Frederick National Laboratory for Cancer Research (FNLCR) Center for SARS-CoV-2 Serological Sciences

The purpose of the National Cancer Institute's SARS-CoV-2 Serological Sciences Network (SeroNet) is to study the immune response to COVID-19 by developing and deploying serological assays of the highest specificity and sensitivity, expanding the national testing capacity for SARS-CoV-2 antibodies, and conducting research to develop understanding of immune responses to SARS-CoV-2. The FNLCR Center for SARS-CoV-2 Serological Sciences (the Center) is comprised of (1) Frederick National Laboratory (FNL) Serology Lab, (2) SARS-CoV-2 Serology Capacity Building Centers (CBCs), and (3) a Coordination Center that coordinates the activities of all SeroNet components. The Center's priority for the FNL Serology Lab will be for the development and validation of serological antibody assays, including ELISAs, point of care lateral flow tests, and virus neutralization assays. The Center will also develop and disseminate the National SARS-CoV-2 serology standard that includes positive and negative controls along with proficiency panel samples. The Center will also implement laboratory based serology assays and increase assay throughput capabilities within the FNLCR Vaccine, Immunity and Cancer (VIC) Program and the CBCs for use in viral immunology studies to understand longitudinal responses to natural infection or vaccination and to determine correlates of protection against infection in sero-epidemiology studies with the NIH/NCI and outside community. The Center's CBCs will build serological testing capacity by expanding testing to ~10K samples/week and conducting research in the natural history of infection or following vaccination to identify determinants of the immune response to SARS-CoV-2. The CBCs will also develop new assays as needed for deeper characterization of immune responses to the virus, vaccines, and correlates of protection. This may include development of assays for different functional aspects of the humoral responses, such as pseudovirus neutralization assays, determinants of antibody response and other relevant disease biomarkers. The data from these inter-collaborative studies, the U54 Serological Sciences Centers of Excellence, and U01 Research Projects in SARS-CoV-2 will be made available to the community through the Coordination Center within the Center.