COVID-19: External Quality Assurance Program Oversight Laboratory (EQAPOL)

COVID-19：外部质量保证计划监督实验室 (EQAPOL)

• 批准号: 10930677
• 负责人: THOMAS DENNY
• 金额: $ 183.02万
• 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: 2023-09-30 至 2024-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10930677
• 关键词: 2019-nCoV; Acquired Immunodeficiency Syndrome; Antigens; Binding; Biological Assay; Biometry; COVID-19; COVID-19 Prevention Network; COVID-19 assay; Data; Development; Flow Cytometry; HIV; HIV Infections; HIV vaccine; Immunology; Immunology procedure; Individual; Knowledge; Laboratories; Measures; Mission; Monitor; National Institute of Allergy and Infectious Disease; Pathogenesis; Performance; Prevention strategy; Procedures; Reagent; Reproducibility; SARS-CoV-2 antibody; Stains; United States National Institutes of Health; cytokine; data management; data quality; design; efficacy trial; programs; quality assurance; repository; research clinical testing; therapy development; transmission process; vaccine candidate; vaccine development; vaccine efficacy; vaccine platform

The mission of the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is to increase basic knowledge of the pathogenesis and transmission of the human immunodeficiency virus (HIV), support the development of therapies for HIV infection and its complications, and support the development of vaccines and other prevention strategies. Reliable laboratory data are essential to the clinical evaluation of candidate HIV vaccine platforms and immunogens. Data from multiple laboratories performing assays in support of single or multiple vaccine candidate trials must be accurate and reproducible. The purpose of the External Quality Assurance Program Oversight Laboratory (EQAPOL) is to provide confidence that individual laboratories generate reliable data to support HIV vaccine immunogen advancement. EQAPOL supports these efforts by participating in the development and availability of validated assays, providing common and well-characterized reagents and Standard Operating Procedures (SOPs), and providing External Quality Assurance (EQA) programs to measure and monitor laboratory performance. This project will provide external quality assurance program support for laboratories performing immunology assays for COVID-19 Prevention Network (CoVPN)-led vaccine efficacy trials.

美国国立卫生研究院（NIH）国家过敏和传染病研究所（NIAID）艾滋病司（DAIDS）的使命是增加对人类免疫缺陷病毒（HIV）发病机理和传播的基本知识，支持开发HIV感染及其并发症的治疗方法，并支持开发疫苗和其他预防战略。可靠的实验室数据对于候选HIV疫苗平台和免疫原的临床评价至关重要。为支持单一或多个候选疫苗试验而进行的多个实验室的数据必须准确且可重现。外部质量保证计划监督实验室（EQAPOL）的目的是确保各个实验室能够生成可靠的数据，以支持HIV疫苗免疫原的发展。EQAPOL通过参与开发和提供经验证的检测试剂盒，提供通用和良好表征的试剂和标准操作规程（SOP），以及提供外部质量保证（EQA）计划来测量和监测实验室性能，从而支持这些努力。该项目将为实验室提供外部质量保证计划支持，这些实验室为COVID-19预防网络（CoVPN）领导的疫苗有效性试验进行免疫学检测。