Document text
Principal Investigator: Andrew S Neish
Organization: EMORY UNIVERSITY
Fiscal Year: 2024
Award: $88,878
Funding agency: National Cancer Institute
Abstract:
The proposed Immune Monitoring Core (IMC; Core 2) has been designed to provide a unified, comprehensive,
and centralized service to provide the U54 investigators with efficient and reproducible high-throughput analysis
of antibody responses to SARS-CoV-2, including binding, functional characterization, and neutralization activity
(both retained clinical specimens and prospectively collected blood samples from Core 1) in support of the
studies described in Projects 1-3. The IMC is an outgrowth of CLIA certified diagnostic assay platforms
developed by IMC investigators and now in use in the Emory Medical Laboratories (EML), as well as a result of
development of relevant assays in the Translational Research laboratory in the Dept. of Pathology and other
Emory sites. IMC activities will be performed by experimental investigators from oncology, pathology, and
infectious diseases, clinical pathologists, and trained technicians. This group’s efforts will be coordinated through
regular meetings between leadership of the three Projects, Core 1, and the Administrative Core. The IMC
activities will achieve the following Specific Aims:
Aim 1. Employ the high-throughput automated RBD ELISA to perform serosurveillance of cancer and
rheumatology patients treated within Emory Healthcare. The Core will utilize anti-RBD ELISA test
(developed by IMC investigators) now in clinical use, as well variants of this test for detection of IgM and IgA
responses. These assays will be used both for sero-surveillance on retained clinical samples from the target
patient groups, and also on prospectively collected samples, as described in Core 1.
Aim 2. Perform detailed evaluations of antibody response to SARS-CoV-2 in COVID-19 infected patients.
While the automated ELISA will be used to screen all samples for anti-RBD antibodies, prospectively collected
samples from SARS-CoV-2 infected patients will also be tested for antibodies against SARS-CoV-2 spike (S),
nucleocapsid (N), envelope (E) and membrane (M) proteins. Additionally, functional characterization of SARS-
CoV-2 antibodies will include assays of antibody dependent cell-mediated cytotoxicity (ADCC).
Aim 3. Measuring the neutralization activity in COVID-19 infected patients. Prospectively collected samples
from designated patient groups which have SARS-CoV-2 antibodies by ELISA will be tested in the pseudovirus
neutralization assay under BSL2+ conditions. Subsequently, those samples that are positive will be confirmed
using a recently developed focus reduction neutralization titer (FRNT)-mNG assay.
Overall, this Core allows U54 investigators to take advantage of state-of-the-art and diagnostic quality immune
monitoring to achieve Project goals.
Terms: <19S Gamma Globulin><2019 novel corona virus><2019 novel coronavirus><2019-nCoV><2019-nCoV S protein><2019-nCoV spike glycoprotein><2019-nCoV spike protein><2019-nCoV variant><2019-nCoV variant forms><2019-nCoV variant strains><7S Gamma Globulin><Ab-dependent cellular cytotoxicity><Administrative Supplement><Antibodies><Antibody Response><Assay><Autoimmune><Autoimmune Diseases><Autoimmune Status><Autoimmunity><B blood cells><B cell><B cells><B-Cells><B-Lymphocytes><B-cell><Binding><Bioassay><Biological Assay><Blood Sample><Blood specimen><CLIA accredited><CLIA approved><CLIA certified><CLIA compliant><CLIA licensed><COVID assay><COVID crisis><COVID epidemic><COVID infected patient><COVID pandemic><COVID patient><COVID positive patient><COVID-19 S protein><COVID-19 antibody><COVID-19 antigen><COVID-19 assay><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 immune response><COVID-19 infected patient><COVID-19 infection><COVID-19 pandemic><COVID-19 patient><COVID-19 period><COVID-19 positive patient><COVID-19 public health crisis><COVID-19 spike><COVID-19 spike glycoprotein><COVID-19 spike protein><COVID-19 variant><COVID-19 variant forms><COVID-19 variant strains><COVID-19 virus><COVID-19 virus infection><COVID-19 years><COVID19 assay><COVID19 infection><COVID19 patient><COVID19 positive patient><COVID19 virus><Cancers><Clinical><Clinical Evaluation><Clinical Immunology><Clinical Testing><CoV-2><CoV2><Collaborations><Communicable Diseases><Detection><Development><Diagnostic><ELISA><Enzyme-Linked Immunosorbent Assay><Evaluation><FDA EUA><FDA Emergency Use Authorization><Food and Drug Administration EUA><Food and Drug Administration Emergency Use Authorization><Funding><Future><Goals><Grant><Healthcare><Human><IgA><IgG><IgM><Immune><Immune Monitoring><Immune response><Immunes><Immunoassay><Immunoglobulin A><Immunoglobulin G><Immunoglobulin M><Immunologic Monitoring><Immunological Monitoring><Immunological response><Immunologist><Immunomodulation><Immunomonitoring><Infectious Disease Pathway><Infectious Diseases><Infectious Disorder><Investigators><Laboratories><Laboratory Research><Leadership><Malignant Neoplasms><Malignant Tumor><Measures><Medical><Medical Directors><Medicine><Membrane><Modern Man><Modification><Molecular Interaction><NIH><National Institutes of Health><Nucleocapsid><Oncology><Oncology Cancer><Pathologist><Pathology><Pathway interactions><Patients><Physician Executives><Position><Positioning Attribute><Productivity><Proteins><Reproducibility><Research><Research Personnel><Research Specimen><Researchers><Resource Sharing><Rheumatology><SARS corona virus 2><SARS-CO-V2><SARS-COVID-2><SARS-CoV-2><SARS-CoV-2 S><SARS-CoV-2 S protein><SARS-CoV-2 antibody><SARS-CoV-2 antigen><SARS-CoV-2 assay><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 immune response><SARS-CoV-2 infected patient><SARS-CoV-2 infection><SARS-CoV-2 pandemic><SARS-CoV-2 patient><SARS-CoV-2 positive patient><SARS-CoV-2 spike><SARS-CoV-2 spike glycoprotein><SARS-CoV-2 spike protein><SARS-CoV-2 variant><SARS-CoV-2 variant forms><SARS-CoV-2 variant strains><SARS-CoV2><SARS-CoV2 infection><SARS-associated corona virus 2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><SARS-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><Sampling><Serology><Serology test><Services><Severe Acute Respiratory Coronavirus 2><Severe Acute Respiratory Distress Syndrome CoV 2><Severe Acute Respiratory Distress Syndrome Corona Virus 2><Severe Acute Respiratory Distress Syndrome Coronavirus 2><Severe Acute Respiratory Syndrome CoV 2><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe Acute Respiratory Syndrome-associated coronavirus 2><Severe Acute Respiratory Syndrome-related coronavirus 2><Severe acute respiratory syndrome associated corona virus 2><Severe acute respiratory syndrome coronavirus 2><Severe acute respiratory syndrome coronavirus 2 S protein><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 immune response><Severe acute respiratory syndrome coronavirus 2 infection><Severe acute respiratory syndrome coronavirus 2 pandemic><Severe acute respiratory syndrome coronavirus 2 spike glycoprotein><Severe acute respiratory syndrome coronavirus 2 spike protein><Severe acute respiratory syndrome related corona virus 2><Site><Specimen><Testing><Training><Translating><Translational Research><Translational Science><United States National Institutes of Health><Variant><Variation><Viral><Viral Diseases><Viral Respiratory Tract Infection><Viral Vaccines><Virus Diseases><Work><Wuhan coronavirus><antibody against COVID-19><antibody against SARS-CoV-2><antibody against coronavirus disease 2019><antibody against severe acute respiratory syndrome coronavirus 2><antibody assay><antibody based test><antibody dependent cell mediated cytotoxicity><antibody dependent cytotoxicity><antibody mediated cellular cytotoxicity><antibody test><antibody to COVID-19><antibody to SARS-CoV-2><antibody to coronavirus disease 2019><antibody to severe acute respiratory syndrome coronavirus 2><antibody-dependent cell cytotoxicity><antibody-dependent cellular cytotoxicity><antibody-mediated cytotoxicity><autoimmune condition><autoimmune disorder><autoimmunity disease><clinical applicability><clinical application><clinical test><coronavirus disease 2019 S protein><coronavirus disease 2019 antibody><coronavirus disease 2019 antigen><coronavirus disease 2019 assay><coronavirus disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 immune response><coronavirus disease 2019 infected patient><coronavirus disease 2019 infection><coronavirus disease 2019 pandemic><coronavirus disease 2019 patient><coronavirus disease 2019 positive patient><coronavirus disease 2019 public health crisis><coronavirus disease 2019 spike glycoprotein><coronavirus disease 2019 spike protein><coronavirus disease 2019 variant><coronavirus disease 2019 variant forms><coronavirus disease 2019 variant strains><coronavirus disease 2019 virus><coronavirus disease assay><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease infected patient><coronavirus disease pandemic><coronavirus disease patient><coronavirus disease positive patient><coronavirus disease-19 global pandemic><coronavirus disease-19 pandemic><coronavirus disease-19 patient><coronavirus disease-19 virus><coronavirus patient><depository><design><designing><detection test><detection tests><developmental><diagnostic assay><emergency use authorization><enzyme linked immunoassay><hCoV19><health care><high throughput analysis><host response><immune modulation><immune regulation><immune system response><immunologic reactivity control><immunomodulatory><immunoregulation><immunoregulatory><immunoresponse><improved><infected with COVID-19><infected with COVID19><infected with SARS-CoV-2><infected with SARS-CoV2><infected with coronavirus disease 2019><infected with severe acute respiratory syndrome coronavirus 2><innovate><innovation><innovative><malignancy><meeting><meetings><membrane structure><nCoV2><neoplasm/cancer><pathogenic virus><pathway><patient infected with COVID><patient infected with COVID-19><patient infected with SARS-CoV-2><patient infected with coronavirus disease><patient infected with coronavirus disease 2019><patient infected with severe acute respiratory syndrome coronavirus 2><patient population><patient with COVID><patient with COVID-19><patient with COVID19><patient with SARS-CoV-2><patient with coronavirus disease><patient with coronavirus disease 2019><patient with severe acute respiratory distress syndrome coronavirus 2><professor><prospective><receptor binding><receptor bound><repository><research clinical testing><response><serology assay><serology surveillance><serosurveillance><severe acute respiratory syndrome coronavirus 2 antibody><severe acute respiratory syndrome coronavirus 2 antigen><severe acute respiratory syndrome coronavirus 2 assay><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><severe acute respiratory syndrome coronavirus 2 infected patient><severe acute respiratory syndrome coronavirus 2 patient><severe acute respiratory syndrome coronavirus 2 positive patient><severe acute respiratory syndrome coronavirus 2 variant><severe acute respiratory syndrome coronavirus 2 variant forms><severe acute respiratory syndrome coronavirus 2 variant strains><spike proteins on SARS-CoV-2><translation research><translational investigation><viral infection><viral pathogen><viral respiratory infection><virus infection><virus pathogen><virus-induced disease>