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

PROJECT Summary: This project will provide laboratory support for a large, cross-sectional COVID-19 seroprevalence study that willbe conducted in 23-25 communities in the United States: the SARS-CoV-2 Seroprevalence Study (COVID-19Prevention Trials Network [CoVPN] 5002). The CoVPN 5002 study will include collection of data and specimensfrom up to 98,000 persons, including persons living in nursing homes and assisted living facilities, personsattending clinics, and persons living in study communities. The study will include children (ages 2 months andolder) 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 sensitiveand specific SARS-CoV-2 IgG assay (Abbott ARCHITECT COVID-19 IgG test). A subset of specimens fromCoVPN 5002 will also be used to evaluate the performance of diagnostic and serologic SARS-CoV-2 assaysusing alternate specimen types (saliva and dried blood spots). Collection of these sample types is simpler andless invasive than collection of nasal swabs or collection of blood samples by phlebotomy. This project will alsouse of specialized assays to evaluate the serologic response to SARS-CoV-2. This will include use of a massivelymultiplexed antibody profiling assay (CoronaScan) to measure antibody binding to SARS-CoV-2 peptidesspanning the viral genome. This analysis will provide information on the fine specificity of the antibody responseto SARS-CoV-2 and reactivity to other coronaviruses and other viruses that cause respiratory illnesses. Thistesting may also identify participants who have false positive or false negative test results using the ARCHITECTCOVID-19 IgG test. Specimens that have antibodies to the SARS-CoV-2 spike protein (identified using theCoronaScan 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 epitopesassociated with viral neutralization and may also identify demographic and clinical factors associated with thepresence of neutralizing antibodies. Specimens from CoVPN 5002 will also be used for further development andevaluation of a novel, massively multiplexed pathogen detection assay, cRASL-Seq, that does not require RNAextraction. Findings from this research will inform the design of clinical trials for SARS-CoV-2 prevention andtreatment by providing information about the seroprevalence of COVID-19 in diverse geographic regions andparticipants groups, including asymptomatic and symptomatic individuals, children and adults in the generalpopulation, and adults at increased risk for COVID-19.