MYCOBACTERIUM TUBERCULOSIS (MTB) QUALITY ASSESSMENT PROGRAM (TBQA)

结核分枝杆菌 (MTB) 质量评估计划 (TBQA)

基本信息

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
项目类别：
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

项目摘要

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资源，以评估位于美国（美国）和外部（非U.S）实验室的能力，以准确且可靠地可靠地执行MTB测试，以诊断和潜在的MTB感染，对临床疾病的进步效率进行诊断和评估效率，并对其进行了效果，并效果受到评估和评估效率，并进行了对效果的效果，并促进了对疾病的效率进行验证。随着新的测试/方法的开发，TBQA计划将支持其适应，标准化和质量评估，然后再将其纳入NIAID支持的临床研究。 TBQA计划将为NIAID赞助和协作的临床试验网络和同伙以及在美国境内及以外进行研究的个别大人。 NIAID赞助的网络的示例包括成人艾滋病临床试验组（ACTG），国际母性小儿和青少年艾滋病临床试验组（INCACT）和HIV疫苗试验网络（HVTN）。 NIAID赞助的队列的例子包括印度和巴西的结核病观察研究（报告）。合作用户组的例子包括CDC，全球结核病药物开发联盟和美国军事艾滋病毒研究计划。 TBQA合同将负责监测实验室准确，可靠地研究指定的MTB测试的能力（例如，下一代细菌DNA和RNA测序，在固体培养基上的串行痰液，液态培养的时间，最小抑制性浓度评估的潜在时间，以及基于宿主的评估）。这将包括准备熟练度测试面板（或从商业和非商业资源中获取），分配给参与实验室，捕获和统计分析从实验室获得的测试结果，确定绩效可接受性以及生成实验室特定的绩效报告。当Labs的测试性能不可接受时，TBQA将提供纠正措施的帮助，指导和培训。