NIAID VIROLOGY QUALITY ASSURANCE (VQA)

NIAID 病毒学质量保证 (VQA)

• 批准号: 10868384
• 负责人: THOMAS DENNY
• 金额: $ 400.91万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-21 至 2024-06-20
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10868384
• 关键词: Biological Assay; Biometry; Biostatistical Methods; Clinical Trials; Cytomegalovirus; Data; Enrollment; Ensure; Evaluation; HIV; Hepatitis B Virus; Hepatitis C virus; Human Herpesvirus 8; Human Papillomavirus; Infectious Agent; Laboratories; Methodology; Multi-site clinical study; National Institute of Allergy and Infectious Disease; Natural History; Performance; Quality Control; Reagent; Running; Sampling; Simplexvirus; Standardization; Testing; Time; Viral; co-infection; pathogen; pathogenic virus; programs; quality assurance; virology

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.

NIAID病毒学质量保证（VQA）计划的目的是为HIV和其他病毒病原体的病毒学检测提供全面的质量评估计划，这些检测是对NIAID申办的多中心临床研究中入组的受试者样本进行的。VQA计划通过为实验室提供熟练度检测组和实时检测运行质控品，并分析每个实验室的熟练度检测组和检测运行数据，确保从NIAID支持的临床试验和HIV自然史研究中获得的病毒学实验室数据的有效性和实验室间及实验室内可比性。VQA计划还实施现有和最先进的新病毒学检测的性能标准，开发和测试与检测相关的生物统计方法，并获取，测试，储存和分配质量控制材料和试剂。