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的病毒学测定和其他病毒病原体提供全面的质量评估计划，该计划对来自NIAID赞助的多站点临床研究的受试者的样本进行了样本。 VQA计划可确保通过为NIAID支持的临床试验获得的病毒学实验室数据的有效性以及实验室间比较性，并通过为实验室提供熟练度测试面板和实时测定运行控制和分析每个实验室的数据，从而从NIAID支持的临床试验和HIV自然历史研究中获得了可比性。 VQA计划还针对现有和最先进的新病毒学测定法实现了绩效标准，开发和测试了与测定法有关的生物统计学方法，并获取，测试，存储和分配优质的控制材料和试剂。