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

该项目将为将在美国15个社区进行的大型横断面新冠肺炎血清抗体研究提供实验室支持：SARS-CoV-2血清抗体研究(新冠肺炎预防试验网络[CoVPN]5002)。CoVPN 5002研究将收集多达58,800人的数据和样本，包括生活在养老院和辅助生活设施中的人、到诊所就诊的人以及生活在研究社区中的人。这项研究将包括儿童(2个月及以上)和成年人。参与者将使用SARS-CoV-2RNA测试来实时检测新冠肺炎。血清阳性率将使用敏感和特异的SARS-CoV-2免疫球蛋白试验(雅培建筑师新冠肺炎免疫球蛋白试验，检测针对SARS-CoV-2核衣壳蛋白的免疫球蛋白抗体的存在)，对所有参与者的存储样本进行回顾性评估。CoVPN 5002的样本子集也将用于评估使用不同样本类型(唾液和干血点)的诊断和血清学SARS-CoV-2检测的性能。与采集鼻拭子或采集血液样本相比，采集这些类型的样本更简单，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。这可能包括使用大规模多重抗体图谱分析来测量与跨越病毒基因组的SARS-CoV-2多肽结合的抗体。这一分析可能提供有关SARS-CoV-2抗体反应的良好特异性以及对其他冠状病毒和导致呼吸道疾病的其他病毒的反应性的信息。这项测试还可以识别使用建筑师新冠肺炎免疫球蛋白测试的假阳性或假阴性测试结果的参与者。这项研究的结果将通过提供有关新冠肺炎在不同地理地区和参与者群体中的血清阳性率的信息，为SARS-CoV-2预防和治疗的临床试验设计提供参考，这些群体包括无症状和症状的个人、普通人群中的儿童和成人以及患新冠肺炎风险增加的成年人。

This project will provide laboratory support for a large, cross-sectional COVID-19 seroprevalence study that will be conducted in 15 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 58,800 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, which detects the presence of IgG antibodies against the SARS-CoV-2 nucleocapsid protein). 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 may include use of a massively multiplexed antibody profiling assay to measure antibody binding to SARS-CoV-2 peptides spanning the viral genome. This analysis may 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. 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.