NIAID VIROLOGY QUALITY ASSURANCE (VQA) COVID-19
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Principal Investigator: THOMAS DENNY Organization: DUKE UNIVERSITY Fiscal Year: 2020 Award: $668,265 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 coronavirus><2019-nCoV><AIDS Virus><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome Virus><Assay><Bioassay><Biologic Assays><Biological Assay><Biostatistical Methods><Blood><Blood Plasma><Blood Reticuloendothelial System><Blood Sample><Blood Serum><Blood specimen><COVID-19><COVID19><Cell Body><Cells><Clinical Trials><Data><Diagnosis><Enrollment><Ensure><HIV><Human Immunodeficiency Viruses><Infection><Inpatients><LAV-HTLV-III><Laboratories><Lymphadenopathy-Associated Virus><Methods><Multi-center clinical study><Multi-site clinical study><Multicenter clinical study><Multisite clinical study><NIAID><National Institute of Allergy and Infectious Disease><Natural History><Out-patients><Outpatients><Patients><Performance><Plasma><Plasma Serum><Quality Control><RT-PCR><RTPCR><Reagent><Research><Reticuloendothelial System, Serum, Plasma><Reverse Transcriptase Polymerase Chain Reaction><Running><SARS-CoV-2><SARS-CoV2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related coronavirus 2><Saliva><Sampling><Serum><Severe acute respiratory syndrome coronavirus 2><Site><Swab><Testing><Time><Tube><Validation><Viral><Viral Burden><Viral Load><Viral Load result><Virus><Virus-HIV><Wuhan coronavirus><corona virus disease 2019><coronavirus disease 2019><enroll><pathogenic virus><programs><quality assurance><reverse transcriptase PCR><viral pathogen><virology>