoV-2 Antibody Prevalence among Industrial Livestock Operation Workers and Nearby Community Residents, North Carolina, 2021 to 2022

“…This waning, especially of N-specific antibodies, may have caused us to underestimate infection-induced SARS-CoV-2 exposure. Variability in commercial anti-N antibody assay performance suggests faster waning of N-specific antibodies may be related to assay characteristics rather than biological waning ( 46 – 48 ). We used a quantitative antibody assay, which generally perform better than lateral flow assays ( 48 ).…”

Development, Validation, and Utilization of a Luminex-Based SARS-CoV-2 Multiplex Serology Assay

“…Sensitivity or positive predictive agreement (PPA) is the proportion of subjects with the target condition in whom the test is positive. Specificity, or negative predictive agreement (NPA), is the proportion of subjects without the target condition in whom the test is negative ( 6 ).…”

“… a Shown here are sensitivity and specificity estimates and the ratio of responsive samples for PPA and NPA, calculated using the Wilson score method. Positive predictive value (PPV) and negative predictive value (NPV) were estimated using combined PPA and combined NPA, respectively ( 6 ). The assay cutoff concentrations for each protein were determined based on the mean concentration plus five standard deviations of 160 serum or plasma samples collected prior to the pandemic, prior December 2019 and thus, presumably unexposed and SARS-CoV-2 seronegative by other assays, such as ELISAs.…”

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

“…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 (1,15,16,29,36,37), and the lack of robust assay-specific seroreversion estimates make it uncertain how accurate existing adjustments are. 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 and correct for seroreversion.…”