MYCOBACTERIUM TUBERCULOSIS (MTB) QUALITY ASSESSMENT PROGRAM (TBQA)

结核分枝杆菌 (MTB) 质量评估计划 (TBQA)

• 批准号: 10788125
• 负责人: JEANETTE COFFIN
• 金额: $ 157.87万
• 依托单位: MIDWEST RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10788125
• 关键词: AIDS clinical trial group; Adult; Bacterial DNA; Biological Assay; Blood; Brazil; Childhood; Clinical; Clinical Trials; Clinical Trials Network; Collaborations; Collection; Contracts; DNA sequencing; Diagnosis; Disease Progression; Evaluation; Evaluation Studies; Generations; Genetic Variation; Geography; HIV; HIV Infections; HIV Vaccine Trials Network; India; Individual; International Maternal Pediatric Adolescent AIDS Clinical Trials; Laboratories; Liquid substance; Methodology; Methods; Military Personnel; Monitor; Mycobacterium tuberculosis; National Institute of Allergy and Infectious Disease; Non-Commercial Sources; Observational Study; Performance; Preparation; Procedures; Quality Control; Reagent; Reporting; Research; Resources; Saliva; Sampling; Shipping; Solid; Source; Specific qualifier value; Sputum; Standardization; Statistical Data Interpretation; Test Result; Testing; Time; Training; Tuberculosis; United States; Urine; clinical investigation; cohort; design; drug development; drug-sensitive; minimal inhibitory concentration; next generation; novel; performance tests; point of care testing; programs; prospective; resistant strain; sample collection; therapeutic vaccine; transcriptome sequencing; treatment response; tuberculosis drugs; vaccine efficacy

The purpose of the Mycobacterium Tuberculosis (Mtb) Quality Assessment Program (TBQA) is to provide a new resource to assess the ability of laboratories located both in the United States (U.S.) and outside (non-U.S.) to accurately and reliably perform Mtb testing to diagnose active and latent Mtb infection, monitor disease progression, and assess treatment response and vaccine efficacy in direct support of clinical trials. As new tests/methodologies are developed, the TBQA program will facilitate their adaptation, standardization and quality assessment prior to inclusion in NIAID-supported clinical investigations. The TBQA program will serve NIAID-sponsored and collaborating clinical trials networks and cohorts as well as individual grantees conducting research in and outside the United States. Examples of NIAID-sponsored Networks include the Adult AIDS Clinical Trials Group (ACTG), the International Maternal Pediatric and Adolescent AIDS Clinical Trials Group (IMPAACT) and the HIV Vaccine Trials Network (HVTN). Examples of NIAID-sponsored cohorts include the India and Brazil Regional Prospective Observational Research for Tuberculosis (RePORT). Examples of collaborating User Groups include the CDC, the Global Alliance for TB Drug Development, and the US Military HIV Research Program. The TBQA contract will be responsible for monitoring Labs’ ability to perform accurately and reliably study-specified Mtb tests (e.g. next-generation bacterial DNA and RNA sequencing, serial sputum colony count on solid media, time to positivity in liquid culture, minimal inhibitory concentration assessment, and host-based assays). This will include preparation of proficiency testing panels (or acquisition from commercial and non-commercial sources), distribution to participating laboratories, capture and statistical analysis of test results obtained from Labs, determination of performance acceptability, and generation of Lab-specific performance reports. The TBQA will provide assistance, guidance and training in corrective action when Labs’ test performance is unacceptable.

结核分枝杆菌(MTB)质量评估计划(TBQA)的目的是提供一种新的资源来评估位于美国(美国)的实验室的能力。和境外(非美国)准确可靠地进行结核分枝杆菌检测，以诊断活动性和潜伏性结核分枝杆菌感染，监测疾病进展，评估治疗反应和疫苗效力，直接支持临床试验。随着新的测试/方法的开发，在纳入NIAID支持的临床研究之前，TBQA计划将促进它们的适应、标准化和质量评估。TBQA计划将为NIAID赞助和合作的临床试验网络和队列以及在美国国内外进行研究的个人受赠者提供服务。NIAID赞助的网络的例子包括成人艾滋病临床试验小组(ACTG)、国际母亲、儿童和青少年艾滋病临床试验小组(IMPAACT)和艾滋病毒疫苗试验网络(HVTN)。NIAID赞助的队列的例子包括印度和巴西结核病区域前瞻性观察性研究(报告)。合作用户团体的例子包括疾控中心、全球结核病药物开发联盟和美国军方艾滋病毒研究计划。 TBQA合同将负责监测Labs准确和可靠地执行研究指定的结核分枝杆菌检测的能力(例如，下一代细菌DNA和RNA测序、固体培养上的连续痰菌落计数、液体培养中阳性的时间、最低抑菌浓度评估和基于宿主的分析)。这将包括准备能力测试小组(或从商业和非商业来源获取)，向参与实验室分发，捕获和统计分析从实验室获得的测试结果，确定性能可接受性，以及生成特定于实验室的性能报告。当实验室的测试表现不能接受时，TBQA将在纠正措施方面提供帮助、指导和培训。