LC: HIV Prevention Trials Network - Laboratory Support for the SARS-CoV-2 Seroprevalence Study (CoVPN 5002)

LC：HIV 预防试验网络 - SARS-CoV-2 血清阳性率研究的实验室支持 (CoVPN 5002)

• 批准号: 10229087
• 负责人: SUSAN H ESHLEMAN
• 金额: $ 16.71万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-21 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10229087
• 关键词: 2019-nCoV; Address; Adult; African American; Age; Antibodies; Antibody Response; Antibody Specificity; Assisted Living Facilities; Binding; Biological Assay; Blood; Blood specimen; COVID-19; COVID-19 pandemic; Child; Chronic Kidney Failure; Chronic Obstructive Airway Disease; Cities; Clinic; Clinical; Clinical Trials Design; Cohort Studies; Collection; Communities; Coronavirus; Country; Data; Data Collection; Detection; Development; Diabetes Mellitus; Diagnosis; Diagnostic; Diagnostic tests; Disease; Elderly; Epitopes; Evaluation; Future; General Population; Genotype; Geographic Locations; HIV prevention trials network; Heart Diseases; Immunoglobulin G; Individual; Infection; Laboratories; Measures; Medical; Methods; Morbidity - disease rate; Nose; Nursing Homes; Obesity; Participant; Pathogen detection; Peptides; Performance; Persons; Phenotype; Play; Populations at Risk; Prevalence; Prevention; Prevention trial; Proteins; Public Health; RNA; Recombinants; Research; Risk; Role; Saliva; Sampling; Serologic tests; Serological; Seroprevalences; Specimen; Spottings; Swab; Technology; Test Result; Testing; United States; Validation; Venous blood sampling; Viral; Viral Genome; Virus; Whole Blood; Work; base; burden of illness; experience; insight; mortality; neutralizing antibody; novel; pandemic disease; pathogen; programs; research study; respiratory; response; sample collection; time use

PROJECT SUMMARY This project will provide laboratory support for a large, cross-sectional COVID-19 seroprevalence study that will be conducted in 23-25 communities in the United States: the SARS-CoV-2 Seroprevalence Study (COVID-19 Prevention Trials Network [CoVPN] 5002). The CoVPN 5002 study will include collection of data and specimens from up to 98,000 persons, including persons living in nursing homes and assisted living facilities, persons attending clinics, and persons living in study communities. The study will include children (ages 2 months and older) and adults. Participants will be tested for COVID-19 in real time using SARS-CoV-2 RNA assays. Seroprevalence will be assessed retrospectively using stored specimens from all participants using a sensitive and specific SARS-CoV-2 IgG assay (Abbott ARCHITECT COVID-19 IgG test). A subset of specimens from CoVPN 5002 will also be used to evaluate the performance of diagnostic and serologic SARS-CoV-2 assays using alternate specimen types (saliva and dried blood spots). Collection of these sample types is simpler and less invasive than collection of nasal swabs or collection of blood samples by phlebotomy. This project will also use of specialized assays to evaluate the serologic response to SARS-CoV-2. This will include use of a massively multiplexed antibody profiling assay (CoronaScan) to measure antibody binding to SARS-CoV-2 peptides spanning the viral genome. This analysis will provide information on the fine specificity of the antibody response to SARS-CoV-2 and reactivity to other coronaviruses and other viruses that cause respiratory illnesses. This testing may also identify participants who have false positive or false negative test results using the ARCHITECT COVID-19 IgG test. Specimens that have antibodies to the SARS-CoV-2 spike protein (identified using the CoronaScan assay) will be further assessed using a phenotypic recombinant viral neutralization assay (PhenoSense Anti-SARS-CoV-2 Neutralizing Antibody Assay). This analysis may identify viral epitopes associated with viral neutralization and may also identify demographic and clinical factors associated with the presence of neutralizing antibodies. Specimens from CoVPN 5002 will also be used for further development and evaluation of a novel, massively multiplexed pathogen detection assay, cRASL-Seq, that does not require RNA extraction. Findings from this research will inform the design of clinical trials for SARS-CoV-2 prevention and treatment by providing information about the seroprevalence of COVID-19 in diverse geographic regions and participants groups, including asymptomatic and symptomatic individuals, children and adults in the general population, and adults at increased risk for COVID-19.

项目概要 该项目将为一项大型横断面 COVID-19 血清阳性率研究提供实验室支持，该研究将 在美国 23-25 个社区进行：SARS-CoV-2 血清阳性率研究 (COVID-19 预防试验网络 [CoVPN] 5002）。 CoVPN 5002 研究将包括数据和样本的收集 多达 98,000 人，包括住在疗养院和辅助生活设施中的人、 就诊的人以及居住在研究社区的人。该研究将包括儿童（2 个月大和 老年人）和成人。将使用 SARS-CoV-2 RNA 检测对参与者进行实时 COVID-19 检测。 将使用所有参与者的储存样本，使用敏感的方法对血清阳性率进行回顾性评估。 和特异性 SARS-CoV-2 IgG 检测（Abbott ARCHITECT COVID-19 IgG 检测）。样本的子集来自 CoVPN 5002 还将用于评估 SARS-CoV-2 诊断和血清学检测的性能 使用替代样本类型（唾液和干血斑）。这些样本类型的收集更加简单 比通过放血采集鼻拭子或采集血样的侵入性更小。该项目还将 使用专门的检测方法来评估对 SARS-CoV-2 的血清学反应。这将包括使用大规模 多重抗体分析测定 (CoronaScan) 用于测量抗体与 SARS-CoV-2 肽的结合 跨越病毒基因组。该分析将提供有关抗体反应的精细特异性的信息 对 SARS-CoV-2 的反应以及对其他冠状病毒和其他引起呼吸道疾病的病毒的反应。这 测试还可以使用 ARCHITECT 识别具有假阳性或假阴性测试结果的参与者 COVID-19 IgG 测试。具有 SARS-CoV-2 刺突蛋白抗体的样本（使用 CoronaScan 检测）将使用表型重组病毒中和检测进行进一步评估 （PhenoSense 抗 SARS-CoV-2 中和抗体测定）。该分析可以识别病毒表位 与病毒中和相关，还可以识别与病毒相关的人口统计和临床因素 中和抗体的存在。 CoVPN 5002 的样本也将用于进一步的开发和 评估一种不需要 RNA 的新型大规模多重病原体检测方法 cRASL-Seq 萃取。这项研究的结果将为 SARS-CoV-2 预防和临床试验的设计提供参考。 通过提供有关不同地理区域的 COVID-19 血清阳性率的信息来进行治疗， 参与者群体，包括无症状和有症状的个人、儿童和成人 人群以及感染 COVID-19 风险较高的成年人。