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

国家癌症研究所SARS-CoV-2血清学科学网络（SeroNet）的目的是通过开发和部署最高特异性和敏感性的血清学分析，扩大国家SARS-CoV-2抗体检测能力，以及开展研究以了解对SARS-CoV-2的免疫反应，研究对COVID-19的免疫反应。FNLCR SARS-CoV-2血清学科学中心（中心）由(1)弗雷德里克国家实验室（FNL）血清学实验室，(2)SARS-CoV-2血清学能力建设中心（CBCs）和(3)协调所有SeroNet组成部分活动的协调中心组成。该中心对FNL血清学实验室的重点将是开发和验证血清学抗体测定，包括elisa、护理点侧流试验和病毒中和测定。中心还将制定和发布国家SARS-CoV-2血清学标准，包括阳性对照和阴性对照以及熟练程度小组样本。该中心还将实施基于实验室的血清学分析，并在FNLCR疫苗、免疫和癌症（VIC）项目和CBCs中提高分析通量能力，用于病毒免疫学研究，以了解对自然感染或疫苗接种的纵向反应，并确定与NIH/NCI和外部社区进行的血清流行病学研究中预防感染的保护的相关性。该中心的血清学检测中心将建立血清学检测能力，将检测范围扩大到每周约1万份样本，并开展感染自然史或接种疫苗后的研究，以确定对SARS-CoV-2免疫反应的决定因素。CBCs还将根据需要开发新的检测方法，以更深入地表征对病毒、疫苗和保护相关物的免疫反应。这可能包括开发针对体液反应不同功能方面的检测方法，如假病毒中和检测、抗体反应决定因素和其他相关疾病生物标志物。这些相互合作研究、U54血清学卓越中心和U01 SARS-CoV-2研究项目的数据将通过中心内的协调中心向社区提供。

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.