Given the emergence of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and the urgent need to mitigate the pathogen’s spread, the Frederick National Laboratory for Cancer Research (FNLCR), in collaboration and with the support from the National Cancer Institute (NCI), has established a new initiative: the Center of Excellence for Serology Development and Emergency Preparedness (CESDEP). CESDEP is tasked with the development of strategies for rapid deployment and expansion of SARS-CoV-2 serological and other immunological testing for public health benefit and pandemic control. The goal of this initiative is to mobilize collaborative efforts to collect large volumes of blood from SARS-CoV-2 infected and/or vaccinated individuals. Some of these collections will be utilized for the development of immunological standards (such as serological antibody standards and assay validation panels), as well as the expansion of high quality national serological testing capability, to address key immunological questions with validated new and existing technologies. The primary endpoint of this work is to set a precedent and build a network capable of biospecimen acquisition and serological testing, comprehensive data collection, standards development, storage as well as distribution to the scientific community (including assay developers and manufacturers). This work will be conducted in partnership with CESDEP members, including the FNLCR Serology Laboratory, to develop and provide high quality reagents, biospecimens, and standards to the serology community. Objectives Deliver to the CESDEP project large volumes of serum, plasma and PBMCs from participants with well clinical evidence of infection and documented vaccination histories who meet the Reference Materials Study acceptance criteria, for the purpose of development of SARS-CoV-2 Evaluation Panels and Serum Standards for acceptance by the FDA, as well as for the research community, including assay developers. Enroll, consent, and maintain participants who meet the Reference Study and Longitudinal Study acceptance criteria. Deliver serum, plasma and PBMC’s from all required timepoints from the same participant so that intra-case analysis can be performed as well as blood for Deoxyribonucleic acid (DNA) extraction from a single timepoint for the purpose of sero-surveillance and genomic, immunologic, and proteomic research, as well as novel technology development. Collect a set of nasal swab biospecimens for the purpose of extracting viral Ribonucleic Acid (RNA) for sequencing from participants with active infection. Test primarily a serum biospecimen from each timepoint, in a Clinical Laboratory Improvements Amendments (CLIA) - certified lab for SARS-CoV-2 S and N IgG. Leidos Biomedical Research, Inc. Point of Contact for a copy of Solicitation/RFP No: S24-006:Tara Phillips at
[email protected].