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

弗雷德里克国家癌症研究实验室 (FNLCR) SARS-CoV-2 血清学科学中心

• 批准号: 10582502
• 负责人: ETHAN DMITROVSKY
• 金额: $ 5790.91万
• 依托单位: LEIDOS BIOMEDICAL RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-02-11 至 2026-02-10
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10582502
• 关键词: 2019-nCoV; Antibody Response; Biological Assay; Biological Markers; COVID-19; COVID-19 vaccination; COVID-19 vaccine; Communities; Data; Development; Disease; Enzyme-Linked Immunosorbent Assay; Immune response; Immunity; Immunology; Infection; Laboratories; Malignant Neoplasms; NCI Center for Cancer Research; National Cancer Institute; Natural History; Research; Research Project Grants; SARS-CoV-2 antibody; Sampling; Science; Sensitivity and Specificity; Serology; Serology test; Testing; United States National Institutes of Health; Vaccination; Vaccine Research; Vaccines; Validation; Viral; Virus; antibody test; anticancer research; assay development; base; epidemiology study; lateral flow assay; point of care; programs; response

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.

国家癌症研究所的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灵敏度的血清学检测来研究对COVID-19的免疫反应，扩大SARS-CoV-2抗体的国家检测能力，并进行研究以了解对SARS-CoV-2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（CBC）和（3）协调所有SeroNet组件活动的协调中心组成。该中心对民解力量血清学实验室的优先事项是开发和验证血清学抗体检测，包括ELISA、护理点侧流检测和病毒中和检测。该中心还将制定和传播国家SARS-CoV-2血清学标准，其中包括阳性和阴性对照沿着熟练小组样本。该中心还将在FNLCR疫苗、免疫和癌症（维克）计划和CBC中实施基于实验室的血清学检测，并提高检测通量，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感染保护的相关性。该中心的CBCs将通过将检测范围扩大到每周约1万份样本，并在感染的自然史或接种疫苗后进行研究，以确定对SARS-CoV-2免疫反应的决定因素，来建立血清学检测能力。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。这可能包括开发用于体液应答的不同功能方面的测定，例如假病毒中和测定、抗体应答的决定因素和其他相关疾病生物标志物。来自这些相互合作研究、U 54血清学科学卓越中心和U 01 SARS-CoV-2研究项目的数据将通过中心内的协调中心提供给社区。