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

项目摘要 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， 在美国的23 - 25个社区进行：SARS-CoV-2血清阳性率研究（COVID-19 Prevention Trials Network [CoVPN] 5002）. CoVPN 5002研究将包括收集数据和样本 多达98，000人，包括住在养老院和辅助生活设施的人， 在诊所就诊的人和生活在学习社区的人。该研究将包括儿童（2个月大， 老年人和成年人。参与者将使用SARS-CoV-2 RNA检测法进行真实的COVID-19检测。 将使用所有受试者的储存标本，采用敏感的 和特异性SARS-CoV-2 IgG检测（Abbott ARCHITECT COVID-19 IgG检测）。一组标本来自 CoVPN 5002还将用于评价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）。这些样品类型的收集更简单， 比采集鼻拭子或通过放血采集血液样本侵入性更小。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。这将包括使用大量的 多重抗体谱分析（CoronaScan），用于测量抗体与SARS-CoV-2肽的结合 跨越病毒基因组。该分析将提供关于抗体反应的精细特异性的信息 对SARS-CoV-2以及对其他冠状病毒和其他导致呼吸道疾病的病毒的反应性。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检测。具有SARS-CoV-2刺突蛋白抗体的标本（使用 CoronaScan测定）将使用表型重组病毒中和测定进一步评估 （PhenoSense抗SARS-CoV-2中和抗体测定）。这种分析可以识别病毒表位 与病毒中和相关，还可以识别与病毒中和相关的人口统计学和临床因素。 存在中和抗体。来自CoVPN 5002的样本也将用于进一步开发， 评价一种不需要RNA的新型大规模多重病原体检测测定法cRASL-Seq 萃取这项研究的结果将为SARS-CoV-2预防的临床试验设计提供信息， 通过提供不同地理区域COVID-19血清阳性率的信息进行治疗， 参与者群体，包括无症状和有症状的个人，儿童和成人一般 人口和成年人的COVID-19风险增加。

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.