COVID-19: NIAID VIROLOGY QUALITY ASSURANCE (VQA)
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Principal Investigator: THOMAS DENNY Organization: DUKE UNIVERSITY Fiscal Year: 2021 Award: $641,460 Funding agency: National Institute of Allergy and Infectious Diseases The purpose of the NIAID Virology Quality Assurance (VQA) program is to provide a comprehensive quality assessment program for virologic assays for HIV, and other viral pathogens, performed on samples from subjects enrolled in NIAID-sponsored multisite clinical studies. The VQA program ensures the validity and inter- and intra-laboratory comparability of virologic laboratory data obtained from NIAID-supported clinical trials and HIV natural history studies by providing laboratories with proficiency testing panels and real-time assay run controls and analyzing proficiency panel and assay run data from each laboratory. The VQA program also implements standards of performance for existing and state-of-the-art new virologic assays, develops and tests biostatistical methods relating to the assays, and acquires, tests, stores and dispenses quality control materials and reagents. Support under this project is for SARS-CoV-2 (COVID-19) virologic assay quality assurance activities. Terms: <2019 novel corona virus><2019 novel coronavirus><2019-nCoV><2019-nCoV variant><2019-nCoV variant forms><2019-nCoV variant strains><AIDS Virus><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome Virus><Antibodies><Assay><B.1.1.7><B.1.351><Bioassay><Biologic Assays><Biological Assay><Biostatistical Methods><Blood Plasma><British><British Columbia><COVID-19><COVID-19 infection><COVID-19 variant><COVID-19 variant forms><COVID-19 variant strains><COVID-19 virus><COVID19><COVID19 infection><COVID19 virus><CV-19><CV19><Clinical Trials><CoV-2><CoV2><Coronaviridae><Coronavirus><Data><Enrollment><Ensure><HIV><Human Immunodeficiency Viruses><Individual><Investigators><LAV-HTLV-III><Laboratories><Leukapheresis><Leukocytapheresis><Lymphadenopathy-Associated Virus><Multi-center clinical study><Multi-site clinical study><Multicenter clinical study><Multisite clinical study><NIAID><National Institute of Allergy and Infectious Disease><Natural History><Neutralization Tests><PBMC><Performance><Peripheral Blood Mononuclear Cell><Plasma><Plasma Serum><Plasmapheresis><Preparation><Quality Control><Reagent><Research Personnel><Researchers><Reticuloendothelial System, Serum, Plasma><Running><SARS corona virus 2><SARS-CoV-2><SARS-CoV-2 B.1.1.7><SARS-CoV-2 B.1.351><SARS-CoV-2 infection><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-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><Sampling><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-associated coronavirus 2><Severe Acute Respiratory Syndrome-related coronavirus 2><Severe acute respiratory syndrome associated corona virus 2><Severe acute respiratory syndrome corona virus 2><Severe acute respiratory syndrome coronavirus 2><Severe acute respiratory syndrome coronavirus 2 infection><Severe acute respiratory syndrome related corona virus 2><Ships><South Africa><South Africa variant><South African variant><Testing><Therapeutic Leukopheresis><Therapeutic Plasma Exchange><Therapeutic Plasmapheresis><Time><U.K. variant><UK variant><United Kingdom variant><Universities><Variant><Variation><Virus-HIV><Wuhan coronavirus><antibody neutralization test><corona virus><corona virus disease 2019><coronavirus disease 2019><coronavirus disease 2019 infection><coronavirus disease 2019 variant><coronavirus disease 2019 variant forms><coronavirus disease 2019 variant strains><coronavirus disease 2019 virus><depository><enroll><hCoV19><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><nCoV2><pathogenic virus><programs><quality assurance><repository><severe acute respiratory syndrome coronavirus 2 B.1.1.7><severe acute respiratory syndrome coronavirus 2 B.1.351><severe acute respiratory syndrome coronavirus 2 variant><severe acute respiratory syndrome coronavirus 2 variant forms><severe acute respiratory syndrome coronavirus 2 variant strains><variants of concern><viral pathogen><virology><virus pathogen>